scholarly journals Does serum progesterone level impact the ongoing pregnancy rate in frozen embryo transfer under artificial preparation with vaginal progesterone? Study protocol for a randomized controlled trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Lin Haiyan ◽  
Yang Gang ◽  
Li Yu ◽  
Li Lin ◽  
Chen Xiaoli ◽  
...  
Keyword(s):  
Embryo Transfer ◽  
Clinical Pregnancy ◽  
Frozen Embryo Transfer ◽  
Progesterone Level ◽  
Sufficient Evidence ◽  
Ongoing Pregnancy ◽  
Serum Progesterone ◽  
Randomized Controlled ◽  
Link Type ◽  
Low Serum

Abstract Background In previous retrospective studies, low serum progesterone level on the embryo transfer day is associated with lower clinical pregnancy and ongoing pregnancy rates. Whether adding progesterone in low serum progesterone patients can rescue the outcome, there is no sufficient evidence from randomized controlled studies. Methods This trial is a clinical randomized controlled study (high serum progesterone vs low serum progesterone 1:1, 1:1 randomization ratio of intervention vs the control group with low serum progesterone). The eligible hormone replacement therapy—frozen embryo transfer (HRT-FET) cycles, will be recruited and randomly assigned to two parallel groups when serum progesterone is < 7.24μg/l on the day of embryo transfer for D3. The intervention group will be extrally given intramuscular progesterone 40 mg per day from D3 to 8 weeks of gestation if clinical pregnancy. The primary outcome is the ongoing pregnancy (beyond 12 weeks of gestation) rate. Discussion The findings of this study will provide strong evidence for whether the progesterone addition from the D3 in low serum progesterone patients can improve the outcome in the HRT-FET cycle. Trial registration ClinicalTrials.govNCT04248309. Registered on January 28, 2020

P–404 Low serum progesterone on the day of frozen blastocyst transfer is associated with a diminished ongoing pregnancy rate in hormonal replacement therapy cycles

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
C Maignien ◽  
B Mathilde ◽  
B Valérie ◽  
C Ahmed ◽  
C Charles ◽  
...  
Keyword(s):  
Replacement Therapy ◽  
Pregnancy Rate ◽  
Embryo Transfer ◽  
Frozen Embryo Transfer ◽  
Blastocyst Transfer ◽  
Progesterone Level ◽  
Ongoing Pregnancy ◽  
Ongoing Pregnancy Rate ◽  
Serum Progesterone ◽  
Hormonal Replacement

Abstract Study question Is there a relationship between progesterone levels on the day of frozen blastocyst transfer and ongoing pregnancy rate (OPR), in hormonal replacement therapy (HRT) cycles? Summary answer Women undergoing HRT-frozen embryo transfer with progesterone levels≤9.76ng/ml on the day of blastocyst transfer had a significantly lower OPR than those with progesterone levels&gt;9.76 ng/ml. What is known already The importance of serum progesterone levels around the time of frozen embryo transfer (FET) is a burning issue, in view of the growing number of FET worldwide. However, the optimal range of serum progesterone levels is not clearly determined and discrepancies arise from the current literature. Study design, size, duration: Observational cohort study with 915 patients undergoing HRT-FET at a tertiary care university hospital, between January 2019 and March 2020. Participants/materials, setting, methods Patients undergoing single autologous blastocyst FET under HRT using exogenous estradiol and vaginal micronized progesterone for endometrial preparation. Women were only included once during the study period. The serum progesterone level was measured in the morning of the FET, in a single laboratory. The primary endpoint was OPR beyond pregnancy week 12. Statistical analysis was conducted using univariate and multivariate logistic regression models. Main results and the role of chance Mean serum progesterone level on the day of FET was 12.90 ± 4.89 ng/ml). The OPR was 35.5% (325/915) in the overall population. Patients with a progesterone level ≤ 25th percentile (≤9.76ng/ml) had a significantly lower OPR and a higher miscarriage rate (MR) compared with women with progesterone level over Centile 25 (29.6% versus 37.4%; p = 0.033 and 34.8% versus 21.3%; p = 0.008, respectively). After adjustment for the potential confounders in a multivariate analysis, a serum progesterone level ≤ 9.76 ng/ml on the day of FETand FET of a Day 6-blastocyst (versus Day 5-blastocyst) were found as independent risks factor of lower OPR. Limitations, reasons for caution The main limitation of our study is linked to its observational design. Extrapolation of our results to other laboratories, or other routes and/or doses of administering progesterone also needs to be validated. Wider implications of the findings: This study suggests that a minimum serum progesterone level is needed to optimize reproductive outcomes in autologous blastocyst FET, in HRT-cycles. Further studies are needed to evaluate if modifications of progesterone routes and/or doses may improve pregnancy chances, in an approach to individualize the management of ART patients. Trial registration number NA

scholarly journals Strengthened luteal phase support for patients with low serum progesterone on the day of frozen embryo transfer in artificial endometrial preparation cycles: a large-sample retrospective trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Hongyuan Gao ◽  
Jing Ye ◽  
Hongjuan Ye ◽  
Qingqing Hong ◽  
Lihua Sun ◽  
...  
Keyword(s):  
Embryo Transfer ◽  
Luteal Phase ◽  
Birth Rate ◽  
Live Birth Rate ◽  
Clinical Pregnancy ◽  
Frozen Embryo Transfer ◽  
Serum Progesterone ◽  
Group A ◽  
Group B ◽  
Low Serum

Abstract Background Low serum progesterone on the day of frozen embryo transfer (FET) is associated with diminished pregnancy rates in artificial endometrium preparation cycles, but there is no consensus on whether strengthened luteal phase support (LPS) benefits patients with low progesterone on the FET day in artificial cycles. This single-centre, large-sample retrospective trial was designed to investigate the contribution of strengthened LPS to pregnancy outcomes for groups with low progesterone levels on the FET day in artificial endometrium preparation cycles. Methods Women who had undergone the first artificial endometrium preparation cycle after a freeze-all protocol in our clinic from 2016 to 2018 were classified into two groups depending on their serum progesterone levels on the FET day. Routine LPS was administered to group B (P ≥ 10.0 ng/ml on the FET day, n = 1261), and strengthened LPS (routine LPS+ im P 40 mg daily) was administered to group A (P < 10.0 ng/ml on the FET day, n = 1295). The primary endpoint was the live birth rate, and the secondary endpoints were clinical pregnancy, miscarriage and neonatal outcomes. Results The results showed that the clinical pregnancy rate was significantly lower in group A than in group B (48.4% vs 53.2%, adjusted risk ratio (aRR) 0.81, 95% confidence interval (CI) 0.68, 0.96), whereas miscarriage rates were similar between the two groups (16.0% vs 14.7%, aRR 1.09, 95% CI 0.77, 1.54). The live birth rate was slightly lower in group A than in group B (39.5% vs 43.3%, aRR 0.84, 95% CI 0.70, 1.0). Birthweights and other neonatal outcomes were similar between the two groups (P > 0.05). Conclusions The results indicated that the serum progesterone level on the FET day was one of the risk factors predicting the chances of pregnancy in artificial endometrium preparation cycles, and strengthened LPS in patients with low progesterone on the FET day might help to provide a reasonable pregnancy outcome in artificial cycles, although further prospective evidence is needed to confirm this possibility.

P–605 Low serum progesterone on the day of frozen embryo transfer after artificial endometrial preparation: exploring the clinical impact of “rescue” strategies

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
A Herencia ◽  
J Llácer ◽  
J A Ortiz ◽  
J C Castillo ◽  
C Gavilán ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Embryo Transfer ◽  
Pregnancy Rates ◽  
Frozen Embryo Transfer ◽  
Control Group ◽  
Ongoing Pregnancy ◽  
Serum Progesterone ◽  
Endometrial Preparation ◽  
Vaginal Progesterone ◽  
Low Serum

Abstract Study question Can we rescue treatments with low progesterone (PG) levels the day of frozen embryo transfer (FET) by adding subcutaneous progesterone? Summary answer After receiving additional supplementation with subcutaneous progesterone, women with low serum progesterone on cryotransfer day, have similar ongoing pregnancy rates as women with normal levels. What is known already Micronized vaginal progesterone fails to achieve optimal serum levels in up to 30% of patients receiving frozen embryos under artificial cycles (AC) despite the administration of 400 mg twice daily. Cancelling the thawing process and restarting a new treatment is a very disappointing option for patients and doctors. An alternative strategy is to administrate additional progesterone subcutaneously. The efficacy of the additional administration of subcutaneous progesterone as a “rescue” strategy in terms of clinical outcomes remains to be validated. Study design, size, duration We included 356 FET performed at Instituto Bernabeu between January 2019 - August 2020 in a retrospective case-control study. Groups were established according to PG levels on the day of the embryo transfer. The Control Group included: patients with optimal progesterone levels (≥8.8 ng ml); while the Rescue Group included those with suboptimal progesterone levels (&lt;8.8 ng ml). Participants/materials, setting, methods All patients performed frozen embryo transfer after artificial endometrial preparation. All embryo transfers were performed at blastocyst stage after 5 days of progesterone administration. Progesterone levels were assessed the day of the embryo transfer by an electrochemiluminescence immunoassay. Samples were obtained 2–5 hours after the last vaginal progesterone administration. Primary outcome was Ongoing Pregnancy Rates (OPR). Secondary outcomes were pregnancy rates (PR), miscarriage rates (MR) and biochemical miscarriage (BM). Main results and the role of chance 301 patients were included in the Control Group and 55 in the Rescue Group. No significant differences were found between both groups. OPR rate was 34.7% for patients in the control group versus 26.4% in the rescue group (p = 0.240) PR was 52.5% for patients with optimal PG levels vs 54.5% when PG levels were below 8.8 ng/mL. Both BM and MR tend to be higher in women who had low serum PG: BM (21.4% vs 15.5%) and MR (28.6% vs 18.1%), without reaching significant statistical difference. In addition, we analyzed data from a sub-group of patients who received extra subcutaneous progesterone (based on cliniciańs decision), despite having normal serum PG levels. No differences in clinical outcomes between these groups were observed either. OPR was 29%, vs 35.4% (p = 0.241), PR was 51.8% vs 53.7%; BM was 16.7% vs 16.3% and MR was 26.9% vs 17.1% between women who received an extra subcutaneous PG dose versus women who did not, respectively. Weight and BMI distribution were homogeneous across groups. A discreet difference was observed in age distribution (control group mean age 41.6 years vs. 39.7 years in the rescue group). Limitations, reasons for caution The retrospective collection of data and a limited sample size constitutes the main limitations of the study. Significant statistical differences were not found between groups but still differences might be clinically relevant. Larger studies are needed to reach robust conclusions on the strategy. Wider implications of the findings: In AC cycles, when supplemented with additional subcutaneous progesterone, women showing low serum progesterone on cryotransfer day may expect similar clinical outcomes as women with normal levels. Pending on confirmatory studies, this strategy could consider as an alternative to cycle cancellation. Trial registration number Not applicable

Individualised luteal phase support in artificially prepared frozen embryo transfer cycles based on serum progesterone levels: a prospective cohort study

2021 ◽  
Author(s):  
Manuel Álvarez ◽  
Sofía Gaggiotti-Marre ◽  
Francisca Martínez ◽  
Lluc Coll ◽  
Sandra García ◽  
...  
Keyword(s):  
Pregnancy Rate ◽  
Embryo Transfer ◽  
Pregnancy Outcomes ◽  
Luteal Phase ◽  
Frozen Embryo Transfer ◽  
Ongoing Pregnancy ◽  
Serum Progesterone ◽  
Endometrial Preparation ◽  
Group 2 ◽  
Group 1

Abstract STUDY QUESTION Does an individualised luteal phase support (iLPS), according to serum progesterone (P4) level the day prior to euploid frozen embryo transfer (FET), improve pregnancy outcomes when started on the day previous to embryo transfer? SUMMARY ANSWER Patients with low serum P4 the day prior to euploid FET can benefit from the addition of daily subcutaneous P4 injections (Psc), when started the day prior to FET, and achieve similar reproductive outcomes compared to those with initial adequate P4 levels. WHAT IS KNOWN ALREADY The ratio between FET/IVF has spectacularly increased in the last years mainly thanks to the pursuit of an ovarian hyperstimulation syndrome free clinic and the development of preimplantation genetic testing (PGT). There is currently a big concern regarding the endometrial preparation for FET, especially in relation to serum P4 levels around the time of embryo transfer. Several studies have described impaired pregnancy outcomes in those patients with low P4 levels around the time of FET, considering 10 ng/ml as one of the most accepted reference values. To date, no prospective study has been designed to compare the reproductive outcomes between patients with adequate P4 the day previous to euploid FET and those with low, but restored P4 levels on the transfer day after iLPS through daily Psc started on the day previous to FET. STUDY DESIGN, SIZE, DURATION A prospective observational study was conducted at a university-affiliated fertility centre between November 2018 and January 2020 in patients undergoing PGT for aneuploidies (PGT-A) IVF cycles and a subsequent FET under hormone replacement treatment (HRT). A total of 574 cycles (453 patients) were analysed: 348 cycles (leading to 342 euploid FET) with adequate P4 on the day previous to FET, and 226 cycles (leading to 220 euploid FET) under iLPS after low P4 on the previous day to FET, but restored P4 levels on the transfer day. PARTICIPANTS/MATERIALS, SETTING, METHODS Overall we included 574 HRT FET cycles (453 patients). Standard HRT was used for endometrial preparation. P4 levels were measured the day previous to euploid FET. P4 &gt; 10.6 ng/ml was considered as adequate and euploid FET was performed on the following day (FET Group 1). P4 &lt; 10.6 ng/ml was considered as low, iLPS was added in the form of daily Psc injections, and a new P4 analysis was performed on the following day. FET was only performed on the same day when a restored P4 &gt; 10.6 ng/ml was achieved (98.2% of cases) (FET Group 2). MAIN RESULTS AND THE ROLE OF CHANCE Patient’s demographics and cycle parameters were comparable between both euploid FET groups (FET Group 1 and FET Group 2) in terms of age, weight, oestradiol and P4 levels and number of embryos transferred. No statistically significant differences were found in terms of clinical pregnancy rate (56.4% vs 59.1%: rate difference (RD) −2.7%, 95% CI [−11.4; 6.0]), ongoing pregnancy rate (49.4% vs 53.6%: RD −4.2%, 95% CI [−13.1; 4.7]) or live birth rate (49.1% vs 52.3%: RD −3.2%, 95% CI [−12; 5.7]). No significant differences were also found according to miscarriage rate (12.4% vs 9.2%: RD 3.2%, 95% CI [−4.3; 10.7]). LIMITATIONS, REASONS FOR CAUTION Only iLPS through daily Psc was evaluated. The time for Psc injection was not stated and no serum P4 determinations were performed once the pregnancy was achieved. WIDER IMPLICATIONS OF THE FINDINGS Our study provides information regarding an ‘opportunity window’ for improved ongoing pregnancy rates and miscarriage rates through a daily Psc injection in cases of inadequate P4 levels the day previous to FET (P4 &lt; 10.6 ng/ml) and restored values the day of FET (P4 &gt; 10.6 ng/ml). Only euploid FET under HRT were considered, avoiding one of the main reasons of miscarriage and implantation failure and overcoming confounding factors such as female age, embryo quality or ovarian stimulation protocols. STUDY FUNDING/COMPETING INTEREST(S) No external funding was received. B.C. reports personal fees from MSD, Merck Serono, Ferring Pharmaceuticals, IBSA and Gedeon Richter outside the submitted work. N.P. reports grants and personal fees from MSD, Merck Serono, Ferring Pharmaceuticals, Theramex and Besins International and personal fees from IBSA and Gedeon Richter outside the submitted work. The remaining authors have no conflicts of interest to declare. TRIAL REGISTRATION NUMBER NCT03740568.

scholarly journals EVALUATION OF CORRELATION OF SERUM PROGESTERONE LEVEL WITH PREGNANCY OCCURRENCE IN FROZEN EMBRYO TRANSFER

2018 ◽  
Vol 7 (38) ◽  
pp. 4245-4248
Author(s):  
Leila Zarei ◽  
Tahereh Behroozilak ◽  
Masoumeh Hajshafiyiha ◽  
Roya Azizzadeh ◽  
Aelham Talebi ◽  
...  
Keyword(s):  
Embryo Transfer ◽  
Frozen Embryo Transfer ◽  
Progesterone Level ◽  
Serum Progesterone

scholarly journals Comparison of Serum Progesterone Levels of the Day of Frozen Embryo Transfers According to Type of Endometrial Preparation: A Monocentric, Retrospective Study

2020 ◽  
Author(s):  
Olivier Pouget ◽  
Irma Zuna ◽  
Marine Bonneau ◽  
Marie Laure Tailland ◽  
Sylvie Neveu-Ripart ◽  
...  
Keyword(s):  
Embryo Transfer ◽  
Pregnancy Loss ◽  
Loss Rate ◽  
Preparation Method ◽  
Endometrial Thickness ◽  
Clinical Pregnancy ◽  
Progesterone Level ◽  
Serum Progesterone ◽  
Endometrial Preparation ◽  
Artificial Cycle

Abstract Background: Live birth rate following embryo transfer is comparable between natural cycle and hormonal therapy. However, pregnancy loss rate appears elevated with hormonal therapy, possibly due to luteal insufficiency, characterised by a low level of serum progesterone in the luteal phase. The primary objective of this study, was to determine whether serum progesterone level on transfer day differed according to endometrial preparation method in patients undergoing frozen embryo transfer (FET). Secondary objectives were to compare the clinical pregnancy with foetal heartbeat rate and pregnancy loss rate according to endometrial preparation method and to compare the level of serum progesterone on the transfer day between pregnancy loss and pregnancy with foetal heartbeat.Methods: Forty-seven natural/stimulated cycles and 68 artificial cycle FET were retrospectively studied from May to December 2019 from a single French hospital. The primary endpoint was the level of serum progesterone on the day of FET. The type of infertility, aetiology, serum basal FSH, LH, oestradiol and AMH dosage, endometrial thickness, clinical pregnancy rate, pregnancy loss rate, and maternal and embryo characteristics were compared between natural/stimulated cycle (OS group) and artificial cycle (AC group). Results: Mean serum progesterone level on embryo transfer day was 25.47 ng/mL in the OS group versus 14.32 ng/mL AC group (p <0.0001). There was no significant difference in demographic and hormone characteristics (age, type of embryo, type of infertility, basal FSH, LH, oestradiol and AMH levels), endometrial thickness, number and type of embryos transferred, duration of infertility, pregnancy rate and pregnancy loss rate. Body mass index was lower in the OS group than AC group (22.9 kg/m2 vs 24.8 kg/m2, p=0.03). No difference was found in serum progesterone level between clinical pregnancy with foetal heartbeat and pregnancy loss (respectively 17.48 ng/mL vs 20.82 ng/mL, p=0.7 and 22 ongoing pregnancies and 12 pregnancy loss).Conclusions: Serum progesterone level on FET day is lower with endometrial preparation with artificial cycle than with a natural/stimulated cycle. Further research is necessary to determine if this difference has any relation with higher pregnancy loss rate with artificial cycle.

scholarly journals Pregnancy Outcomes of Patients with Low Serum β-hCG Level 14 Days After Fresh Embryo Transfer

2020 ◽  
Author(s):  
Yixuan Wu ◽  
Haiying Liu
Keyword(s):  
Embryo Transfer ◽  
Pregnancy Outcomes ◽  
Roc Curves ◽  
Clinical Pregnancy ◽  
Ongoing Pregnancy ◽  
Fresh Embryo Transfer ◽  
Biochemical Pregnancy ◽  
Β Hcg ◽  
Low Serum ◽  
Day 3 Embryo

Abstract Background: Although previous studies had successfully illustrated different pregnancy outcomes by different serum β-hCG levels after embryo transfer, prognosis of pregnancy outcomes remains elusive when the serum β-hCG level is extremely low (e.g., < 100 mIU/ml 14 days after embryo transfer). Therefore, the purpose of our study is to investigate the pregnancy outcomes of patients with low serum β-hCG level 14 days after day 3 embryo transfer. Methods: A retrospective study was performed with 723 patients with a serum β-hCG level between 5 and 100 mIU/ml 14 days after day 3 fresh embryo transfer. Pregnancy outcomes (ongoing pregnancy, early miscarriage, biochemical pregnancy loss, and ectopic pregnancy) were analyzed according to the female patients’ age. Receiver operating characteristic (ROC) curves were plotted to indicate the threshold for prediction of clinical pregnancy and ongoing pregnancy. Sensitivity and specificity were calculated according the ROC curves as well. Results: Of the 723 patients with serum β-hCG level <100 mIU/mL 14 days after day 3 embryo transfer, 85.6% (619) had biochemical pregnancy, and only 14.4% (104) had clinical pregnancy (including 4.7% with ongoing pregnancy, 3.7% with ectopic pregnancy, and 5.9% with early miscarriage). The rate of ongoing pregnancy was significantly lower in ≥ 38-year group compared with < 38-year group (1.3% vs. 5.6%, P =0.029). The serum β-hCG level to predict clinical pregnancy was 44.7 mIU/ml (sensitivity, 91.3%; specificity, 82.1%; area under the ROC curve (AUROC), 0.908). For ongoing pregnancy, the serum β-hCG level was 53.7 mIU/ml (sensitivity, 94.1%; specificity, 81.4%; AUROC, 0.902). Conclusions: Initially low serum β-hCG level 14 days after day 3 embryo transfer indicated poor prognosis with minimal likelihood of ongoing pregnancy. Keywords: assisted reproductive technology; human chorionic gonadotropin; pregnancy; live birth; embryo transfer

Progesterone levels on the human chorionic gonadotropin trigger day affect the pregnancy rates for embryos transferred at different stages of development in both general and selected IVF/ICSI populations

2020 ◽  
Author(s):  
Philippe Merviel ◽  
Sarah Bouée ◽  
Anne-Solenn Jacamon ◽  
Jean-Jacques Chabaud ◽  
Marie-Thérèse Le Martelot ◽  
...  
Keyword(s):  
General Population ◽  
Pregnancy Rate ◽  
Embryo Transfer ◽  
Predictive Factors ◽  
Pregnancy Rates ◽  
Clinical Pregnancy ◽  
Clinical Pregnancy Rate ◽  
Blastocyst Transfer ◽  
Progesterone Level ◽  
Serum Progesterone

Abstract Background Two meta-analyses have shown that pregnancy and birth rates are significantly higher after blastocyst transfer than after cleaved embryo transfer. Other studies have revealed that a serum progesterone level > 1.5 ng/ml on the trigger day is responsible for premature luteinization and is associated with a low pregnancy rate. The objectives of the present study were to determine whether blastocyst transfer gave higher pregnancy rates than cleaved embryo transfer at day 3 in both the general and selected IVF/ICSI populations, and whether the serum progesterone level influenced the pregnancy rate. Method : We studied IVF/ICSI cycles with GnRH antagonist - FSH/hMG protocols in a general population (n = 1210) and a selected “top cycle” population (n = 677), after blastocyst transfer on D5 or cleaved embryo transfer on D3. The selected cycles had to meet the following criteria: female age < 35, first or second cycle, and one or two embryos transferred. We recorded predictive factors for pregnancy and calculated the serum progesterone to oocyte ratio (P/Ooc), the serum progesterone to serum estradiol ratio (P/E2), and the serum progesterone to follicle (> 14 mm) index (PFI). Results In the general population, the clinical pregnancy rate was significantly higher after blastocyst transfer (33.3%) than after cleaved embryo transfer (25.3%; p < 0.01). The differences between blastocyst and embryo transfer groups were not significant in the selected population (respectively 35.7% vs. 35.8% for the clinical pregnancy rate). The only predictive factors common to the general and selected populations were the serum progesterone levels on the eve of the trigger day and on the day itself, which were significantly lower in the subgroups of women who became pregnant (p < 0.01). We found a serum progesterone threshold of 0.9 ng/ml, as also reported by other studies. The P/Ooc ratio and the PFI appear to have predictive value for cleaved embryos transfers. Conclusions Blastocyst transfers were associated with higher clinical pregnancy rate than cleaved embryo transfers in a general population but not in a selected population. The serum progesterone levels on the eve of the trigger day and on the day itself predicted the likelihood of pregnancy.

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