Health Condition 1: N978- Female infertility of other origin
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Married Female patients diagnosed with primary or secondary infertility 2. Female subjects with AMH levels below 0.1 to 1 ng per ml 3. Regular menstrual cycle of 21 to 35 days 4. Subjects with normal Serum FSH level 5. Subjects with no IVF done within the last 1 year 6. Subjects willing to provide written informed consent and ready to comply with the study protocol.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum AMH levelTimepoint: Screening Visit (up to 5 days), baseline visit, Day 30, Day 60, Day 90, and Day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of conceptions confirmed (UPT) 2. Ovulation as assessed through serial follicular monitoring 3. Size of matured dominant follicle through serial follicular monitoring 4. Change in endometrial thickness. 5. Global assessment for Overall change by subject and investigator 6. Tolerability of study medications as assessed by participants and investigator 7. Safety evaluation by assessing adverse events, clinical symptoms, signs, vitals and laboratory tests Timepoint: Screening Visit (up to 5 days), baseline visit, Day 30, Day 60, Day 90, and Day 120 | — |
Countries
India
Contacts
Target Institute of Medical Education and Research Pvt. Ltd