A prospective, multicenter, randomized, open, comparative clinical trial to test efficacy and safety of 2 brands of highly purified follicle-stimulating hormone in subjects undergoing their first cycle of invitro fertilization with intracytoplasmic sperm injection (ICSI).

Bharat Serums and Vaccines Limited5 个研究点分布在 1 个国家目标入组 100 人开始时间: 待定

试验速览

阶段: 3 期
发起方: Bharat Serums and Vaccines Limited
入组人数: 100
试验地点: 5
主要终点: 1. Total number of eggs 2. Total number of mature oocytes retrieved 3. No. of HP FSH vials used 4. Total days of FSH stimulation

This study is a randomised open label multi-centre trial to compare the efficacy and safety of 2 brands of highly purified follicle-stimulating hormone in subjects undergoing their first cycle of invitro fertilization with intracytoplasmic sperm injection (ICSI). The study is being conducted at 5 centres in India. The primary outcomes are total number of eggs, total number of mature oocytes retrieved, no. of HP FSH vials used, total days of FSH stimulation. The secondary outcomes are number of embryos cleaved, clinical pregnancy rate, incidence of severe OHSS - Grade IV to VI and cancellation rate.

•Subjects undergoing first cycle of invitro fertilization with Intracytoplasmic sperm injection (ICSI)
•Subjects aged >18 and <35 years
•Normogonadotrophic subjects with normal FSH and LH levels
•Semen parameters compatible with Intracytoplasmic sperm injection (ICSI)
•Hysterosalpingography or hysteroscopy documenting a uterus consistent with expected normal function
•Transvaginal ultrasound documenting the presence of both ovaries, without evidence of abnormality.

1. Total number of eggs 2. Total number of mature oocytes retrieved 3. No. of HP FSH vials used 4. Total days of FSH stimulation

时间窗: End of study - 6 weeks

1. Number of embryos cleaved 2. Clinical pregnancy rate 3. Incidence of severe OHSS - Grade IV to VI 4. Cancellation Rate(End of study - 6 weeks)

发起方

申办方类型

Pharmaceutical industry-Indian

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