Health Condition 1: N979- Female infertility, unspecified
Conditions
Interventions
None listed
Sponsors
Gynoveda Femtech Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Married female participants diagnosed with primary or secondary infertility 2. Menstrual cycle- 21 to 35 days 3. History of miscarriage or habitual abortion, provided it occurred more than one year prior to enrolment 4. Acceptable ultrasound (USG) findings: Simple cysts less than 2 cm, hemorrhagic cysts less than 2 cm, follicular cysts less than 2 cm, intramural and sub serosal fibroids less than 2 cm in size. 5. Serum AMH levels between 1to 4 ng per mL with baseline ovulation may be positive or negative 6. Ability to have regular intercourse during the ovulation induction phase of the study
Exclusion criteria
Exclusion criteria: 1. Current pregnancy 2. Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids greater than 2 cm, endometriosis, cervical erosion, Ovarian cysts greater than 2 cm, (as diagnosed by USG lower abdomen and pelvis). 3. All submucosal fibroids to be excluded from the study 4. Pelvic inflammatory disease (PID), miscarriage within the last 1 year 6. History of positive for sexually transmitted infections: HIV, Hepatitis A, B, or C 7. Liver cirrhosis, chronic kidney disease, or other severe systemic illnesses 8. TORCH positive 9. All cases of hyperprolactinemia, whether controlled with medicine or not, will be excluded. 10. Known causes of infertility (e.g., tubal blockage, male factor infertility, PCOD, endometriosis, etc. 11. Current use of hormonal treatment or ovulation induction agents 12. Other known cause of infertility: endometriosis, tubal factor, uterine abnormalities 13. Uncorrected thyroid disease 14. Any systemic illness or condition affecting fertility 15. Medical conditions in which avoiding pregnancy is recommended until under improved control: poorly controlled Type 1 or Type 2 diabetes, poorly controlled hypertension. 16. Use of medications known to affect reproductive function or metabolism or that are an absolute contraindication during pregnancy within the past month. 17. Participants not willing to attempt conception during the study period 18. Use of any other investigational drug within 1 month prior to screening visit. 19. Subjects having known hypersensitivity to any ingredient of the study drug. 20. Any other condition which in the opinion of investigator would have placed the subject at risk or would have influenced the conduct of study or interpretation of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants achieving Ovulation based on follicular studyTimepoint: Screening Visit (Day up to 5 If needed), Baseline Visit (Day 0), Visit I (Day 30), Visit II (Day 60), Visit III (Day 90), Visit IV (Day 120) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of Largest Developing Follicle 2. Change in endometrial thickness 3. Number & percentage of participants who report conception 4. Change in serum AMH 5. Global assessment for overall change 6. Tolerability of study medications 7. Adverse events, clinical symptoms, signs, vitals & laboratory tests Timepoint: Screening Visit (Day up to 5 If needed), Baseline Visit (Day 0), Visit I (Day 30), Visit II (Day 60), Visit III (Day 90), Visit IV (Day 120) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed