CTRI/2016/06/006993进行中（未招募）3 期
A randomized, multicentre, parallel-group, assessor-blind Phase III study to compare the efficacy and safety of Foligraf� and Gonal-F® 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
- 进行中（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.Woman, between 20 and 39 years of age ;
- •2.Subject has an indication for ART using COS;
- •3.Subject has a regular menstrual cycle of 21-35 days (both inclusive);
- •4.Subject has normal FSH level
- •5.Subject has normal estradiol levels
- •6.Subject has good AFC
- •7.Subject has a normal body mass index
- •8.Subject has results of clinical laboratory tests (haematology, blood chemistry, and urinalysis) within normal reference range, or outside the reference range
- •9.Subject and her partner are willing to provide written informed consent and comply with the study procedures.
排除标准
- •1. Subject has history of successive ART cycles
- •2. Subject with history of any endocrine abnormality
- •3. Subject with a history of ovarian hyperresponse
- •4. Subject with documented polycystic ovarian syndrome
- •5. Subject with only one ovary or ovarian abnormality
- •6. Subject with documented severe endometriosis
- •7. Subject with submucosal fibroids or any other clinically relevant pathology, which could impair embryo implantation or pregnancy continuation
- •8. Subject with a history of extrauterine pregnancy
- •9. Subject with history of poor response to gonadotropin treatment in the previous ART cycle;
- •10. Subject with history of miscarriages
- •11. Subject who have tested positive for HIV, Hepatitis B or Hepatitis C at screening;
- •12. Subject known to be allergic, hypersensitive, or intolerant to any of the preparations of r hFSH
- •13. Subject with contraindications to the use of gonadotropins
- •14. Subject with a history of epilepsy, thrombophilia, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, auto-immune disease or any active infection, requiring treatment which at the investigatorâ??s discretion might interfere with the study;
- •15. Subject with history of malignancy;
- •16. Subject who smokes or has stopped smoking within the last 3 months prior to screening;
- •17. Subject with a history of alcohol or drug abuse
- •18. Subject who has received any treatment that can have teratogenic effect or affect ovulation
- •19. Subject who has received an investigational product or has used an invasive investigational medical device within 30 days before the planned first dose of the study drug; or is currently enrolled in an investigational study.
研究者
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