Vitrification of Oocytes Matured by CAPA-IVM

Recruiting

• Conditions: Fertility Preservation

• Registration Number: NCT06157619
• Lead Sponsor: Centro de Fertilidad y Reproducción Asistida, Peru

Brief Summary

It has been reported that the potential of In Vitro matured oocytes might be affected by the vitrification process. In fact, the freezing and thawing procedures routinely used in IVF laboratories, have not yet been adapted to oocytes coming from early antral follicles (normally used for In Vitro Maturation).

This study aims to compare 2 existing protocols for the Vitrification of In Vitro matured oocytes.

Detailed Description

This is a single-center non-blinded observational study.

The proposed study will follow a sibling oocyte design in infertile patients. In Vitro Maturation will be performed by using the Capacitation-IVM (CAPA-IVM) methodology.

All cumulus-oocyte complexes (COC) recovered from the patient will be cultured in CAPA medium for 24 hours and then matured for 30 hours (IVM). A minimum of 10 metaphase II (MII) stage oocytes are expected from each CAPA-IVM procedure.

After CAPA-IVM culture, the mature oocytes (MII) will be randomly divided (50/50) into two groups to be subjected to the two vitrification protocols.

In a second step (next cycle), the oocytes from each group will be thawed and fertilized by Intracytoplasmic sperm injection (ICSI). The derived embryos will be cultured to the blastocyst stage (Day 5/6).

The transfer of a single embryo (the one with the best quality) will be carried out. The remaining embryos will be vitrified.

Study Timeline

• Study First Submitted: 2023-11-27
• Status Verified: 2023-12
• Study Start: 2023-12
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Study First Posted: 2023-12-06
• Last Update Posted: 2023-12-06
• Primary Completion: 2024-05
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oocyte survival rate	6 months	The survival rate will be calculated by dividing the number of oocytes that survive freezing/thawing by the number of oocytes originally frozen.; Survival rate will be evaluated per patient, per vitrification protocol.

Secondary Outcome Measures

Name	Time	Method
Fertilization rate	6 months	The fertilization rate will be calculated by dividing the number of fertilized oocytes by the number of oocytes injected by ICSI.
Rate of Good quality blastocysts	6 months	The rate of good quality blastocysts will be calculated by dividing the number of good quality blastocysts by the number of fertilized oocytes.
Rate of Blastocyst formation	6 months	The rate of blastocyst formation will be calculated by dividing the number of blastocysts by the number of fertilized oocytes.
Live birth rate	15 months	The live birth rate will be calculated by dividing the number of patients with a live birth by the number of patients that underwent embryo transfer procedures.
Oocyte maturation rate	6 months	The maturation rate will be calculated by dividing the number of oocytes that mature by the number of oocytes originally plated.
Clinical pregnancy rate	15 months	The clinical pregnancy rate will be calculated by dividing the number of patients with clinical pregnancy by the number of patients that underwent embryo transfer procedures.
Cleavage rate	6 months	The cleavage rate will be calculated by dividing the number of cleaving embryos by the number of fertilized oocytes.

Trial Locations

Locations (1)

Centro de Fertilidad y Reproducción Asistida; 🇵🇪 Lima, Peru