Cumulative live birth rate of in vitro fertilization cycle via progestin-primed ovarian stimulation versus gonadotropin-releasing hormone antagonist protocol in infertile women with normal ovarian reserve: an open-label, randomized controlled trial

Abstract

This study aimed to evaluate the cumulative live birth rate (cLBR) of progestin-primed ovarian stimulation (PPOS) protocol versus gonadotropin-releasing hormone antagonist (GnRH-ant) protocol for in vitro fertilization (IVF) cycle in infertile women with normal ovarian reserve (NOR). Infertile women with NOR who underwent their first IVF cycle were enrolled in an open-label randomized controlled trial. Patients were randomly assigned 1:1 to receive a freeze-all strategy with delayed embryo transfer (PPOS group, n = 174) and fresh embryo transfer first (GnRH-ant group, n = 174). The primary outcome was the cLBR per aspiration. The cLBR between the PPOS group and GnRH-ant group were comparable (55.75% vs. 52.87%, p = 0.591). A premature luteinizing hormone surge was not observed in the PPOS group, while there were six cases (3.45%) in the GnRH-ant group, but no premature ovulation in either of the groups. The pregnancy outcomes, including implantation rate, clinical pregnancy rate and miscarriage rate, were all comparable. In addition, the number of retrieved oocytes, mature oocytes and viable embryos were similar (all p > 0.05) between the two groups.

Keywords:

• Female infertility
• gonadotropin-releasing hormone antagonist
• in vitro fertilization
• ovarian stimulation
• ovarian reserve
• progestin

Trial registration:

• This trial was registered in the China Clinical Trial Registry on 6 September 2018 (ChiCTR1800018246)

Acknowledgements

We would like to thank all patients and the entire staff of the reproductive centre of Shanghai East Hospital for their support in this trial.

Ethical approval

This work has been carried out in accordance with the Declaration of Helsinki (2000) of the World Medical Association. This study was approved by the Ethics Committee of Shanghai East Hospital (Institutional Review Board number: 2018-17).

Consent form

All patients provided written informed consent to participate in this study.

Author contributions

Lihua Sun, Qiuju Chen, and Hongjuan Ye were the chief investigators who completed the entire study, including procedures, conception, design, and completion. Hongjuan Ye also drafted the manuscript. Liya Shi and Xinxin Quan analysed the data. Min Hou and Zhao Yu were responsible for data collection. Huilan Ma contributed to the follow-up. Songguo Xue was in charge of embryos. All authors approved the final manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

All data generated or analysed during this study are included in this article.

Additional information

Funding

This study was funded by the Natural Science Foundation of Shanghai (No. 18411964000) and the National Natural Science Foundation of China (No. 82101734).