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Vitrification of Oocytes Matured by CAPA-IVM

C

Centro de Fertilidad y Reproducción Asistida, Peru

Status

Enrolling

Conditions

Fertility Preservation

Treatments

Procedure: Oocyte Vitrification /Warming

Study type

Observational

Funder types

Other

Identifiers

NCT06157619
SIDISI 23001

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

20 to 37 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Formulation of Vitrification medium #1
Description:
Hydroxypropyl cellulose (HPC), Ethylene glycol, Dimethyl sulfoxide (DMSO) y trehalose
Treatment:
Procedure: Oocyte Vitrification /Warming
Formulation of Vitrification medium #2
Description:
Human serum albumin (HSA), Ethylene glycol, Dimethyl sulfoxide (DMSO) \& sucrose
Treatment:
Procedure: Oocyte Vitrification /Warming

Trial contacts and locations

1

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Central trial contact

Sergio Romero, PhD

Data sourced from clinicaltrials.gov

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