CTRI/2022/03/040842已完成3 期
A Randomized, Parallel-group, Multi-Center, Assessor-blind Phase 3 Study to Compare the Efficacy, Safety and Ease of Use of Two Follicle Stimulating Hormone -Human Recombinant (r-hFSH) 900 IU (66.0 µg) / 1.5mL Solution for Injection in Prefilled Pen (Foligraf®- Manufactured by BSV and Gonal-f® Manufactured by Merck Serono) in Subjects Undergoing Controlled Ovarian Stimulation for Assisted Reproductive Technology - REFRESH
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
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
- •Subject has indication ART using COS.
- •-Subject has regular menstrual cycle of 21-35 days.
- •-Subject has one of the following:
- •a. FSH level <10 IU/L and Estradiol levl <80 pg/mL at day 2 or 3
- •b. AMH level between 1 to 3.5 ng/mL during the menstrual cycle
- •-Subject has an AFC of 10- 25, follicle =10 mm in diameter before ovarian stimulation
- •- Subject has a BMI =18 and <30 kg/m2
- •- Subject has results of clinical laboratory tests within normal reference range
- •- Subject and her partner are willing to provide written informed consent and comply
排除标准
- •-Subject has history of >2 failed ART cycles
- •-Subject with history of any endocrine abnormality, with documented hormone levels outside the reference range, which are clinically relevant, at screening
- •-Subject with a history of ovarian hyper-response (i.e., previous COS cycle with >25 follicles of =11 mm in diameter on USG) or OHSS
- •- Subject with documented polycystic ovarian syndrome (PCOS) at the time of screening
- •- Subject with only one ovary or ovarian abnormality (including endometrioma >10 mm; visible on USG), at screening
- •- Subject with documented severe endometriosis (American Society of Reproductive Medicine stage 3 or stage 4) or hydrosalpinx, at screening
- •-Subject with submucosal fibroids =5 cm or any other clinically relevant pathology, which could impair embryo implantation or pregnancy continuation, at screening
- •- Subject with a history of extrauterine pregnancy within 3 months of screening
- •- Subject with history of poor response to gonadotropin treatment (retrieval of <4 oocytes) in the previous ART cycle
- •- Subject with history of =3 miscarriages, at any time prior to screening
- •- Subject who has tested positive for Human Immunodeficiency Virus, Hepatitis B or Hepatitis C at screening
- •- Subject known to be allergic, hypersensitive, or intolerant to any of the preparations of r hFSH or its excipients, that will be used in the study
- •-Subject with contraindications to the use of gonadotropins (e.g., tumours, undiagnosed vaginal bleeding, or ovarian cysts) or GnRH antagonists
- •- 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 investigator’s discretion might interfere with the study
- •- Subject with history of malignancy
- •- Subject who smokes or has stopped smoking within the last 3 months prior to screening
- •-Subject with history of alcohol or drug abuse within 12 months prior to screening
- •- Subject who has received any treatment listed below within 5 half-lives prior to screening:
- •a.Any agent(s) known to affect ovulation (e.g., neuroleptics);
- •b.Drugs known or suspected to be teratogenic in nature.
- •- 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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