Optimizing in vitro maturation of oocytes from egg donors
Second Phase of the Pilot Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women
This study is testing a new way to help egg donor women produce mature eggs in the lab to improve the success of fertility treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Instituto Valenciano de Infertilidad, IVI VALENCIA Academic / other |
| Locations | 1 site (Valencia) |
| Trial ID | NCT06103383 on ClinicalTrials.gov |
What this trial studies
This study focuses on improving the in vitro maturation (IVM) technique to obtain mature oocytes from immature ones in egg donor women. It aims to achieve nuclear maturation of oocytes to the metaphase II stage while also assessing cytoplasmic maturation through artificial oocyte activation. The study involves controlled ovarian stimulation, oocyte pick-up, and subsequent maturation and activation processes. This is the second phase of a pilot study aimed at refining these techniques within an IVF laboratory setting.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-35 who have previously participated in an egg donation program and have shown a good response to ovarian stimulation.
Not a fit: Patients who do not meet the eligibility criteria, such as those with a body mass index outside the specified range or with a history of polycystic ovaries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the efficiency of oocyte maturation, potentially improving outcomes for infertility treatments.
How similar studies have performed: Other studies have shown promise in optimizing in vitro maturation techniques, but this specific approach is still being developed.
Eligibility criteria
Show full inclusion / exclusion criteria
-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.
Where this trial is running
Valencia
- Ivi Valencia — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Ernesto Bosch, PhD — IVIRMA Valencia
- Study coordinator: LAURA CARACENA, Msr
- Email: laura.caracena@ivirma.com
- Phone: 034 963050900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.