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

NCT06103383 | Recruiting

• 1 other identifier: 2109-VLC-083-EB
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female; Oocyte Maturation

Keywords

IN VITRO MATURATION; OOCYTE ACTIVATION; FOLLICULAR PUNCTURE; hMG-HP; OOCYTE DONNORS

Outcome Measures

Primary Outcomes (2)

• Oocyte in-vitro maturation

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

  1 YEAR

• Oocyte activation

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

  1 YEAR

Secondary Outcomes (3)

• Oocyte recovery rate

  1 year

• In vitro nuclear maturation rate

  1 year

• Artificial oocyte activation rate.

  1 year

Study Arms (1)

Donors with history of optimal ovarian response

EXPERIMENTAL

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; Procedure: Oocyte pick up; Procedure: Oocyte in vitro maturation; Procedure: Oocyte in vitro activation

Interventions

Controlled ovarian stimuation DRUG

3 days stimullation protocol using hMG-HP

Donors with history of optimal ovarian response

Oocyte pick up PROCEDURE

Surgical oocyte pick up without triggering

Donors with history of optimal ovarian response

Oocyte in vitro maturation PROCEDURE

In vitro maturation procedure

Donors with history of optimal ovarian response

Oocyte in vitro activation PROCEDURE

In vitro oocyte activation procedure

Donors with history of optimal ovarian response

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Any systemic or metabolic disorder that contraindicates the use of gonadotropins.
• Taking hormonal contraceptives within the last 3 months.

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead

Study Sites (1)

Ivi Valencia

Valencia, 46015, Spain

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

In Vitro Oocyte Maturation Techniques

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Ernesto Bosch, PhD

  IVIRMA Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LAURA CARACENA, Msr

CONTACT

034 963050900; laura.caracena@ivirma.com

CRISTINA RODRIGUEZ, Mss

CONTACT

034 963050900; cristina.rodriguez@ivirma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, observational, single-center, prospective cohort pilot study

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 26, 2023
• Study Start: February 28, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)