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

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA (Other)

Overall Status

Recruiting

CT.gov ID

NCT06103383

Collaborator

(none)

Enrollment

Location

Arm

22.1

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female Oocyte Maturation	Drug: Controlled ovarian stimuation Procedure: Oocyte pick up Procedure: Oocyte in vitro maturation Procedure: Oocyte in vitro activation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, observational, single-center, prospective cohort pilot studyProspective, observational, single-center, prospective cohort pilot study

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 28, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Controlled ovarian stimuation 3 days stimullation protocol using hMG-HP Procedure: Oocyte pick up Surgical oocyte pick up without triggering Procedure: Oocyte in vitro maturation In vitro maturation procedure Procedure: Oocyte in vitro activation In vitro oocyte activation procedure

Arm

Intervention/Treatment

Experimental: 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.

Drug: Controlled ovarian stimuation

3 days stimullation protocol using hMG-HP

Procedure: Oocyte pick up

Surgical oocyte pick up without triggering

Procedure: Oocyte in vitro maturation

In vitro maturation procedure

Procedure: Oocyte in vitro activation

In vitro oocyte activation procedure

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

-Inclusion criteria:

Women between 18-35 years old who have belonged to the egg donation program. Donors who agree to participate in the study after informing and signing the Informed Consent.

Documented previous good response to ovarian stimulation (at least 10 total oocytes and/or 8 MII).

Donors with at least one previous donation cycle, in which all oocytes obtained were freshly fertilized.

Donors who have already done all their donation cycles allowed by law. No personal or family history of interest.

From the medical point of view:

Body mass index between 18-25 kg/m2. Normal uterus and ovaries, without organic pathology. No polycystic ovaries Antral follicle count (AFC) >12 in the sum of the two ovaries on day 2-3 of the menstrual cycle. Normal karyotype Negative screening for infectious diseases (Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency Virus and Syphilis). General analysis with hemogram, hemostasis and biochemistry with parameters within normality.

-Exclusion criteria:

Any systemic or metabolic disorder that contraindicates the use of gonadotropins.

Any medical condition that implies non-inclusion in the oocyte donation program.

Taking hormonal contraceptives within the last 3 months.