CTRI/2016/10/007367已完成3 期
A Phase III, Randomized, Open-Label, Multiple-Dose, Parallel-Group Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of Recombinant Human FSH of Cadila Healthcare Limited, India as compared to Gonal-F TM Administered Subcutaneously in Female Patients Undergoing Assisted Reproductive Technology.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
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.Females between 22-38 years of age with regular menstrual cycle of 24-35 days
- •2.Infertile female patients undergoing Controlled Ovarian Hyperstimulation
- •(COH) for Assisted Reproductive Technology (ART)
- •3.BMI between 18-30 kg/m2 inclusive
- •4.Transvaginal ultrasound documenting the presence of both ovaries without
- •abnormalities and normal uterine adnexa
- •5.Clinically acceptable ranges of Basal Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2) at the time of enrollment
- •6.Antral follicle count (AFC) >= 8 to <= 25 follicles (sum of both ovaries)
- •7.Willing to comply with all the study requirements and procedures
- •8.Normal or clinically insignificant haematology, serum chemistry and urinalysis
- •parameters during screening
- •9.Willing to provide written informed consent
排除标准
- •1.History of allergy or hypersensitivity reactions to FSH or any other ingredients of the formulation
- •2.Use of any FSH preparation or clomiphene citrate within 60 days of randomization
- •3.History of >= 2 succeeding ART retrieval cycles (which includes fresh and frozen embryo transfers before the study cycle without clinical pregnancy
- •4. Presence of polycystic ovaries (PCO)
- •5. Previous history of severe ovarian hyperstimulation syndrome
- •6. Presence of severe endometriosis (ASRM stage 3 or stage 4) and hydrosalpinx
- •7. Presence or history of thrombophlebitis or thromboembolic disorders
- •8.History of extrauterine pregnancy in the previous 3 months
- •9.History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt)
- •10.Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
- •11.Positive Pap Smear at screening
- •12.combination or hormonal implants <= 6 months prior to screening
- •13.Positive Pregnancy test at screening
研究者
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