Vitrification of Oocytes Matured by CAPA-IVM

December 4, 2023 updated by: Sergio Romero, Centro de Fertilidad y Reproducción Asistida, Peru

Vitrification of In Vitro Matured Oocytes Following the CAPA-IVM Methodology

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Peru
      • Lima, Peru, 15036
        • Recruiting
        • Centro de Fertilidad y Reproducción Asistida
        • Contact:
          • Ygor Pérez, M.D. MSc
        • Principal Investigator:
          • Francisco Escudero, M.D., MSc
        • Principal Investigator:
          • María Alejandra Pérez
        • Sub-Investigator:
          • Patricia Orihuela, M.D., MSc
        • Sub-Investigator:
          • Ygor Pérez, M.D., MSc
        • Sub-Investigator:
          • Mario García, M.D.
        • Sub-Investigator:
          • Ingrid Zorrilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Infertile patients that are subjected to In Vitro maturation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Formulation of Vitrification medium #1
Hydroxypropyl cellulose (HPC), Ethylene glycol, Dimethyl sulfoxide (DMSO) y trehalose
Procedure: Oocyte Vitrification /Warming
In Vitro matured oocytes will be randomly assigned to any of the two Vitrification protocols
Formulation of Vitrification medium #2
Human serum albumin (HSA), Ethylene glycol, Dimethyl sulfoxide (DMSO) & sucrose
Procedure: Oocyte Vitrification /Warming
In Vitro matured oocytes will be randomly assigned to any of the two Vitrification protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte survival rate
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte maturation rate
Time Frame: 6 months
The maturation rate will be calculated by dividing the number of oocytes that mature by the number of oocytes originally plated.
6 months
Fertilization rate
Time Frame: 6 months
The fertilization rate will be calculated by dividing the number of fertilized oocytes by the number of oocytes injected by ICSI.
6 months
Cleavage rate
Time Frame: 6 months
The cleavage rate will be calculated by dividing the number of cleaving embryos by the number of fertilized oocytes.
6 months
Rate of Blastocyst formation
Time Frame: 6 months
The rate of blastocyst formation will be calculated by dividing the number of blastocysts by the number of fertilized oocytes.
6 months
Rate of Good quality blastocysts
Time Frame: 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.
6 months
Clinical pregnancy rate
Time Frame: 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.
15 months
Live birth rate
Time Frame: 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.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Fertilidad y Reproducción Asistida, Peru

Collaborators

Centro de Estudios e Investigaciones en Biología y Medicina Reproductiva

Investigators

  • Principal Investigator: Sergio Romero, PhD, Research Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Estimated)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SIDISI 23001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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