scholarly journals Comparison of PGS2.0 versus conventional embryo morphology evaluation for patients with recurrent pregnancy loss: a study protocol for a multicentre randomised trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e036252
Author(s):  
Caixia Lei ◽  
Yilun Sui ◽  
Jiangfeng Ye ◽  
Yao Lu ◽  
Ji Xi ◽  
...  

IntroductionPregnancy loss (PL) is an adverse life event, and there is no proven effective treatment for recurrent PL (RPL). Preimplantation genetic screening (PGS) can be performed to reduce the risks of PL; however, there is still no solid scientific evidence that PGS improves outcomes for couples experiencing RPL. Comprehensive chromosome screening (PGS2.0) has become a routine practice in in vitro fertilisation (IVF) clinics. Previous studies based on PGS1.0 with a focus on RPL couples where the female is of advanced maternal age have reported contradictory results. Hence, a multicentre randomised trial is needed to provide evidence for the clinical benefits of PGS2.0 treatment for RPL couples.Methods and analysisOverall, 268 RPL couples undergoing IVF cycles will be enrolled. Couples will be randomised according to a unique grouping number generated by a random digital software into (1) PGS2.0 group and (2) non-PGS (conventional embryo morphology evaluation) group. This study aims to investigate whether the live birth rate (LBR) per initiated cycle after PGS2.0 is superior to the LBR per initiated cycle after conventional embryo evaluation (non-PGS group). Live birth will be defined as a live baby born after a gestation period of >28 weeks, with a birth weight of more than 1000 g. A multivariate logistic regression model will be used to adjust for confounding factors.Ethics and disseminationEthical approval has been granted by the Ethics Committee of Obstetrics and Gynecology Hospital, Fudan University and the participating hospitals. Written informed consent will be obtained from each couple before any study procedure is performed. Data from this study will be stored in the Research Electronic Data Capture. The results of this trial will be presented and published via peer-reviewed publications and presentations at international conferences.Trial registration numberNCT03214185; Pre-results.

2019 ◽  
Vol 58 (4) ◽  
pp. 173-178
Author(s):  
Milan Reljič ◽  
Vida Gavrić Lovrec

Abstract Background The aim of the study was to determine predictive factors for live birth after in vitro fertilization with autologous oocytes in women ≥40 years of age. Methods Authors conducted a retrospective analysis of in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycles performed at the Department of Reproductive Medicine and Gynecologic Endocrinology, University Medical Centre Maribor, Slovenia between January 2006 and December 2015 in women aged 40 or more. The characteristics of patients and cycles were compared regarding live birth as the final outcome. Results A total of 1920 IVF/ICSI cycles with egg retrieval in women ≥40 years of age were performed leading to 1591 embryo transfers. The live birth rate per embryo transfer was 17.3% at 40, 11.6% at 41, 8.2% at 42, 7.9% at 43, 1.9% at 44 and 0.0% at ≥45 years of age. The multivariate logistic regression model showed that besides women’s age (OR 0.66, 95% CI: 0.55–0.78), the number of previous cycles (OR 0.88, 95% CI: 0.82–0.95), number of good quality embryos on day 2 (OR 1.19, 95% CI: 1.05-1.36), number of embryos transferred (OR 1.57, 95% CI: 1.19–2.07) and day 5 embryo transfer (OR 2.21, 95% CI: 1.37–3.55) were also independent prognostic factors for live birth. Conclusions The chance of in vitro fertilization success in women ≥40 years of age should not be estimated only on the woman’s age, but also on other predictive factors: number of previous cycles, number of good quality embryos on day 2, number of transferred embryos and blastocyst embry transfer.


BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034194
Author(s):  
Mohamed Fawzy ◽  
Mai Emad ◽  
Jack Wilkinson ◽  
Ragaa Mansour ◽  
Ali Mahran ◽  
...  

IntroductionOne potential stressor that can affect preimplantation and postimplantation embryonic growth after in vitro fertilisation (IVF) is the pH of the human embryo culture medium, but no evidence exists to indicate which pH level is optimal for IVF. Based on anecdotal evidence or mouse models, culture media manufacturers recommend a pH range of 7.2 to 7.4, and IVF laboratories routinely use a pH range of 7.25 to 7.3. Given the lack of randomised trials evaluating the effect of pH on live birth rate after IVF, this trial examines the effect of three different pH levels on the live birth rate.Methods and analysisThis multicentre randomised trial will involve centres specialised in IVF in Egypt. Eligible couples for intracytoplasmic sperm injection (ICSI) will be randomised for embryo culture at pH 7.2, 7.3 or 7.4. The study is designed to detect 10 percentage points difference in live birth rate between the best and worst performing media with 93% power at a 1% significance level. The primary outcome is the rate of live birth (delivery of one or more viable infants beyond the 20th week of gestation) after ICSI. Secondary clinical outcomes include biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, preterm births, birth weight, stillbirth, congenital malformation and cumulative live birth (within 1 year from randomisation). Embryo development outcomes include fertilisation, blastocyst formation and quality, and embryo cryopreservation and utilisation.Ethics and disseminationThe study was reviewed and approved by the Ethics Review Boards of the participating centres. Eligible women will sign a written informed consent before enrolment. This study has an independent data monitoring and safety committee comprised international experts in trial design and in vitro culture. No plan exists to disseminate results to participants or health communities, except for the independent monitoring and safety committee of the trial.Trial registration numberNCT02896777.


2020 ◽  
Vol 47 (2) ◽  
pp. 135-139
Author(s):  
Se Jeong Kim ◽  
Dayong Lee ◽  
Seul Ki Kim ◽  
Byung Chul Jee ◽  
Seok Hyun Kim

Objective: In the present study, we aimed to retrospectively evaluate the cumulative live birth rate (LBR) after up to three consecutive embryo transfer (ET) cycles, either fresh or frozen, in women with expected poor ovarian response (ePOR). Methods: We selected 115 women who entered the first <i>in vitro</i> fertilization (IVF) cycle between August 2013 and July 2016. The women were divided into an ePOR group (37 women) and a non-ePOR group (78 women). All women in the ePOR group were ≥40 years old or had serum anti-Müllerian hormone levels of less than 1.1 ng/mL at the time of the first IVF cycle. Live birth outcomes were monitored until December 2017. The cumulative LBR (with both conservative and optimistic estimates) was calculated according to the serial number of ET cycles. Results: After up to three ET cycles, the overall cumulative LBR was significantly lower in the ePOR group than in the non-ePOR group (conservative estimate, 10.8% vs. 44.9%, respectively; optimistic estimate, 14.7% vs. 56.1%, respectively; log-rank test, <i>p</i>=0.003). Conclusion: Women with ePOR exhibited a lower cumulative LBR than women in the non-ePOR group, and this information should be provided to ePOR women during counseling before starting IVF.


2020 ◽  
Author(s):  
Xiaoyan Ding ◽  
Jingwei Yang ◽  
Lan Li ◽  
Na Yang ◽  
Ling Lan ◽  
...  

Abstract Background: Along with progress in embryo cryopreservation, especially in vitrification has made freeze all strategy more acceptable. Some studies found comparable or higher live birth rate with frozen embryo transfer (FET) than with fresh embryo transfer(ET)in gonadotropin releasing hormone antagonist (GnRH-ant) protocol. But there were no reports about live birth rate differences between fresh ET and FET with gonadotropin releasing hormone agonist (GnRH-a) long protocol. The aim of this study is to analyze whether patients benefit from freeze all strategy in GnRH-a protocol from real-world data.Methods: This is a retrospective cohort study, in which women undergoing fresh ET or FET with GnRH-a long protocol at Chongqing Reproductive and Genetics Institute from January 2016 to December 2018 were evaluated. The primary outcome was live birth rate. The secondary outcomes were implantation rate, clinical pregnancy rate, pregnancy loss and ectopic pregnancy rate.Results: A total of 7,814 patients met inclusion criteria, implementing 5,216 fresh ET cycles and 2,598 FET cycles, respectively. The demographic characteristics of the patients were significantly different between two groups, except BMI. After controlling for a broad range of potential confounders (including age, infertility duration, BMI, AMH, no. of oocytes retrieved and no. of available embryos), multivariate logistic regression analysis demonstrated that there was no significant difference in terms of clinical pregnancy rate, ectopic pregnancy rate and pregnancy loss rate between two groups (all P>0.05). However, the implantation rate and live birth rate of fresh ET group were significantly higher than FET group (P<0.001 and P=0.012, respectively).Conclusion: Compared to FET, fresh ET following GnRH-a long protocol could lead to higher implantation rate and live birth rate in infertile patients underwent in vitro fertilization (IVF). The freeze all strategy should be individualized and made with caution especially with GnRH-a long protocol.


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