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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

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

• 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

• 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

Locations
Other Locations
Spain
Fertilab
RECRUITING
Barcelona
Contact Information
Primary
Tom Adriaenssens, PhD
tom.adriaenssens@fertiga.com
024774645
Time Frame
Start Date: 2024-02-16
Estimated Completion Date: 2026-09
Participants
Target number of participants: 160
Treatments
GnRH Antagonist & hr-FSH
Patients stimulated with GnRH Antagonist \& hr-FSH with GnRH Agonist trigger
Progesterone & hr-FSH
Patients stimulated with Progesterone \& hr-FSH with GnRH Agonist trigger
Related Therapeutic Areas
Sponsors
Collaborators: Ferring Pharmaceuticals, Fertilab
Leads: Fertiga, Belgium

This content was sourced from clinicaltrials.gov

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