A clinical study to evaluate the efficacy and safety of Fertilix Ova as an Add on therapy to Letrozole in Ovarian reserve and Ovulation induction.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 3. Changes from base line to 12 weeks in Quality of life- Questionnaires (Short Form Health-12 ). [pre and post study]
研究概览
简要总结
Fifty participants with Infertility/ decreased ovarian reserve & ovulation failure will be selected in two arms of 25 in each.
Arm 1: Fertilix Ova (Taken once daily orally) + Letrozole (Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5-7.5 mg mg in the next cycle if there is no response to 2.5 mg)- 12 weeks/ 3 cycles
Arm 2: Letrozole alone- 12 weeks/ 3 cycles (Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5-7.5 mg in the next cycle if there is no response to 2.5 mg)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female subjects with age 21 – 45 years
- •BMI less than 35
- •Infertility due to anovulation.
- •No recent (within 6 months) treatment for induction of ovulation
- •Patient should have not participated in any other clinical trial during the past 3 months.
- •Participants, who are willing to give written, signed and dated informed consent to participate in the study.
排除标准
- •Uncontrolled Diabetes (HbA1c greater than 10)
- •Moderate to severe renal or hepatic impairment
- •Received any other investigational medicine within 7 days prior to screening which can interfere with investigational product activity
- •Suffering from any illness which will interfere with present study as decided by clinical investigator
- •History of hypersensitivity to any of the test products.
- •Participants who are pregnant.
- •Any other condition decided as unfit for study by Clinical investigator.
结局指标
主要结局
3. Changes from base line to 12 weeks in Quality of life- Questionnaires (Short Form Health-12 ). [pre and post study]
时间窗: Day 0, Week 4, Week 8 and Week 12
The primary outcome measures to study the efficacy are as follows:
时间窗: Day 0, Week 4, Week 8 and Week 12
1. Ovulation rate – monitored by USG abdomen.
时间窗: Day 0, Week 4, Week 8 and Week 12
2. Ovarian reserve by monitoring Estrogen and AMH. [ time frame over 12 weeks/ 3 cycles- at baseline and post study]
时间窗: Day 0, Week 4, Week 8 and Week 12
次要结局
- 1. Pregnancy rate(2. To demonstrate safety and tolerability of study product by Clinical AEs (If any))
研究者
Dr Anuradha MBBS MD
SRM Medical College Hospital and Research Centre