CTRI/2019/10/021795尚未招募3 期
A randomized, assessor-blind, parallel group, multicentre Phase 3 study to compare the efficacy and safety of HP-hMG and Menopur® in subjects undergoing controlled ovarian stimulation for ART
Bharat serums and Vaccines ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subject has an indication for assisted reproductive technique
- •2. History of regular menstrual cycles
- •3. Has good ovarian reserve
- •4. Has an AFC count 10-25
- •5. Has a body mass index between 18 to 30 kg/m2
- •6. Has laboratory tests results within normal reference range
- •7. Subject and her partner are willing to provide written informed consent and comply with study procedures
排除标准
- •1. Subject has a history of >2 ART cycles
- •2. Has a history of any endocrine abnormality, with documented hormone levels outside the reference range
- •3. Has a history of ovarian hyper-response or OHSS
- •4. With documented polycystic ovarian syndrome
- •5. With only one ovary or ovarian abnormality
- •6. With documented severe endometriosis or hydrosalphinx
- •7. With submucosal fibroids
- •8. WIth a history of extra-uterine pregnancy
- •9. with a history of poor response to gonadotropin treatment in previous ART
- •10. With a history of > 3 miscarriages
- •11. Who have tested positive for HIV, Hepatitis B, or Hepatitis C
- •12. Who is allergic to preparations of HP-HMG or menopur or its excipients
- •13. with contraindication of use of gonadotropins or GnRH antagonists
- •14. With a history of epilepsy, thrombophilia, cardiovascular, gastrointestinal hepatic, renal pulmonary, auto-immune disease or any active infection
- •15. With history of malignancy
- •16. Who smokes or stopped smoking within 3 months from screening
- •17. with history of alcohol or drug abuse
- •18. who has received any treatment known to affect ovulation or known or suspected to be teratogenic
- •19. who has recieved an IP or have used invasive investivational medical devise within 30 days of enrolment in to this study.
研究者
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