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

Not Applicable

Recruiting

• Conditions: Infertility, Female; Oocyte Maturation
• Interventions: Drug: Controlled ovarian stimuation; Procedure: Oocyte pick up; Procedure: Oocyte in vitro maturation; Procedure: Oocyte in vitro activation

• Registration Number: NCT06103383
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-28
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Donors with history of optimal ovarian response	Controlled ovarian stimuation	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.
Donors with history of optimal ovarian response	Oocyte pick up	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.
Donors with history of optimal ovarian response	Oocyte in vitro maturation	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.
Donors with history of optimal ovarian response	Oocyte in vitro activation	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.

Primary Outcome Measures

Name	Time	Method
Oocyte in-vitro maturation	1 YEAR	To evaluate the rate of potentially competent oocytes (after the in vitro maturation).
Oocyte activation	1 YEAR	To evaluate the rate of potentially competent oocytes after oocyte activation process.

Secondary Outcome Measures

Name	Time	Method
Oocyte recovery rate	1 year	To evaluate Oocyte recovery rate per punctured follicle
In vitro nuclear maturation rate	1 year	To evaluate In vitro nuclear maturation rate per punctured follicle
Artificial oocyte activation rate.	1 year	To evaluateArtificial oocyte activation rate. per punctured follicle

Trial Locations

Locations (1)

Ivi Valencia; 🇪🇸 Valencia, Spain