Vitrification of Oocytes Matured by CAPA-IVM

Last updated: December 4, 2023
Sponsor: Centro de Fertilidad y Reproducción Asistida, Peru
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Oocyte Vitrification /Warming

Clinical Study ID

NCT06157619
SIDISI 23001
  • Ages 20-37
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Either

  • Patients with Polycystic ovary morphology: At least 25 follicles (2-9 mm) throughoutthe ovary and/or increased ovarian volume (>10ml) (it is enough for 1 ovary to meetthese criteria)
  • Patients with good ovarian reserve: High antral follicle count (AFC): ≥ 20 antralfollicles in both ovaries or Anti-müllerian hormone (AMH) value ≥3.5 ng/ml In both cases, without significant uterine or ovarian anomalies

Exclusion

Exclusion Criteria:

  • There are contraindications for the administration of gonadotropins, oralcontraceptives 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

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Oocyte Vitrification /Warming
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • Centro de Fertilidad y Reproducción Asistida

    Lima, 15036
    Peru

    Active - Recruiting

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