Comparing live birth rates in two IVF protocols
A Randomized Comparison of the Live Birth Rate Between the Progestin-primed Ovarian Stimulation Protocol and the Gonadotrophin Releasing Hormone Antagonist Protocol in Patients Undergoing in Vitro Fertilization
This study is testing whether a new IVF method using a hormone called progestin can help women under 43 have more successful pregnancies compared to a traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 784 (estimated) |
| Ages | 20 Years to 43 Years |
| Sex | Female |
| Sponsor | ShangHai Ji Ai Genetics & IVF Institute Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT03680053 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the live birth rates between two different protocols used in in vitro fertilization (IVF): the progestin-primed ovarian stimulation protocol and the gonadotrophin releasing hormone antagonist protocol. Infertile women under 43 years of age with a sufficient antral follicle count will be randomly assigned to receive either oral dydrogesterone or subcutaneous Cetrorelix during their ovarian stimulation phase. The primary outcome measured will be the live birth rate following the first frozen embryo transfer. This study seeks to determine if the progestin-primed approach is as effective as the traditional antagonist protocol.
Who should consider this trial
Good fit: Ideal candidates for this study are infertile women under 43 years of age with an antral follicle count of 5 or more.
Not a fit: Patients with functional ovarian cysts, those receiving oocyte donations, or those undergoing preimplantation genetic testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective IVF protocol that improves live birth rates for patients.
How similar studies have performed: Other studies have explored various IVF protocols, but this specific comparison of the progestin-primed and GnRH antagonist protocols is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age of women \<43 years at the time of ovarian stimulation for IVF * Antral follicle count (AFC) on day 2-5 of the period≥5 Exclusion Criteria: * Presence of a functional ovarian cyst with E2\>100 pg/mL * Recipient of oocyte donation * Undergoing preimplantation genetic testing * Presence of hydrosalpinx which is not surgically treated or endometrial polyp on scanning during ovarian stimulation
Where this trial is running
Shanghai
- ShangHai JIAI Genetics&IVF Institute — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xiaoxi Sun, Phd — Shanghai JiAi Genetics & IVF Institute
- Study coordinator: He Li, Md
- Email: lihe198900@163.com
- Phone: +86 13817223099
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.