An Observational Cohort Study to Evaluate the Expression Profiles of Oocyte-potency-related Genes in Ovarian Cumulus Cells From Patients Treated by Intracytoplasmic Sperm Injection (ICSI) That Are Treated With Recombinant Gonadotropins

Fertiga, Belgium1 site in 1 country137 target enrollmentFebruary 15, 2021

ConditionsInfertility

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infertility
Sponsor: Fertiga, Belgium
Enrollment: 137
Locations: 1
Primary Endpoint: Normalized messenger ribonucleic acid (mRNA) expression
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an observational study. The main aim is to determine the expression of potential biomarker genes in the cumulus cells isolated from individual oocytes in two patient cohorts: recombinant human Follicle Stimulating Hormone(hFSH) and recombinant hFSH:human Luteinizing Hormone(r-hLH) ratio 2:1. Algorithms from gene combinations will be identified that predict embryo quality and pregnancy outcomes.

Registry

clinicaltrials.gov

Start Date

February 15, 2021

End Date

September 1, 2025

Last Updated

7 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Fertiga, Belgium

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients are between 22-38 years old
•BMI between 17-33
•provide written informed consent
•Patients undergoing a first or second ICSI treatment cycle.
•Patients will be treated by ICSI (intracytoplasmic sperm injection)
•Patients agree that the oocytes will be denuded for cumulus testing and agree to the single blastocyst transfer.
•Patients must be predicted good ovarian responders (AMH 1-4,7 ng/ml) with 7-18 follicles of minimum 10-11 mm on trigger day (oocyte retrieval minus 2 days (OR -2)) by ultrasound following ovarian stimulation with r-hFSH or r-hFSH with r-hLH in a Gonadotropin-releasing hormone (GnRH) antagonist protocol (starting dose recombinant Follicle Stimulating Hormone (rFSH) between 150-225 IU)
•HCG trigger after stimulation (r-hCG)

Exclusion Criteria

•Women with less than 7 or more than 18 follicles at Day -2 or -3 measured by ultrasound
•Women with history of poor oocyte maturation or known maturation defect
•Irregular menstrual cycle (\< 24 or \> 35 days)
•BMI \< 17 or \> 33
•Smoking \> 10 cigarettes per day.
•Known low ovarian response based on Bologna criteria
•Combined use of urinary and recombinant gonadotropins in the current cycle
•Patients with severe endometriosis ≥ III (AFS classification)
•Polycystic ovary syndrome (PCOS), defined by revised criteria American Society for Reproductive Medicine (ASRM) European Society of Human Reproduction and Embryology (ESHRE) 2018
•Patient included in any other study

Outcomes

Primary Outcomes

Normalized messenger ribonucleic acid (mRNA) expression

Time Frame: 3 years after study start

Normalized mRNA levels of biomarker genes that are assessed in cumulus cells by reverse transcription quantitative Polymerase Chain Reaction (RT-qPCR) for each oocyte.