A Double Blinded, Prospective, Comparative, Placebo controlled, Two Arm Clinical Study to Evaluate the Efficacy and Safety of Mtorr 800 Capsules in the Treatment of Poor Ovarian Response in Adult Women to aid Conception
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- 1. Anti Mullerian Hormone : ≥50% increase in AMH Levels by end of study.
研究概览
简要总结
**Study Design:**A Double Blinded, Prospective, Comparative, PlaceboControlled, Two Arm Clinical Study.
**Study Population:**Females between the ages of 25 and 45 years (both agesinclusive) in a monogamous, heterosexual marriage, trying to conceive buthaving difficulty with conception.
**Indication:**Female Infertility (Poor Ovarian Response)
**Investigational Product Test:**Mtorr 800 Capcules
**Investigational Product Comparator:**Placebo Capsules
**Dosage:**1 OD x 3 months (1 capsule once a day, for 3 months)
**Study Duration:**3 months
**Number of Subjects:**114 subjects (so as to reach 102 evaluable subjects)
Assessments:
-
Anti Mullerian Hormone Test
-
Antral Follicular Count
-
Complete Blood Count
-
Serum Biochemistry (including LFTand RFT)
5.. Subject IP FeedbackQuestionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female between the ages of 25 and 45 (both ages inclusive), in a monogamous, heterosexual marriage, trying to conceive and having difficulty with conception.
- •Subjects with AMH Levels ≤1.5 ng/ml at the time of screening.
- •Subjects with AFC (2mm-5mm) ≤4 at the time of screening.
- •Subjects who have not conceived after 1 year of unprotected vaginal sexual intercourse; with or without history of ART treatments.
- •Subjects with primary or secondary infertility.
- •Subjects with normal USG of pelvis with normal uterus.
- •Subjects with normal clinical breast examination.
排除标准
- •Subjects with pelvic pathology that compromise study objectives ,inclusive of undiagnosed vaginal bleeding.
- •Subjects who have history of insulin dependent and non-insulin dependent diabetes mellitus.
- •Subjects who are currently on or have been on follicle stimulating hormone therapy for upto 3 months prior to screening.
- •Subjects with Grade III or IV endometriosis.
- •Subjects who have history/diagnosis of cancer inclusive of subjects in remission.
- •Subjects with history of significant risk for breast cancer,endometrial cancer.
- •Subjects who have fibroadenomas in either breast and/or uterine myoma as diagnosed upto 1 year prior to screening; if not removed surgically.
- •Subjects with known history of clinically significant gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, neurological abnormalities or diseases.
- •Subjects with diagnosis of HIV, HCV, HBV and other sexually transmitted diseases.
- •Subjects who are on steroids, anti-depressants, anti-psychotics.
- •Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •Subjects who in the opinion of the investigator are deemed unfit to participate in the study.
结局指标
主要结局
1. Anti Mullerian Hormone : ≥50% increase in AMH Levels by end of study.
时间窗: 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).
2. Anti Mullerian Hormone : AMH Levels of ≥4 ng/ml by end of study.
时间窗: 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).
3. Antral Follicular Count : ≥50% increase in AFC (minimum of 2-5mm) by end of study.
时间窗: 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).
4. Subject Compliance and Satisfaction: Score of ≥20 by end of study.
时间窗: 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).
次要结局
- 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.)