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Clinical Trials/NCT06103383
NCT06103383
Recruiting
Not Applicable

Second Phase of the Pilot Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women

Instituto Valenciano de Infertilidad, IVI VALENCIA1 site in 1 country10 target enrollmentFebruary 28, 2023

Overview

Phase
Not Applicable
Intervention
Controlled ovarian stimuation
Conditions
Infertility, Female
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Enrollment
10
Locations
1
Primary Endpoint
Oocyte in-vitro maturation
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

In vitro maturation (IVM) is a technique for obtaining potentially fertilizable oocytes from immature oocytes. An oocyte must be mature both nuclearly and cytoplasmically in order to be competent in the reproductive process. Nuclear maturation involves an oocyte in metaphase II stage and is easily evaluated for its morphology. However, cytoplasmic maturation can only be evaluated by in vitro fertilization of that oocyte. A mature nuclear and cytoplasmic oocyte is the one capable of producing a viable embryo. This study aims to optimize the in vitro maturation (IVM) technique to achieve nuclear mature oocytes, i.e., to mature the oocytes up to the metaphase II stage. In addition, an artificial oocyte activation (AOA) will be carried out to check the cytoplasmic maturation of the oocytes, avoiding the generation of potentially viable embryos.

This study corresponds to a second phase of the pilot study for the development of this technique in our IVF laboratory. We will use all we have learned in the first phase, as well as the experience acquired, to advance in the optimization of this protocol.

The correct functioning of this IVM technique would mean a reduction in the costs of ovarian stimulation treatments, as lower doses and shorter stimulation times are required, which implies lower risks for women derived from the medication and less stress for them.

Registry
clinicaltrials.gov
Start Date
February 28, 2023
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Donors with history of optimal ovarian response

IVIRMA Valencia donors between the ages of 18-35 years old, with normal ovarian function, with a history of optimal ovarian response (at least 10 total oocytes and/or 8 MII) and who have already completed all their donation cycles allowed by law.

Intervention: Controlled ovarian stimuation

Donors with history of optimal ovarian response

IVIRMA Valencia donors between the ages of 18-35 years old, with normal ovarian function, with a history of optimal ovarian response (at least 10 total oocytes and/or 8 MII) and who have already completed all their donation cycles allowed by law.

Intervention: Oocyte pick up

Donors with history of optimal ovarian response

IVIRMA Valencia donors between the ages of 18-35 years old, with normal ovarian function, with a history of optimal ovarian response (at least 10 total oocytes and/or 8 MII) and who have already completed all their donation cycles allowed by law.

Intervention: Oocyte in vitro maturation

Donors with history of optimal ovarian response

IVIRMA Valencia donors between the ages of 18-35 years old, with normal ovarian function, with a history of optimal ovarian response (at least 10 total oocytes and/or 8 MII) and who have already completed all their donation cycles allowed by law.

Intervention: Oocyte in vitro activation

Outcomes

Primary Outcomes

Oocyte in-vitro maturation

Time Frame: 1 YEAR

To evaluate the rate of potentially competent oocytes (after the in vitro maturation).

Oocyte activation

Time Frame: 1 YEAR

To evaluate the rate of potentially competent oocytes after oocyte activation process.

Secondary Outcomes

  • Oocyte recovery rate(1 year)
  • In vitro nuclear maturation rate(1 year)
  • Artificial oocyte activation rate.(1 year)

Study Sites (1)

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