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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Ivi Valencia
RECRUITING
Valencia
Contact Information
Primary
LAURA CARACENA, Msr
laura.caracena@ivirma.com
034 963050900
Backup
CRISTINA RODRIGUEZ, Mss
cristina.rodriguez@ivirma.com
034 963050900
Time Frame
Start Date: 2023-02-28
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 10
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Instituto Valenciano de Infertilidad, IVI VALENCIA

This content was sourced from clinicaltrials.gov

Similar Clinical Trials