Evaluating oocyte competence in egg donors
An Observational Study to Evaluate the Expression Profiles of Oocyte-potency-related Genes in Cumulus Cells of Women Treated With Human Recombinant FSH (Hr-FSH)and Triggered With GnRH Agonist in an Oocyte Donation Program
This study is testing how certain cell signals in egg donors can help predict which eggs are most likely to be successful for fertility treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Fertiga, Belgium Industry-sponsored |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06280677 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the predictive mRNA expression profiles in cumulus cells from individual oocytes in two patient cohorts undergoing different stimulation protocols. The cohorts include patients receiving GnRH Antagonist and hr-FSH with a GnRH Agonist trigger, and those on Progesterone and hr-FSH with a GnRH Agonist trigger. By analyzing these profiles, the study seeks to determine the potential competence of oocytes for fertility treatments. Participants will be egg donors aged 18 to 35 who meet specific health criteria and provide informed consent for the study.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy female egg donors aged 18 to 35 with a BMI between 17 and 30 and regular menstrual cycles.
Not a fit: Patients with a BMI outside the specified range, irregular menstrual cycles, or a history of poor oocyte maturation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the selection process for oocytes in fertility treatments, potentially improving outcomes for patients facing infertility.
How similar studies have performed: While similar studies have explored oocyte competence, this specific approach using mRNA expression profiles in cumulus cells is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Donor: * Patients are 18 to 35 years old * BMI between 17-30 * Regular menstrual cycles * AFC \> 8 * Patient profile in compliance with SEF (Sociedad Española de Fertilidad) directives for egg donation (medical, psychological and genetic screening, informed consent) * Patients' stimulation: GnRH Antagonist \& hr-FSH with GnRH Agonist trigger or Progesterone \& hr-FSH with GnRH Agonist trigger * Patients agree that the oocytes will be denuded for cumulus testing and provide written informed consent for participation to the study Exclusion Criteria Donor: * BMI \< 17 or \> 30 * Extreme irregular menstrual cycles (\<20 days or \>40 days) * AFC \< 8 * \<8 MII on previous egg retrieval * Women with history of poor oocyte maturation or known maturation defect or unexplained failure in previous treatments * Patients that fail to comply with SEF (Sociedad Española de Fertilidad) directives for egg donation (medical, psychological and genetic screening, informed consent) Inclusion Criteria Recipient: * Patients applying for ART egg donation with fresh/frozen sperm from the partner or frozen donor sperm. With eSB-FET in modified natural cycle or an HRT cycle. * Patients are from 18 to 50 years old. * Patients will be treated by ICSI (intracytoplasmic sperm injection) and eSB-FET (elective Single Blastocyst Frozen Embryo Transfer) * Recipient patients agree that the donors' oocytes will be denuded for cumulus testing and provide written informed consent for participation to the study Exclusion Criteria for oocyte Recipients * Patient included in any other prospective study. * BMI \< 17 or \> 35 * Severe uterine factor: Multiple myomectomy, multiple fibroids, major uterine malformation (unicorn, septum), Asherman Sd, severe adenomyosis * Repeated Implantation Failure or Repeated Pregnancy Loss after euploid Single Blastocyst Transfer * Severe male factor: Abnormal Caryotype or FISH, severe OAT / Cripto-Azoospermia, DNA Fragmentation \>50% after medical treatment * TESE / TESA (testicular sperm extraction/aspiration)
Where this trial is running
Barcelona
- Fertilab — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Tom Adriaenssens, PhD
- Email: tom.adriaenssens@fertiga.com
- Phone: 024774645
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.