scholarly journals A Comparison of the Efficacy of Immediate Versus Delayed Frozen–Thawed Embryo Transfer on the Ongoing Pregnancy Rate After a Failed IVF Attempt: Study Protocol for a Randomized, Non-Inferiority, Parallel-Group, Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Zhuo Liu ◽  
Fengyi Dong ◽  
Yunhan Wang ◽  
Mingming Zheng ◽  
Mengyang Song ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Menstrual Cycle ◽  
Embryo Transfer ◽  
Controlled Trial ◽  
Residual Effects ◽  
Optimal Time ◽  
Ongoing Pregnancy ◽  
Parallel Group ◽  
Frozen Thawed Embryo Transfer ◽  
Thawed Embryo Transfer

IntroductionIn clinical practice, the ideal time at which to perform a Frozen–thawed Embryo Transfer (FET) after a failed In-vitro Fertilization-embryo Transfer (IVF-ET) is still unclear to most practicing physicians. In addition, physicians often delay the introduction of FET due to concerns on the possible residual effects of ovarian hyperstimulation, which may interfere with the regular menstrual cycle. Moreover, given that most of the published studies on the topic are retrospective with contradictory findings, it is crucial to provide evidence-based randomized control guides for clinical practice.Methods/analysisThe study is a randomized, non-inferiority, parallel-group, controlled trial that will enroll a total of 732 women undergoing their first FET after a failed fresh embryo transfer (ET) cycle. The participants will then be randomized into two groups based on a computer-generated randomized list. The two groups include: (i) an immediate group were FET will be carried out during the first menstrual cycle after a failed fresh ET cycle and (ii) a delayed group where FET will be carried out during the second menstrual cycle after a failed fresh ET cycle. Primary outcomes will be defined as viable pregnancies with fetal heartbeats, diagnosed through pelvic ultrasonography after twelve weeks of gestation.Ethics and disseminationThe study was approved by the Ethics Committee of the Assisted Reproductive Medicine at the Affiliated Hospital of Shandong University of Traditional Chinese Medicine (SDTCM/E-2020.2.01). In addition, written informed consent will be obtained from all the participants before the study. The results of this trial will be disseminated in a peer-reviewed journal.DiscussionCurrently, there is no consensus with regard to the duration after which the effects of ovarian stimulation are observed after a failed fresh ET and the optimal time required to begin FET. Moreover, no randomized controlled trial exists that compares the ongoing pregnancy rates after immediate versus delayed FET following a failed fresh ET cycle. Therefore, it is important to conduct a well-designed randomized trial to determine whether it is necessary to delay FET for at least one menstrual cycle after the failure of fresh ET.Clinical Trial RegistrationChiCTR2000033313 (http://www.chictr.org.cn/enIndex.aspx).

scholarly journals P–595 Systematic dydrogesterone supplementation of artificial endometrial preparation cycles for frozen-thawed embryo transfer during Covid–19 pandemic: a good way to limit monitoring visits and optimize outcomes

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
I Cedri. . Durnerin ◽  
M Peigné ◽  
J Labrosse ◽  
M Guerout ◽  
C Vinolas ◽  
...  
Keyword(s):  
Embryo Transfer ◽  
Live Birth ◽  
Endometrial Thickness ◽  
Pregnancy Rates ◽  
Ongoing Pregnancy ◽  
Live Birth Rates ◽  
Endometrial Preparation ◽  
Time Periods ◽  
Frozen Thawed Embryo Transfer ◽  
Thawed Embryo Transfer

Abstract Study question Does systematic dydrogesterone supplementation in artificial cycles (AC) for frozen-thawed embryo transfer (FET) during Covid–19 pandemic modify outcomes compared to prior individualized supplementation adjusted on serum progesterone (P) levels ? Summary answer Systematic dydrogesterone supplementation in AC for FET is associated with similar outcomes compared to prior individualized supplementation in patients with low P levels. What is known already In AC for FET using vaginal P for endometrial preparation, low serum P levels following P administration have been associated with decreased pregnancy and live birth rates. This deleterious effect can be overcome by addition of other routes of P administration. We obtained effective results by adding dydrogesterone to vaginal P and postponing FET by one day in patients with low P levels. However, in order to limit patient monitoring visits and to schedule better FET activity during Covid–19 pandemic, we implemented a systematic dydrogesterone supplementation without luteal P measurement in artificial FET cycles. Study design, size, duration This retrospective study aimed to analyse outcomes of 394 FET after 2 different protocols of artificial endometrial preparation. From September 2019 to Covid–19 lockdown on 15th March 2020, patients had serum P level measured on D1 of vaginal P administration. When P levels were < 11 ng/ml, dydrogesterone supplementation was administered and FET was postponed by one day. From May to December 2020, no P measurement was performed and dydrogesterone supplementation was systematically used. Participants/materials, setting, methods In our university hospital, endometrial preparation was performed using sequential administration of vaginal estradiol until endometrial thickness reached >7 mm, followed by transdermal estradiol combined with 800 mg/day vaginal micronized P started in the evening (D0). Oral dydrogesterone supplementation (30 mg/day) was started concomitantly to vaginal P in all patients during Covid–19 pandemic and only after D1 P measurement followed by one day FET postponement in patients with P levels <11 ng/ml before the lockdown. Main results and the role of chance During the Covid–19 pandemic, 198 FET were performed on D2, D3 or D5 of P administration with dydrogesterone supplementation depending on embryo stage at cryopreservation. Concerning the 196 FET before lockdown, 124 (63%) were performed after dydrogesterone addition from D1 onwards and postponement by one day in patients with serum P levels <11 ng/ml at D1 while 72 were performed in phase following introduction of vaginal P without dydrogesterone supplementation in patients with P > 11 ng/ml. Characteristics of patients in the 2 time periods were similar for age (34.5 + 5 vs 34.1 + 4.8 years), endometrial thickness prior to P introduction (9.9 + 2.1 vs 9.9 + 2.2 mm), number of transferred embryos (1.3 + 0.5 vs 1.4 + 0.5) , embryo transfer stage (D2/D3/blastocyst: 8/16/76% vs 3/18/79%). No significant difference was observed between both time periods [nor between “dydrogesterone addition and postponement by 1 day” and “in phase” FET before lockdown] in terms of positive pregnancy test (39.4% vs 39.3% [44% vs 30.5%]), heartbeat activity at 8 weeks (29.3% vs 28% [29% vs 26.4%]) and ongoing pregnancy rates at 12 weeks (30.7% but truncated at end of October 2020 vs 25.5% [26.6% vs 23.6%]). Limitations, reasons for caution Full results of the Covid–19 period will be further provided concerning ongoing pregnancy rates as well as comparison of live birth rates and obstetrical and neonatal outcomes. Wider implications of the findings: These results suggest that systematic dydrogesterone supplementation is as effective as individualized supplementation according to serum P levels following administration of vaginal P. This strategy enabled us to schedule easier FET and limit patient visits for monitoring while maintaining optimal results for FET in AC during the Covid–19 pandemic. Trial registration number Not applicable

scholarly journals Effect of Intrauterine Administration of Seminal Plasma for Patients with Recurrent Implantation Failure Before FET: Study Protocol for a Prospective Randomised Controlled Trial

2021 ◽  
Author(s):  
ling CUI ◽  
Fang Wang ◽  
Yonghong Lin
Keyword(s):  
Embryo Transfer ◽  
Study Protocol ◽  
Seminal Plasma ◽  
Controlled Trial ◽  
Clinical Pregnancy ◽  
Implantation Failure ◽  
Central Hospital ◽  
Recurrent Implantation Failure ◽  
Frozen Thawed Embryo Transfer ◽  
Thawed Embryo Transfer

Abstract Background: To assess the effect of intrauterine administration of seminal plasma for patients with recurrent implantation failure before frozen-thawed embryo transfer. Methods: Trial design: This is a parallel group, randomized (1:1 allocation ratio) controlled trial.Participants: All patients will be recruited from Chengdu Women’s and Children’s Central Hospital. Inclusion criteria: 1. Women after IVF/ICSI treatment in Chengdu Women’s and Children’s Central Hospital. 2.Infertile women with a history of recurrent implantation failure. 3.Infertile couples (both male and female) aged between 20 and 39 years;4. Couples who have at least 1 good quality embryos for transfer. 5. Males had negative in infectious disease test. 6. The males have semen. 7. Women who intend to undergo FET after IVF or ICSI or pre-implantation genetic testing for aneuploidy (PGT-A). 8. Competent and able to give informed consent. Intervention and comparator: Treatment group receiving intrauterine administration of seminal plasma before frozen-thawed embryo transfer. Main outcomes: Clinical pregnancy after frozen-thawed embryo transfer. Randomisation: Patients will be randomly allocated to either treatment or control group at 1:1 ratio. Random numbers will be generated by using software SPSS 25.0 performed by an independent statistician from Chengdu Women’s and Children’s Central Hospital. Blinding (masking): Only the data analyst will be blinded to group assignment. Numbers to be randomised (sample size): To account for a 10% dropout rate, we will recruit 174 patients (87 in each group). Trial status: The date of approval is 31rd May 2021, version 2.0. Recruitment started on 1rd June and is expected to end in July 2022. Discussion: Intrauterine administration of seminal plasma before frozen-thawed embryo transfer of patients with recurrent implantation failure may improve clinical pregnancy rate, it has great Page 2 of 14 significance for assisted reproduction. Trial registration: The study protocol has been approved by the ethics committees at Chengdu Women’s and Children’s Central Hospital. The trial was registered at the Chinese Clinical Trial Registry ChiCTR2100046803. Registered on 28 May 2021.

scholarly journals The Timing for Initiating Estrogen Stimulation in Artificial Cycle for Frozen-Thawed Embryo Transfer can be Flexible

2021 ◽  
Author(s):  
Ying Ying ◽  
Yixuan Wu ◽  
Shuang Liu ◽  
Qing Huang ◽  
Haiying Liu
Keyword(s):  
Embryo Transfer ◽  
Primary Outcome ◽  
Early Initiation ◽  
Initiation Time ◽  
Ongoing Pregnancy ◽  
Late Initiation ◽  
Estrogen Stimulation ◽  
Frozen Thawed Embryo Transfer ◽  
Artificial Cycle ◽  
Thawed Embryo Transfer

Abstract Background: There remains a lack of evidence to demonstrate whether the initiation time of estrogen stimulation is flexible in the proliferative endometrial phase during the artificial cycle for frozen-thawed embryo transfer (AC-FET).Methods: FET records were retrospectively reviewed from a large university-affiliated reproductive medicine center. Only the patients who were undergoing their first embryo transfer with a single blastocyst in the AC-FET cycles were included: thereby 660 cycles were recruited, and the patients were grouped according to their day of estrogen usage initiation as early initiation group (estrogen stimulation initiated during days 2–5 of menses, n = 128) and the late initiation group (estrogen stimulation initiated on or after the sixth day of menses, n = 532). The primary outcome was the ongoing pregnancy rates (OPR). Results: The rates of biochemical and clinical pregnancies were significantly higher in the late initiation group relative to those in the early initiation group, however, no significant differences were noted between the 2 groups for OPR. Furthermore, after adjusting for the results of the potential confounders, no impact was observed in the initiation time of estrogen stimulation on the OPR.Conclusions: This study provides evidence that initiating the estrogen stimulation on after days 2–5 of menses do not exert adverse effects on the OPR in AC-FETs. Thus, FET can be scheduled in a flexible manner, according to the ovulatory and endometrial statuses and patient and/or clinic preference, without compromising on the clinical outcomes.

P–629 Is spontaneous ovulation better than induced ovulation for frozen-thawed embryo transfer cycle?

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
P K Sim ◽  
P Nadkarni
Keyword(s):  
Pregnancy Rate ◽  
Embryo Transfer ◽  
Clinical Pregnancy ◽  
Clinical Pregnancy Rate ◽  
Ongoing Pregnancy ◽  
Ongoing Pregnancy Rate ◽  
Significance Level ◽  
Induced Ovulation ◽  
Frozen Thawed Embryo Transfer ◽  
Thawed Embryo Transfer

Abstract Study question Between spontaneous ovulation (SPO) and induced ovulation (INO) comparing clinical pregnancy rate and ongoing pregnancy rate for frozen-thawed embryo transfer (FET) cycle, which is better? Summary answer Both spontaneous ovulation and induced ovulation protocols showed no significant difference in clinical pregnancy rates and ongoing pregnancy rates. What is known already Recent practice worldwide is moving towards elective freezing of all embryos and subsequent frozen-thawed transfer, both for a perceived higher pregnancy rate as well as the significant reduction of ovarian hyperstimulation. The timing of FET can be determined by either detecting the spontaneous Luteinizing Hormone surge (SPO group) or by the administration of hCG (INO group). There is still an ongoing debate to determine which is the best protocol for frozen-thawed embryo transfer in the non-hormone replacement therapy (non-HRT) cycle. Study design, size, duration This retrospective study included 500 FET cycles for patients who had regular menses between June 2017 and June 2020. The FET cycles were grouped by type as follows: SPO (n = 281) and INO (n = 219). The primary outcome was the clinical pregnancy rate and the secondary outcome was ongoing pregnancy rate. Ongoing pregnancy is defined as a viable intrauterine pregnancy at 12 weeks of gestation confirmed on an ultrasound scan. Participants/materials, setting, methods This study was conducted in a single IVF centre. Vitrification was used as the cryopreservation method. To standardize outcome measures, only patients having single blastocyst transfer and aged under 38 years old were included. The average age of the patient was 32.9. Gamete donation, embryo donation, pre-implantation testing and assisted hatching cycles were also excluded from the analysis. Categorical data were analysed using Chi-square test SPSS version 25. Main results and the role of chance Clinical pregnancy rate for SPO group was 54.8% (154/281) versus 52.9% (116/219) in INO group. Even though clinical pregnancy rate was higher in SPO group as compared to INO group, it did not reach significance level (ꭓ2 = 0.17, p = 0.68). As all patients had single blastocyst transferred, the implantation rate was the same as clinical pregnancy rate. Ongoing pregnancy rate was also found higher in SPO group as compared to INO group (135/281, 48.0% and 97/219, 44.3% respectively) but again failed to reach significance level (ꭓ2 = 0.70, p = 0.40). Limitations, reasons for caution The retrospective nature of the study and therefore, the analysis was not adjusted for confounding factors such as blastocyst grading, etiology of infertility, and ethnicity of patients. Wider implications of the findings: In natural cycle, both spontaneous ovulation and induced ovulation protocols had the same pregnancy outcomes for frozen-thawed embryo transfer. However, induced ovulation can facilitate in scheduling FET timing to avoid weekends and public holidays, if necessary. Trial registration number Not applicable

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