scholarly journals Septum resection in women with a septate uterus: a cohort study

2020 ◽  
Vol 35 (7) ◽  
pp. 1578-1588 ◽  
Author(s):  
J F W Rikken ◽  
K W J Verhorstert ◽  
M H Emanuel ◽  
M Y Bongers ◽  
T Spinder ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Live Birth ◽  
Classification System ◽  
Pregnancy Loss ◽  
Expectant Management ◽  
Reproductive Outcomes ◽  
Ongoing Pregnancy ◽  
Septate Uterus ◽  
Definition Of

Abstract Study question Does septum resection improve reproductive outcomes in women with a septate uterus? Summary answer In women with a septate uterus, septum resection does not increase live birth rate nor does it decrease the rates of pregnancy loss or preterm birth, compared with expectant management. What is known already The septate uterus is the most common uterine anomaly with an estimated prevalence of 0.2–2.3% in women of reproductive age, depending on the classification system. The definition of the septate uterus has been a long-lasting and ongoing subject of debate, and currently two classification systems are used worldwide. Women with a septate uterus may be at increased risk of subfertility, pregnancy loss, preterm birth and foetal malpresentation. Based on low quality evidence, current guidelines recommend removal of the intrauterine septum or, more cautiously, state that the procedure should be evaluated in future studies. Study design, size, duration We performed an international multicentre cohort study in which we identified women mainly retrospectively by searching in electronic patient files, medical records and databases within the time frame of January 2000 until August 2018. Searching of the databases, files and records took place between January 2016 and July 2018. By doing so, we collected data on 257 women with a septate uterus in 21 centres in the Netherlands, USA and UK. Participants/materials, setting, methods We included women with a septate uterus, defined by the treating physician, according to the classification system at that time. The women were ascertained among those with a history of subfertility, pregnancy loss, preterm birth or foetal malpresentation or during a routine diagnostic procedure. Allocation to septum resection or expectant management was dependent on the reproductive history and severity of the disease. We excluded women who did not have a wish to conceive at time of diagnosis. The primary outcome was live birth. Secondary outcomes included pregnancy loss, preterm birth and foetal malpresentation. All conceptions during follow-up were registered but for the comparative analyses, only the first live birth or ongoing pregnancy was included. To evaluate differences in live birth and ongoing pregnancy, we used Cox proportional regression to calculate hazard rates (HRs) and 95% CI. To evaluate differences in pregnancy loss, preterm birth and foetal malpresentation, we used logistic regression to calculate odds ratios (OR) with corresponding 95% CI. We adjusted all reproductive outcomes for possible confounders. Main results and the role of chance In total, 257 women were included in the cohort. Of these, 151 women underwent a septum resection and 106 women had expectant management. The median follow-up time was 46 months. During this time, live birth occurred in 80 women following a septum resection (53.0%) compared to 76 women following expectant management (71.7%) (HR 0.71 95% CI 0.49–1.02) and ongoing pregnancy occurred in 89 women who underwent septum resection (58.9%), compared to 80 women who had expectant management (75.5%) (HR 0.74 (95% CI 0.52–1.06)). Pregnancy loss occurred in 51 women who underwent septum resection (46.8%) versus 31 women who had expectant management (34.4%) (OR 1.58 (0.81–3.09)), while preterm birth occurred in 26 women who underwent septum resection (29.2%) versus 13 women who had expectant management (16.7%) (OR 1.26 (95% CI 0.52–3.04)) and foetal malpresentation occurred in 17 women who underwent septum resection (19.1%) versus 27 women who had expectant management (34.6%) (OR 0.56 (95% CI 0.24–1.33)). Limitations, reasons for caution Our retrospective study has a less robust design compared with a randomized controlled trial. Over the years, the ideas about the definition of the septate uterus has changed, but since the 257 women with a septate uterus included in this study had been diagnosed by their treating physician according to the leading classification system at that time, the data of this study reflect the daily practice of recent decades. Despite correcting for the most relevant patient characteristics, our estimates might not be free of residual confounding. Wider implications of the findings Our results suggest that septum resection, a procedure that is widely offered and associated with financial costs for society, healthcare systems or individuals, does not lead to improved reproductive outcomes compared to expectant management for women with a septate uterus. The results of this study need to be confirmed in randomized clinical trials. Study funding/competing interest(s) A travel for JFWR to Chicago was supported by the Jo Kolk Studyfund. Otherwise, no specific funding was received for this study. The Department of Obstetrics and Gynaecology, University Medical Centre, Groningen, received an unrestricted educational grant from Ferring Pharmaceutical Company unrelated to the present study. BWM reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck, personal fees from Guerbet, other payment from Guerbet and grants from Merck, outside the submitted work. The other authors declare no conficts of interest. Trial registration number N/A

scholarly journals Septum resection versus expectant management in women with a septate uterus: an international multicentre open-label randomized controlled trial

2021 ◽  
Vol 36 (5) ◽  
pp. 1260-1267
Author(s):  
J F W Rikken ◽  
C R Kowalik ◽  
M H Emanuel ◽  
M Y Bongers ◽  
T Spinder ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Live Birth ◽  
Pregnancy Loss ◽  
Controlled Trial ◽  
Expectant Management ◽  
Reproductive Outcomes ◽  
Open Label ◽  
Septate Uterus ◽  
Intention To Treat ◽  
Randomized Controlled

Abstract STUDY QUESTION Does septum resection improve reproductive outcomes in women with a septate uterus? SUMMARY ANSWER Hysteroscopic septum resection does not improve reproductive outcomes in women with a septate uterus. WHAT IS KNOWN ALREADY A septate uterus is a congenital uterine anomaly. Women with a septate uterus are at increased risk of subfertility, pregnancy loss and preterm birth. Hysteroscopic resection of a septum may improve the chance of a live birth in affected women, but this has never been evaluated in randomized clinical trials. We assessed whether septum resection improves reproductive outcomes in women with a septate uterus, wanting to become pregnant. STUDY DESIGN, SIZE, DURATION We performed an international, multicentre, open-label, randomized controlled trial in 10 centres in The Netherlands, UK, USA and Iran between October 2010 and September 2018. PARTICIPANTS/MATERIALS, SETTING, METHODS Women with a septate uterus and a history of subfertility, pregnancy loss or preterm birth were randomly allocated to septum resection or expectant management. The primary outcome was conception leading to live birth within 12 months after randomization, defined as the birth of a living foetus beyond 24 weeks of gestational age. We analysed the data on an intention-to-treat basis and calculated relative risks with 95% CI. MAIN RESULTS AND THE ROLE OF CHANCE We randomly assigned 80 women with a septate uterus to septum resection (n = 40) or expectant management (n = 40). We excluded one woman who underwent septum resection from the intention-to-treat analysis, because she withdrew informed consent for the study shortly after randomization. Live birth occurred in 12 of 39 women allocated to septum resection (31%) and in 14 of 40 women allocated to expectant management (35%) (relative risk (RR) 0.88 (95% CI 0.47 to 1.65)). There was one uterine perforation which occurred during surgery (1/39 = 2.6%). LIMITATIONS, REASONS FOR CAUTION Although this was a major international trial, the sample size was still limited and recruitment took a long period. Since surgical techniques did not fundamentally change over time, we consider the latter of limited clinical significance. WIDER IMPLICATIONS OF THE FINDINGS The trial generated high-level evidence in addition to evidence from a recently published large cohort study. Both studies unequivocally do not reveal any improvements in reproductive outcomes, thereby questioning any rationale behind surgery. STUDY FUNDING/COMPETING INTEREST(S) There was no study funding. M.H.E. reports a patent on a surgical endoscopic cutting device and process for the removal of tissue from a body cavity licensed to Medtronic, outside the scope of the submitted work. H.A.v.V. reports personal fees from Medtronic, outside the submitted work. B.W.J.M. reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck Merck KGaA, personal fees from Guerbet, personal fees from iGenomix, outside the submitted work. M.G. reports several research and educational grants from Guerbet, Merck and Ferring (location VUMC) outside the scope of the submitted work. The remaining authors have nothing to declare. TRIAL REGISTRATION NUMBER Dutch trial registry: NTR 1676 TRIAL REGISTRATION DATE 18 February 2009 DATE OF FIRST PATIENT’S ENROLMENT 20 October 2010

scholarly journals Comparative effectiveness of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa) versus highly purified urinary human menopausal gonadotropin (hMG HP) in assisted reproductive technology (ART) treatments: a non-interventional study in Germany

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Klaus F. Bühler ◽  
Robert Fischer ◽  
Patrice Verpillat ◽  
Arthur Allignol ◽  
Sandra Guedes ◽  
...  
Keyword(s):  
Assisted Reproductive Technology ◽  
Live Birth ◽  
Pregnancy Loss ◽  
Follicle Stimulating Hormone ◽  
Reproductive Technology ◽  
Clinical Pregnancy ◽  
Human Menopausal Gonadotropin ◽  
Ongoing Pregnancy ◽  
Complete Cycle ◽  
Significant Difference

Abstract Background This study compared the effectiveness of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa; GONAL-f®) with urinary highly purified human menopausal gonadotropin (hMG HP; Menogon HP®), during assisted reproductive technology (ART) treatments in Germany. Methods Data were collected from 71 German fertility centres between 01 January 2007 and 31 December 2012, for women undergoing a first stimulation cycle of ART treatment with r-hFSH-alfa or hMG HP. Primary outcomes were live birth, ongoing pregnancy and clinical pregnancy, based on cumulative data (fresh and frozen-thawed embryo transfers), analysed per patient (pP), per complete cycle (pCC) and per first complete cycle (pFC). Secondary outcomes were pregnancy loss (analysed per clinical pregnancy), cancelled cycles (analysed pCC), total drug usage per oocyte retrieved and time-to-live birth (TTLB; per calendar week and per cycle). Results Twenty-eight thousand six hundred forty-one women initiated a first treatment cycle (r-hFSH-alfa: 17,725 [61.9%]; hMG HP: 10,916 [38.1%]). After adjustment for confounding variables, treatment with r-hFSH-alfa versus hMG HP was associated with a significantly higher probability of live birth (hazard ratio [HR]-pP [95% confidence interval (CI)]: 1.10 [1.04, 1.16]; HR-pCC [95% CI]: 1.13 [1.08, 1.19]; relative risk [RR]-pFC [95% CI]: 1.09 [1.05, 1.15], ongoing pregnancy (HR-pP [95% CI]: 1.10 [1.04, 1.16]; HR-pCC [95% CI]: 1.13 [1.08, 1.19]; RR-pFC [95% CI]: 1.10 [1.05, 1.15]) and clinical pregnancy (HR-pP [95% CI]: 1.10 [1.05, 1.14]; HR-pCC [95% CI]: 1.14 [1.10, 1.19]; RR-pFC [95% CI]: 1.10 [1.06, 1.14]). Women treated with r-hFSH-alfa versus hMG HP had no statistically significant difference in pregnancy loss (HR [95% CI]: 1.07 [0.98, 1.17], were less likely to have a cycle cancellation (HR [95% CI]: 0.91 [0.84, 0.99]) and had no statistically significant difference in TTLB when measured in weeks (HR [95% CI]: 1.02 [0.97, 1.07]; p = 0.548); however, r-hFSH-alfa was associated with a significantly shorter TTLB when measured in cycles versus hMG HP (HR [95% CI]: 1.07 [1.02, 1.13]; p = 0.003). There was an average of 47% less drug used per oocyte retrieved with r-hFSH-alfa versus hMG HP. Conclusions This large (> 28,000 women), real-world study demonstrated significantly higher rates of cumulative live birth, cumulative ongoing pregnancy and cumulative clinical pregnancy with r-hFSH-alfa versus hMG HP.

P–708 Comparison of reproductive outcomes after progestin-primed ovarian stimulation with dydrogesterone versus cetrorelix to inhibit spontaneous ovulation in oocyte donation

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
J A Moreno ◽  
P Masoli ◽  
C Sferrazza ◽  
H Leiva ◽  
O Espinosa ◽  
...  
Keyword(s):  
Pregnancy Rate ◽  
Live Birth ◽  
Ovarian Stimulation ◽  
Fertilization Rate ◽  
Oocyte Donation ◽  
Pregnancy Rates ◽  
Clinical Pregnancy ◽  
Reproductive Outcomes ◽  
Ongoing Pregnancy ◽  
Live Births

Abstract Study question Is dydrogesterone (DYG) equivalent compared to cetrorelix with respect to clinical pregnancy rate, ongoing pregnancy rate and live birth rate in oocyte donation (OD) cycles? Summary answer DYG is comparable to cetrorelix in terms of clinical pregnancy, but higher rates of ongoing pregnancy and live birth were observed in the DYG group What is known already Progestin-primed ovarian stimulation (PPOS) is an ovarian stimulation regimen based on a freeze-all strategy using progestin as an alternative to GnRH analog for suppressing a premature LH surge. DYG is an oral progestin that has been studied in PPOS protocols. Published reports indicate that length of ovarian stimulation, dose of gonadotrophin needed and number of MII retrieved from PPOS cycles are comparable to short protocol of GnRH agonists during OD cycles. However, while some studies noted no differences in terms of live births, worse pregnancy rates have been reported in recipients of oocytes from PPOS cycles compared to GnRH antagonists. Study design, size, duration Prospective controlled study to assess the reproductive outcomes of OD recipients in which the donors were subjected to the DYG protocol (20mg/day) compared with those subjected to the short protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm. The OD cycles were triggered with triptoreline acetate and the trigger criterion was ≥3 follicles of diameter >18mm. Participants/materials, setting, methods 202 oocyte donors were included, 92 under DYG and 110 under cetrorelix. The study was performed in a private infertility center between January 2017 and December 2020. The main outcome included the rates of clinical pregnancy, ongoing pregnancy and live births. Secondary outcomes included the number of oocytes retrieved, number of MII, fertilization rate, length of stimulation and total gonadotropin dose. Differences were tested using a Student’s t-test or a Chi2 test, as appropriate. Main results and the role of chance Compared to antagonist cycles, cycles under DYG had fewer days of stimulation (9.9 ± 0.9 vs. 10.8 ± 1.1, p<.001) and a lower total gonadotropin dose (1654 ± 402.4 IU vs. 1844 ± 422 IU, p<.001). The number of MII retrieved was no different: 16.9 (SD 6.2) with DYG and 15.4 (SD 5.8) with cetrorelix (p = 0.072). Recipients and embryo transfer (ET) characteristics were also similar between groups. The mean number of MII assigned to each recipients was 6.7 (SD 1.8) in DYG and 6.6 (SD 1.7) in cetrorelix (P = 0.446). The fertilization rate was 66.2% in DYG versus 67.6% in cetrorelix (P = 0.68). Regarding the reproductive outcomes, the overall clinical pregnancy rate in DYG group (65/87: 74.7%) and cetrorelix group (66/104: 63.4%) (p = 0.118) was similar. Meanwhile, the DYG group compared to cetrorelix group had higher rates of ongoing pregnancy (63.2% vs 45.1%; p = 0.014) and live births (54,9% vs 37.8%; p = 0.040). Limitations, reasons for caution These results should be evaluated with caution. The limitations of this study include the limited number of participants enrolled and the limited data on pregnancy outcomes. A randomized controlled trial is necessary to provide more evidence on the efficacy of the DYG protocol. Wider implications of the findings: The efficacy of PPOS protocol compared to GnRH-antagonist protocol in terms of reproductive outcomes has been little studied. PPOS using DYG yields comparable clinical pregnancy rates compared to cetrorelix in OD cycles. The differences found regarding the rates of ongoing pregnancy and live births should be further investigated. Trial registration number Not applicable

O-138 Reproductive performance of women with and without intrauterine adhesions following recurrent dilatation and curettage for miscarriage: long-term follow-up of a randomized controlled trial

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
A Hooker ◽  
R A Leeuw ◽  
J Twisk ◽  
H Brolmann ◽  
J Huirne
Keyword(s):  
Live Birth ◽  
Reproductive Performance ◽  
Controlled Trial ◽  
P Value ◽  
Reproductive Outcomes ◽  
Intrauterine Adhesions ◽  
Randomized Controlled ◽  
Dilatation And Curettage

Abstract Study question Are the long-term reproductive outcomes following recurrent dilatation and curettage (D&C) for miscarriage in women with identified and treated intrauterine adhesions (IUAs) comparable to women without IUAs. Summary answer Reproductive outcomes in women with identified and treated IUAs following recurrent D&C for miscarriage are impaired compared to women without IUAs. What is known already The Prevention of Adhesions Post Abortion (PAPA) study showed that application of auto-crosslinked hyaluronic acid (ACP) gel, an absorbable barrier in women undergoing recurrent D&C for miscarriage resulted in a lower rate of IUAs, 13% versus 31% (relative risk 0.43, 95% CI 0.22 to 0.83), lower mean adhesion score and significant less moderate to severe IUAs. It is unclear what the impact is of IUAs on long-term reproductive performance. Study design, size, duration This was a follow-up of the PAPA study, a multicenter randomized controlled trial evaluating the application of ACP gel in women undergoing recurrent D&C for miscarriage. All included women received a diagnostic hysteroscopy 8–12 weeks after randomization to evaluate the uterine cavity and for adhesiolysis if IUAs were present. Here, we present the reproductive outcomes in women with identified and treated IUAs versus women without IUAs, 46 months after randomization. Participants/materials, setting, methods Between December 2011 and July 2015, 152 women with a first-trimester miscarriage with at least one previous D&C, were randomized for D&C alone or D&C with immediate intrauterine application of ACP gel. Participants were approached at least 30 months after randomization to evaluate reproductive performance, obstetric and neonatal outcomes and cycle characteristics. Main outcome was ongoing pregnancy. Outcomes of subsequent pregnancies, time to conception and time to live birth were also recorded. Main results and the role of chance In women pursuing a pregnancy, 14/24 (58%) ongoing pregnancies were recorded in women with identified and treated IUAs versus 80/89 (90%) ongoing pregnancies in women without IUAs odds ratio (OR) 0.18 (95% CI 0.06 to 0.50, P-value <0.001). Documented live birth was also lower in women with IUAs; 13/24 (54%) with versus 75/89 (84%) without IUAs, OR 0.22 (95% CI: 0.08 to-0.59, P-value 0.004). The median time to conception was 7 months in women with identified and treated IUAs versus 5 months in women without IUAs (hazard ratio (HR) 0.84 (95% CI 0.54 to 1.33)) and time to conception leading to a live birth 15 months versus 5.0 months (HR 0.54 (95% CI: 0.30 to 0.97)). In women with identified and treated IUAs, premature deliveries were recorded in 3/16 (19%) versus 4/88 (5%) in women without IUAs, P-value 0.01. Complications were recorded in respectively 12/16 (75%) versus 26/88 (30%), P-value 0.001. No differences were recorded in mean birth weight between the groups. Limitations, reasons for caution In the original PAPA study, randomization was applied for ACP gel application. Comparing women with and without IUAs is not in line with the randomization and therefore confounding of the results cannot be excluded. IUAs, if visible during routine hysteroscopy after randomization were removed as part of the study protocol. Wider implications of the findings As IUAs have an impact on reproductive performance, even after hysteroscopic adhesiolysis, primary prevention is essential. Expectative and medical management should therefore be considered as serious alternatives for D&C in women with a miscarriage. In case D&C is necessary, application of ACP gel should be considered. Trial registration number Netherlands Trial Register NTR 3120.

scholarly journals Efficiency and efficacy of vitrification in 35 654 sibling oocytes from donation cycles

2020 ◽  
Vol 35 (10) ◽  
pp. 2262-2271
Author(s):  
D Cornet-Bartolomé ◽  
A Rodriguez ◽  
D García ◽  
M Barragán ◽  
R Vassena
Keyword(s):  
Survival Rate ◽  
Embryo Transfer ◽  
Live Birth ◽  
Survival Rates ◽  
High Survival ◽  
Reproductive Outcomes ◽  
Ongoing Pregnancy ◽  
Oocyte Vitrification ◽  
Sibling Oocytes ◽  
Donor Oocytes

Abstract STUDY QUESTION Is oocyte vitrification/warming as efficient and effective as using fresh oocytes in donation cycles? SUMMARY ANSWER IVF with vitrified donor oocytes is less efficient than using fresh oocytes, but its efficacy remains comparable to that of fresh cycles. WHAT IS KNOWN ALREADY Oocyte vitrification is used to preserve the reproductive potential of oocytes. A small number of randomized controlled trials carried out by experienced groups have shown that this technique provides fertilization, pregnancy, implantation and ongoing pregnancy rates comparable to those of fresh oocytes. However, large registry-based analyses have consistently reported lower live birth rates (LBRs) in cycles using vitrified oocytes. It is not clear whether this decrease may be due to the effect of vitrification per se on the oocytes or to the lower efficiency of the technique, as some of the oocytes do not survive after warming. STUDY DESIGN, SIZE, DURATION Retrospective cohort analysis of 1844 cycles of oocyte donation (37 520 oocytes), each donor in the study provided enough oocytes for at least one reception cycle with fresh oocytes (2561 cycles) and one reception cycle with vitrified oocytes (2471 cycles) from the same ovarian stimulation (sibling oocytes). Overall, 35 654 oocytes were considered in the analysis. All embryo transfers (n = 5032) were carried out between 2011 and 2017. PARTICIPANTS/MATERIALS, SETTING, METHODS Differences in reproductive outcomes after the first embryo transfer were evaluated using Pearson’s Chi-squared test and regression analysis adjusted for recipient’s age, BMI, sperm origin and state, day of embryo transfer, morphological score and number of transferred embryos. We performed two additional sub-analyses, to test whether the efficiency and/or effectiveness of vitrification/warming impacts reproductive results. One analysis included paired cycles where the same number of fresh and vitrified oocytes were available for ICSI (SAME sub-analysis), while the second analysis included those cycles with a 100% survival rate post-warming (SAME100 sub-analysis). MAIN RESULTS AND THE ROLE OF CHANCE Baseline and cycle characteristics of participants were comparable between groups. Overall, fertilization rates and embryo morphological scores were significantly lower (P < 0.001) when using vitrified oocytes; moreover, vitrified oocytes also resulted in lower reproductive outcomes than sibling fresh oocytes using both unadjusted and adjusted analyses: ongoing pregnancy (32.1% versus 37.5%; P < 0.001; OR 0.88, 95% CI 0.77, 1.00) and live birth (32.1% versus 31.9%; P = 0.92; OR 1.16, 95% CI 0.90, 1.49). However, when the efficiency of warming was taken into account, reproductive outcomes in recipients became comparable: ongoing pregnancy (33.5% versus 34.1%; P = 0.82; OR 1.11, 95% CI 0.87, 1.43) and LBR (32.1% versus 32%; P = 0.97; OR 1.15, 95% CI 0.89, 1.48). Moreover, after selecting only cycles that, in addition to having the same number of oocytes available for ICSI, also had 100% post-warming survival rate in the vitrified group, reproductive outcomes were also comparable between fresh and vitrified oocytes: ongoing pregnancy (34.8% versus 32.4%; P = 0.42; OR 1.32, 95% CI 0.98, 1.77) and live birth (32.9% versus 31.0%; P = 0.52; OR 1.27, 95% CI 0.95, 1.71), indicating that reproductive outcomes of these cycles are affected by the efficiency of the vitrification/warming technique performed rather than the oocyte damage due to the fast cooling process to which oocytes are subjected. LIMITATIONS, REASONS FOR CAUTION An open vitrification system was used for all cases, and oocyte vitrification/warming was performed by experienced embryologists with consistently high survival rates; caution must be exerted when extrapolating our results to data obtained using other open vitrification systems, closed vitrification systems or to IVF units with survival rates <90%. WIDER IMPLICATIONS OF THE FINDINGS This is the largest cohort study comparing reproductive outcomes of vitrified and fresh sibling donor oocytes to date. We found that, when the number of oocytes available after warming is equal to the number of fresh oocytes, reproductive results including live birth are comparable. Consequently, the efficiency of vitrification must be taken into account to achieve the same reproductive outcomes as with fresh oocytes. We recommend implementing strict indicators of vitrification/warming efficiency in clinics and refining vitrification/warming protocols to maximize survival. STUDY FUNDING/COMPETING INTEREST(S) This work was supported by intramural funding of Clínica EUGIN and by the Secretary for Universities and Research of the Ministry of Economy and Knowledge of the Government of Catalonia (GENCAT 2015 DI 048). The authors declare no conflicts of interest. TRIAL REGISTRATION NUMBER N/A.

scholarly journals Reproductive outcome of a complete septate uterus after hysteroscopic metroplasty

2019 ◽  
Vol 48 (3) ◽  
pp. 030006051989383 ◽  
Author(s):  
Zhenhong Wang ◽  
Jian An ◽  
Yanzhao Su ◽  
Chaobin Liu ◽  
Shunhe Lin ◽  
...  
Keyword(s):  
Live Birth ◽  
Reproductive Performance ◽  
Cumulative Probability ◽  
Reproductive Outcome ◽  
Reproductive Outcomes ◽  
Septate Uterus ◽  
Live Births ◽  
Primary Infertility ◽  
Uterine Septum ◽  
Study Population

Objective This study aimed to evaluate the reproductive outcomes of patients who underwent hysteroscopic metroplasty for correction of a complete septate uterus. Methods The study population comprised 92 women with complete septate uteri. Hysteroscopic metroplasty and laparoscopy were performed simultaneously in these patients. The postoperative reproductive outcome of each patient was evaluated. Results In the primary infertility group, there were 32 (40%) pregnancies. In the abortion group, the number of miscarriages decreased from 68 (94.44%) to 5 (10.42%), while the number of live births increased from 1 (1.39%) to 42 (87.50%) after resection compared with before resection. The cumulative probability of pregnancy and that of live-birth pregnancy in the abortion group were significantly higher than those in the primary infertility group after surgery. Furthermore, resection of the cervical septum resulted in a significantly higher cumulative probability of live birth compared with preservation of the cervical septum. Conclusion Hysteroscopic uterine metroplasty may improve the reproductive performance of a septate uterus. Resection of the cervical septum may increase the probability of a live-birth pregnancy for patients with a cervical septum, and this procedure could be recommended for cases of a complete uterine septum.

scholarly journals Does the effectiveness of IUI in couples with unexplained subfertility depend on their prognosis of natural conception? A replication of the H2Oil study

2020 ◽  
Author(s):  
R van Eekelen ◽  
K Rosielle ◽  
N van Welie ◽  
K Dreyer ◽  
M van Wely ◽  
...  
Keyword(s):  
Study Design ◽  
Research Question ◽  
Secondary Analysis ◽  
Expectant Management ◽  
Ongoing Pregnancy ◽  
Relative Benefit ◽  
Effect Of Treatment ◽  
Natural Conception ◽  
The Absolute

Abstract STUDY QUESTION Can we replicate the finding that the benefit of IUI-ovarian stimulation (IUI-OS) compared to expectant management for couples with unexplained subfertility depends on the prognosis of natural conception? SUMMARY ANSWER The estimated benefit of IUI-OS did not depend on the prognosis of natural conception but did depend on when treatment was started after diagnosis, with starting IUI-OS later yielding a larger absolute and relative benefit of treatment. WHAT IS KNOWN ALREADY IUI-OS is often the first-line treatment for couples with unexplained subfertility. Two randomized controlled trials (RCTs) compared IUI-OS to expectant management using different thresholds for the prognosis of natural conception as inclusion criteria and found different results. In a previous study (a Dutch national cohort), it was found that the benefit of IUI-OS compared to expectant management seemed dependent on the prognosis of natural conception, but this finding warrants replication. STUDY DESIGN, SIZE, DURATION We conducted a secondary analysis of the H2Oil study (n = 1119), a multicentre RCT that evaluated the effect of oil-based contrast versus water-based contrast during hysterosalpingography (HSG). Couples were randomized before HSG and followed up for 3–5 years. We selected couples with unexplained subfertility who received HSG and had follow-up or pregnancy data available. Follow-up was censored at the start of IVF, after the last IUI cycle or at last contact and was truncated at a maximum of 18 months after the fertility workup. PARTICIPANTS/MATERIALS, SETTING, METHODS The endpoint was time to conception leading to an ongoing pregnancy. We used the sequential Cox approach comparing in each month the ongoing pregnancy rates over the next 6 months of couples who started IUI-OS to couples who did not. We calculated the prognosis of natural conception for individual couples, updated this over consecutive failed cycles and evaluated whether prognosis modified the effect of starting IUI-OS. We corrected for known predictors of conception using inverse probability weighting. MAIN RESULTS AND THE ROLE OF CHANCE Data from 975 couples were available. There were 587 couples who received at least one IUI-OS cycle within 18 months after HSG of whom 221 conceived leading to an ongoing pregnancy (rate: 0.74 per couple per year over a median follow-up for IUI of 5 months). The median period between HSG and starting IUI-OS was 4 months. Out of 388 untreated couples, 299 conceived naturally (rate: 0.56 per couple per year over a median follow-up of 4 months). After creating our mimicked trial datasets, starting IUI-OS was associated with a higher chance of ongoing pregnancy by a pooled, overall hazard ratio of 1.50 (95% CI: 1.19–1.89) compared to expectant management. We did not find strong evidence that the effect of treatment was modified by a couple’s prognosis of achieving natural conception (Akaike’s Information Criterion (AIC) decreased by 1 point). The effect of treatment was dependent on when couples started IUI-OS (AIC decreased by more than 2 points). The patterns of estimated absolute chances over time for couples with increasingly better prognoses were different from the previous study but the finding that starting later yields a larger benefit of treatment was similar. We found IUI-OS increased the absolute chance of pregnancy by at least 5% compared to expectant management. The absolute chance of pregnancy after IUI-OS seems less variable between couples and starting times of treatment than the absolute chance after expectant management. LIMITATIONS, REASONS FOR CAUTION This is a secondary analysis, as the H2Oil trial was not designed with this research question in mind. Owing to sample size restrictions, it remained difficult to distinguish between the ranges of prognoses in which true benefit was found. WIDER IMPLICATIONS OF THE FINDINGS We replicated the finding that starting IUI-OS later after diagnosis yields a larger absolute and relative benefit of treatment. We did not replicate the dependency of the effect of IUI-OS on the prognosis of natural conception and could not identify clear thresholds for the prognosis of natural conception when IUI-OS was and/or was not effective. Because many of these couples still have good chances of natural conception at the time of diagnosis, we suggest clinicians should advise couples to delay the start of IUI-OS for several months to avoid unnecessary treatment. STUDY FUNDING/COMPETING INTEREST(S) The H2Oil study (NTR 3270) was an investigator-initiated study that was funded by the two academic institutions (AMC and VUmc) of the Amsterdam UMC. The follow-up study (NTR 6577) was also an investigator-initiated study with funding by Guerbet, France. The funders had no role in study design, collection, analysis and interpretation of the data. B.W.M. is supported by an Investigator grant (GNT1176437) from the Australian National Health and Medical Research Council (NHMRC). K.D. reports receiving travel and speaker fees from Guerbet. B.W.M. reports consultancy for ObsEva, Merck, Merck KGaA, iGenomix and Guerbet. V.M. reports receiving travel- and speaker fees as well as research grants from Guerbet.

scholarly journals Quantitative assessment of pregnancy outcome following recurrent miscarriage clinic care: a prospective cohort study

2021 ◽  
Author(s):  
Rebecca C Shields ◽  
Omar Khan ◽  
Sarah N Lim Choi Keung ◽  
Amelia Hawkes ◽  
Aisling Barry ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cohort Study ◽  
Data Collection ◽  
Pregnancy Outcome ◽  
Live Birth ◽  
Pregnancy Loss ◽  
Recurrent Miscarriage ◽  
Modifiable Risk Factors ◽  
List Type

AbstractObjectivesTo measure pregnancy outcome following attendance at a recurrent miscarriage service and identify factors that influence outcome.DesignProspective, observational electronic cohort study.SettingParticipants attending specialist recurrent miscarriage clinic, within a tertiary centre, with a history of two or more pregnancy losses. The clinic serves a diverse population (33% of residents belong in a minority ethnic group and over 33% in low-income households). Participant data were recorded on a bespoke study database, ‘Tommy’s Net’.Participants777 women consented to participate. 639 (82%) women continued within the cohort, and 138 were lost to follow up. Mean age of active participants was 34 years for women and 37 years for partners, with a mean of 3.5 (1-19) previous pregnancy losses. Rates of obesity, BMI>30 (maternal: 23.8%, paternal: 22.4%), smoking (maternal:7.4%, paternal: 19.4%) and alcohol consumption (maternal: 50%, paternal: 79.2%) were high and 55% of participants were not taking folic acid.Outcome measuresBiannual collection of pregnancy outcomes (ongoing pregnancy, live birth, still birth, pregnancy loss prior to 24 weeks), either through prompted self-reporting, or existing hospital systems.Results639 (82%) women were followed up. 404 reported conception and 106 reported no pregnancy, at least 6 months following registration. Of those that conceived, 72.8% (294/404) had a viable pregnancy. Analysis identified a conception of rate of over 80% and viable pregnancy rate of 60% two years after attending the recurrent miscarriage clinic. 30% of couples had potentially modifiable risk factors for miscarriage.ConclusionsTommy’s Net provides a secure electronic repository on data for couples with recurrent pregnancy loss and associated outcomes. The study identified that subfertility, as well as repeated miscarriage, contributed to failure to achieve live birth. Study findings can enable comparison of clinic management strategies and inform the development of a personalized holistic care package.FunderTommy’s CharitySponsorUniversity Hospitals Coventry and Warwickshire (UHCW) NHS TrustTrial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN) Registry ISRCTN17732518; https://doi.org/10.1186/ISRCTN17732518EthicsApproval from West Midlands-South Birmingham Regional Ethics Committee IRAS No: 213740, 2225751 REC Ref: 17/WM/0050: 17/WM/208Strengths and Limitations of this study (related to the method)The ‘Tommy’s Net’ e-repository and associated database contains baseline and prospective pregnancy outcome data from the largest known population of couples with recurrent miscarriage in the UK.Time to conception and viable pregnancy can be calculated from this data using time to event analysis.Obtaining follow up data is challenging but can be improved by using a variety of data collection methods.Follow up data is only requested biannually, therefore this is an inevitable lag in data collection.Limited use of the English language can be a barrier for participants completing the initial lengthy questionnaire.Key points20% of this recurrent miscarriage population do not conceive and two years after first consultation 40% have not had a viable pregnancy. Early identification of this group could help facilitate early referral to fertility services or targeted research.Miscarriage is physically and psychologically challenging. Some couples may decide not to try to conceive again because of this. Ensuring appropriate psychological support is essential.Preconception care is inadequate. Over one third of couples attend their initial consultation with modifiable risk factors known to impact on miscarriage. Tackling these should be a priority.Having a BMI over 30 and being a smoker is more common within this cohort in women that do not conceive. Targeting of these risk factors may improve conception rate.

Neuroradiology of Brain Stem and Cervicomedullary tumours

1997 ◽  
Vol 10 (1) ◽  
pp. 41-54 ◽  
Author(s):  
C. Colosimo ◽  
T. Tartaglione ◽  
G.M. Di Lella ◽  
A. Cerase
Keyword(s):  
Brain Stem ◽  
Disease Progression ◽  
Classification System ◽  
Precise Definition ◽  
Morphological Data ◽  
Therapeutic Management ◽  
Tumour Site ◽  
Tumour Shrinkage ◽  
Definition Of

Brain stem and cervicomedullary tumours are typical of paediatric age, 80% of them occurring in patients under 18 years of age, and comprising 10–15% of all childhood and adolescent brain tumours, as well as 20–25% of infratentorial locations. They are characteristically pontine tumours (60% of the cases), but they commonly extend to involve the medulla, midbrain and cerebellum. Although most brain stem tumours are low grade gliomas, their prognosis is extremely severe (no more than 20% of patients are alive 3 years after diagnosis and the 5-year survival rate is 5%) because both the typical infiltrating nature and the neuro-anatomical location usually make them surgically unresectable. Surgery is generally limited to biopsy, partial decompression, or excission of the exophytic components, because of the extremely severe functional sequelae of even minor resections. Thus, the mainstay of therapy has been based on irradiation alone or combined with chemotherapy, doses of 5000–5500 cGy being usually adequate for tumour shrinkage or remission, even if recurrence is common after 10–15 months. At present, it is very important to establish reliable, homogeneous, objective, and reproducible diagnostic criteria for the identification of patient subsets with predictable histology, prognosis and possible therapeutic management, in some cases histology, site and relationship of tumour enabling total or subtotal resection with a lower operative risk. Since its introduction, magnetic resonance imaging (MRI) has appeared the procedure of choice for the neuroradiologic study of the brain stem and brain stem tumours, enabling a more precise definition of their margins, a correct assessment of intrinsic and exophytic components, as well as a satisfactory characterization of pathologic tissue. MRI studies should include good quality T1-, PD- and T2-weighted images and T1-weighted images after gadolinium i.v., T2-weighted sagittal images being required for complete evaluation of tumour extent. Computed tomography is still superior in the identification of calcifications and acute intratumoral haemorrhage; it is rapidly performed, thus representing the first choice procedure in emergency, i.e. the diagnosis of hydrocephalus. Epstein has proposed the most widely accepted classification system of brain stem tumours, essentially based on neuroradiological findings, surgical and stereotactic biopsy and histology generally resulting in understaging. This classification system separates intrinsic (diffuse, focal, cervico-medullary), exophytic (anterolateral into cerebellopontine angle, posterolateral into brachium pontis, posterior into fourth ventricle) and cerebrospinal fluid seeding (positive cytology or myelography) tumors. More recently, Barkovich – based on a multicentric study of some of the most important paediatric neurosurgery and neuro-oncology centres of the United States – has clearly defined the neuroradiological parameters which must be considered for an objective and reproducible assessment of brain stem gliomas, in order to identify patient subsets characterized by predictable histology, prognosis and possible therapeutic management. We agree with him, emphasizing that the evaluation of brain stem tumours must include a careful interpretation of all MRI findings (tumour site and origin; dimensions/degree of brain stem enlargement; tumour caudo-cranial and transverse extension; exophytic components; tumour characteristics as defined by MRI signal intensity; cysts, haemorrhage, necrosis, calcifications; ventricular dimensions and hydrocephalus; leptomeninengeal seeding) that can help in the definition of the following tumour subsets: diffuse pontine tumours, medullary tumours, cervicomedullary tumours, focal brain stem tumours. With regard to the neuroradiological follow-up, in patients undergoing surgery (for biopsy decompression or less frequently for radicality), the role of the neuroradiologist is similar to that in other fields of neurosurgery, and concerns the quantitation of the extent of the resection and the identification of possible parenchymal injuries or postoperative haemorrhage, always keeping in mind the negative effects of postoperative reactive phenomena and the blood-brain disruption 24–48 hours to 30–40 days after surgery. However, the major contribution of the neuroradiologist is the objective evaluation of irradiation effects and recently of combined irradiation and chemotherapy. In our experience, the efficacy of irradiation is well evaluated by MRI only 3 or 6 months after the end of treatment, even if a clinical improvement is possible after 30–60 days. However, tumour shrinkage is rarely drastic, and its disappearance, as well as that of signal alterations, is exceptional. Qualitative modifications occurring within the tumour are more difficult to interpret, because of the appearance of cystic or pseudocystic areas, markedly increased enhancement, and small areas of haemorrhage may be related both to irradiation-induced regressive modifications and disease progression. In conclusion, MRI represents the gold standard in the evaluation of brain stem and cervicomedullary tumors, always enabling a precise definition of tumour site and extent, and in most cases the diagnosis of nature, thus allowing the identification of patients who can undergo radical microsurgery. MRI follow-up controls the extent of resection and the effect of combined irradiation and chemotherapy; disease progression is evidenced and spinal seeding can be diagnosed. However, the differentiation between tumour recurrence and irradiation-induced injury may be difficult if only based on morphological data. These limitations of MRI will probably be reduced by the advances in ultra-fast MRI technology and 18F-fluoro-deoxy-glucose positron emission tomography which supplies in vivo metabolic and functional information.

Sign in / Sign up

Export Citation Format

Share Document