Comparing two protocols for embryo development in IVF patients
A Randomized Control Trial to Compare the Euploid Rate of Blastocyst Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients Undergoing PGT-A
PHASE3 · ShangHai Ji Ai Genetics & IVF Institute · NCT04414748
This study is testing which of two different IVF treatment plans helps infertile women create more healthy embryos for pregnancy.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 20 Years to 43 Years |
| Sex | Female |
| Sponsor | ShangHai Ji Ai Genetics & IVF Institute (other) |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04414748 on ClinicalTrials.gov |
What this trial studies
This randomized trial compares the euploid rate of blastocysts between two ovarian stimulation protocols: Progestin-primed Ovarian Stimulation (PPOS) and GnRH antagonist. Infertile women who require Preimplantation Genetic Testing for various medical indications will be recruited and randomly assigned to one of the two treatment groups. The primary outcome measured will be the euploidy rate of the resulting blastocysts, which is crucial for successful implantation and pregnancy. The study aims to determine which protocol yields a higher rate of genetically normal embryos.
Who should consider this trial
Good fit: Ideal candidates are women under 43 years old with specific infertility issues requiring Preimplantation Genetic Testing.
Not a fit: Patients with functional ovarian cysts, those receiving oocyte donation, or with untreated hydrosalpinx or endometrial polyps may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the chances of successful pregnancies for women undergoing IVF by identifying the more effective ovarian stimulation protocol.
How similar studies have performed: Other studies have explored similar protocols in IVF, but the specific comparison of PPOS and GnRH antagonist in this context 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) \>=5 on day 2-5 of the period * PGT-A indicated for advanced maternal age (\>=38 years), recurrent miscarriage (\>=2 consecutive miscarriage) and repeated implantation failure (\>=4 embryos replaced or \>=2 blastocysts replaced without success), recurrent foetal aneuploidy Exclusion Criteria: * Presence of a functional ovarian cyst with E2\>100 pg/mL * Recipient of oocyte donation * Presence of hydrosalpinx or endometrial polyp which is not surgically treated
Where this trial is running
Shanghai, Shanghai
- Shanghai JiAi Genetics & IVF Institute — Shanghai, Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: HE LI, MD
- Email: lihe198900@163.com
- Phone: +8613817223099
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.
Conditions: Preimplantation Genetic Testing, Progestin-primed Ovarian Stimulation, Euploid Rate, GnRH Antagonist