Health Condition 1: N979- Female infertility, unspecified
Conditions
Interventions
Intervention1: Elagolix: 150 mg twice daily (BID) at 12-hour intervals
Control Intervention1: Elagolix: 150 mg twice daily (BID) at 12-hour intervals
Control Intervention2: Cetrorelix 0.25 mg OR Ganir
Sponsors
Dr Kundan V Ingale
Eligibility
Inclusion criteria
Inclusion criteria: Women aged 21 to 38 years undergoing their first IVF cycle Normal ovarian reserve AMH more than equal to 1 ng per mL and AFC more than equal to 8 BMI 18 to 30 kg per m No previous ovarian surgery Signed written informed consent prior to any study specific procedure
Exclusion criteria
Exclusion criteria: History of poor ovarian response less than equal to 3 oocytes retrieved in any prior stimulation Known contraindications to GnRH antagonists Known hypersensitivity to Elagolix or any of its excipients Significant hepatic or renal impairment defined as alanine aminotransferase or aspartate aminotransferase more than two times the upper limit of normal, or estimated glomerular filtration rate less than sixty milliliters per minute per one point seven three square meters Concurrent use of medications known to affect bone metabolism example bisphosphonates corticosteroids denosumab Donor oocyte recipients excluded to maintain homogeneity of study population Participation in another clinical trial within 30 days prior to enrollment Positive infectious disease screening HBsAg Anti HCV HIV 1 and 2 VDRL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of premature LH surge or progesterone rise on trigger day defined as LH more than 10 IU per L on trigger day OR Progesterone more than 1.5 ng per mL on trigger dayTimepoint: 8-14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Total number of oocytes retrievedTimepoint: At oocyte retrieval approximately 34 to 36 hours after trigger administration;Mature oocyte rate MII oocytes divided by total oocytes retrievedTimepoint: Assessed at oocyte retrieval approximately 34 to 36 hours after trigger;Fertilization rate 2PN divided by inseminated oocytesTimepoint: Assessed on Day 1 after oocyte retrieval during fertilization assessment;Blastocyst formation rate total blastocysts divided by fertilized oocytesTimepoint: Assessed on Day 5 to Day 6 after oocyte retrieval during embryo culture;High quality blastocyst rate blastocysts graded greater than or equal to 3BB according to Gardner classification divided by total oocytes retrievedTimepoint: Assessed on Day 5 to Day 6 after oocyte retrieval;Clinical pregnancy rate defined as intrauterine gestational sac with cardiac activityTimepoint: Assessed at 6 to 7 weeks of gestation following embryo transfer;Ongoing pregnancy rateTimepoint: Assessed at 12 weeks gestation following embryo transfer | — |
Countries
India
Contacts
Public ContactDr Kundan V Ingale
Nirmiti Clinic
Outcome results
None listed