Evaluating oocyte competence in egg donors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fertilab
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Tom Adriaenssens, PhD
• Email: tom.adriaenssens@fertiga.com
• Phone: 024774645

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.