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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Fertiga, Belgium
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Clinical evaluation: Day 3 embryo evaluation
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Clinical evaluation: Day 3 embryo evaluation
Time Frame: Day 3 of embryo culture
Day 3 embryo morphology evaluation according to the standard of care of the ART clinic
Clinical evaluation: number of cumulus-oocyte complex
Time Frame: Day 1 of embryo culture
The number of cumulus-oocyte complex at time of pick-up
Clinical evaluation: Meiosis II oocytes
Time Frame: Day 1 of embryo culture
The number of meiosis II oocytes (nominator) divided by the total number of oocytes retrieved (denominator)
Clinical evaluation: Abnormal fertilization
Time Frame: Day 1 of embryo culture
The number of abnormal fertilized oocytes on day 1 at 17+1h post insemination, as a function of all COC's inseminated
Expression profile: blastocyst formation
Time Frame: 2.5 years after study start
The expression profiles of cumulus of oocyte leading to a blastocyst and the expression profiles of cumulus of oocyte not leading to a blastocyst has been determined using RNA-Seq.
Basic clinical donor patient and stimulation characteristics: P4
Time Frame: During ovarian stimulation (max 3 weeks)
Serum values for P4 (ng/ml)
Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose
Time Frame: During ovarian stimulation (max 3 weeks)
Gonadotropin type and dose (IU) used for stimulation
Clinical evaluation: number of Follicles
Time Frame: During ovarian stimulation (max 3 weeks)
The number of follicles at time of trigger (oocyte-pick-up day-2)
Basic clinical donor patient and stimulation characteristics: E2
Time Frame: During ovarian stimulation (max 3 weeks)
Serum values for E2 (ng/L)
Clinical evaluation: Normal Fertilization
Time Frame: Day 1 of embryo culture
The number of fertilized oocytes on day 1 (presence of 2PN and 2PB assessed at 17 + 1h post-insemination), as a function of all COC's inseminate
Clinical evaluation: Day 5/6 embryo evaluation
Time Frame: Day 6 of embryo culture
Day 5/6 embryo evaluation based on the criteria of Gardner and Schoolcraft (Gardner and Schoolcraft 1999)
Clinical evaluation: Embryo utilization
Time Frame: Day 6 of embryo culture
Defined as the number of blastocyst suitable for cryopreservation and transfer as a function of the number of normally fertilized (2PN) oocytes observed on day 1 (ESHRE Special Interest Group Alpha Scientists 2017)
Clinical evaluation: Day5/6 good quality blastocyst rate
Time Frame: Day 6 of embryo culture
Defined as the proportion of 2PN zygotes which are good-quality blastocyst on Day 5/6 (116 +-2h and 140 +-2h post-insemination) (ESHRE Special Interest Group of Embryology and Alpha Scientists in Reproductive Medicine 2017)
Secondary Outcomes
- Normalized messenger ribonucleic acid (mRNA) expression(2.5 years after study start)
- Biochemical pregnancy(Day 10 after embryo transfer)
- Expression profile: pregnancy prediction(2.5 years after study start)
- Clinical pregnancy with positive fetal heartbeat(week 5-6 after embryo transfer)