Comparing two methods for freezing matured oocytes
Vitrification of In Vitro Matured Oocytes Following the CAPA-IVM Methodology
This study is testing two different ways to freeze matured eggs to see which method works better for people struggling with infertility.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 37 Years |
| Sex | Female |
| Sponsor | Centro de Fertilidad y Reproducción Asistida, Peru Academic / other |
| Locations | 1 site (Lima) |
| Trial ID | NCT06157619 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of two different vitrification protocols for oocytes that have been matured using the Capacitation-IVM (CAPA-IVM) technique. The study will involve infertile patients, where all cumulus-oocyte complexes will be cultured in CAPA medium before being matured and then randomly divided into two groups for vitrification. Following the vitrification process, the oocytes will be thawed and fertilized using Intracytoplasmic sperm injection (ICSI), with the best quality embryo being selected for transfer. The study is designed to enhance the understanding of how vitrification affects the potential of in vitro matured oocytes.
Who should consider this trial
Good fit: Ideal candidates include infertile patients with either polycystic ovary morphology or good ovarian reserve as indicated by high antral follicle count or elevated AMH levels.
Not a fit: Patients with significant uterine or ovarian anomalies, high-grade endometriosis, or those undergoing oocyte donation cycles may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the success rates of fertility preservation techniques for patients undergoing in vitro maturation.
How similar studies have performed: While there have been studies on oocyte vitrification, this specific approach using CAPA-IVM is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Either * Patients with Polycystic ovary morphology: At least 25 follicles (2-9 mm) throughout the ovary and/or increased ovarian volume (\>10ml) (it is enough for 1 ovary to meet these criteria) * Patients with good ovarian reserve: High antral follicle count (AFC): ≥ 20 antral follicles in both ovaries or Anti-müllerian hormone (AMH) value ≥3.5 ng/ml In both cases, without significant uterine or ovarian anomalies Exclusion Criteria: * There are contraindications for the administration of gonadotropins, oral contraceptives and/or other drugs used in the framework of the present study. * Preimplantation Genetic Testing (PGT) Cycles * Oocyte donation cycles * Medical contraindication for pregnancy. * High grade endometriosis (\> grade 2) * Cases with extremely poor sperm
Where this trial is running
Lima
- Centro de Fertilidad y Reproducción Asistida — Lima, Peru (Recruiting)
Study contacts
- Principal investigator: Sergio Romero, PhD — Research Director
- Study coordinator: Sergio Romero, PhD
- Email: sergioromero@cefra.com.pe
- Phone: +51-1-2230363
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.