No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 35
Sex
Female
Study type
Observational
Participants needed
160 (estimated)
Sponsor
Fertiga, Belgium · Industry
Who this trial is looking for
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This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist \& hr-FSH with GnRH Agonist trigger, 2) Progesterone \& hr-FSH with GnRH Agonist trigger.
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Eligibility 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' s…
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)
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