CTRI/2014/09/005010已完成3 期
A Prospective, Multicenter, Randomized, Open, Clinical Trial to Compare Clinical Equivalence Of Two Brands of Recombinant Human Chorionic Gonadotropin For Inducing Final Follicular Maturation in Intrauterine Insemination Cycles
Bharat Serums and Vaccines Ltd0 个研究点目标入组 217 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 217
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.Female subjects aged 20 to 37 years (both inclusive)
- •2.BMI between 18 and 30 kg/m2
- •3.Less than 3 previous completed cycles
- •4.Anovulatory infertility, grade I or II endometriosis , PCOS or unexplained factor
- •5.Normogonadotropic subjects with normal Day 2 hormonal profile ( FSH (2.5 to 10.2 mIU/ml), LH (1.9 to 12.5mIU/ml), E2 (18.9 to 246.7pg/ml) TSH (0.35 to 5.5µIU/ml) and Prolactin (2.8 to 29.2ng/ml)
- •6.Criteria for hCG administration fulfilled (at least 1 follicle and not more than 5 follicles with diameter of > 18mm with acceptable serum E2 concentration not more than 1800 pg/ml)
- •7.Hysterosalpingography or laparoscopy, within 3 years before randomization, documenting a uterus consistent with expected normal function (e.g. no clinically interfering uterine fibroids) and at least one patent tube.
- •8.Semen parameters compatible with IUI using husband/donor sperm and semen analysis documenting >10 million/ml sperm count.
排除标准
- •1.Female subjects aged less than 20 yrs and more than 37 years
- •2.Premature ovarian failure
- •3.Subjects requiring more than 300 IU of HMG/FSH as starting dose in previous treatment cycles or a known poor responder
- •4.Subjects with hypogondatropic hypogonadism
- •5.Uncontrolled thyroid or adrenal dysfunction
- •6.Previous history of severe Ovarian Hyper Stimulation Syndrome (OHSS)
- •7.Ovarian cysts > 10 mm or enlargement not due to polycystic ovary syndrome
- •8.Bilateral tubal block
- •9.Abnormal gynaecological bleeding of unknown origin
- •10.More than 3 previous failed IUIs
- •11.Subjects affected by pathologies associated with any contraindication of being pregnant
- •12.Neoplasias
- •13.Use of concomitant medication that might interfere with study evaluations
- •14. Hypersensitivity to any trial product
研究者
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