Health Condition 1: N979- Female infertility, unspecified
Conditions
Interventions
Intervention1: Mtorr 800 Capsules: Intended for the treatment of Female Infertility (Poor Ovarian Response).
Dosage: 1 Capsule Once a day, for 3 months.
Control Intervention1: Placebo: No effect.
D
Sponsors
Nutri Synapzz Therapeutix Private Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female between the ages of 25 and 45 (both ages inclusive), in a monogamous, heterosexual marriage, trying to conceive and having difficulty with conception. 2. Subjects with AMH Levels 3. Subjects with AFC (2mm-5mm) 4. Subjects who have not conceived after 1 year of unprotected vaginal sexual intercourse; with or without history of ART treatments. 5. Subjects with primary or secondary infertility. 6. Subjects with normal USG of pelvis with normal uterus. 7. Subjects with normal clinical breast examination.
Exclusion criteria
Exclusion criteria: 1. Subjects with pelvic pathology that compromise study objectives ,inclusive of undiagnosed vaginal bleeding. 2. Subjects who have history of insulin dependent and non-insulin dependent diabetes mellitus. 3. Subjects who are currently on or have been on follicle stimulating hormone therapy for upto 3 months prior to screening. 4. Subjects with Grade III or IV endometriosis. 5. Subjects who have history/diagnosis of cancer inclusive of subjects in remission. 6. Subjects with history of significant risk for breast cancer,endometrial cancer. 7. Subjects who have fibroadenomas in either breast and/or uterine myoma as diagnosed upto 1 year prior to screening; if not removed surgically. 8. Subjects with known history of clinically significant gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, neurological abnormalities or diseases. 9. Subjects who have undergone major surgical procedure 4 weeks prior to screening. 10. Subjects with diagnosis of HIV, HCV, HBV and other sexually transmitted diseases. 11. Subjects who are on steroids, anti-depressants, anti-psychotics. 12. Subjects who have participated in another clinical study upto 3 months prior to screening. 13. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 14. Subjects who in the opinion of the investigator are deemed unfit to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Anti Mullerian Hormone : â?¥50% increase in AMH Levels by end of study. 2. Anti Mullerian Hormone : AMH Levels of â?¥4 ng/ml by end of study. 3. Antral Follicular Count : â?¥50% increase in AFC (minimum of 2-5mm) by end of study. 4. Subject Compliance and Satisfaction: Score of â?¥20 by end of study.Timepoint: 1. Anti Mullerian Hormone :At Visit 1(Day 1), Visit 3 (Day 90). 2. Antral Follicular Count : At Visit 1 (Day 1),Visit 3 (Day 90). 3. Subject Compliance and Satisfaction:At Visit 2 (Day 45), Visit 3 (Day 90). | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti Mullerian Hormone : 25-49% increase in AMH Levels by end of study. 2. Antral Follicular Count : 25-49% increase in AFC (minimum of 2-5mm) by end of study. 3. Subject Compliance and Satisfation: Score of 15-19 by end of study. Timepoint: 1. Anti Mullerian Hormone :At Visit 1(Day 1), Visit 3 (Day 90). 2. Antral Follicular Count : At Visit 1 (Day 1),Visit 3 (Day 90). 3. Subject Compliance and Satisfaction:At Visit 2 (Day 45), Visit 3 (Day 90). | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare R & D India Private Limited
Outcome results
None listed