A comparative clinical trial to test efficacy and safety of 2 brands of highly purified follicle-stimulating hormone in subjects undergoing IVF
- Registration Number
- CTRI/2010/091/000852
- Lead Sponsor
- Bharat Serums and Vaccines Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
1. Subjects undergoing first cycle of invitro fertilization with Intracytoplasmic sperm injection (ICSI)
2. Subjects aged >18 and <35 years
3. Normogonadotrophic subjects with normal FSH and LH levels
4. Semen parameters compatible with Intracytoplasmic sperm injection (ICSI)
5. Hysterosalpingography or hysteroscopy documenting a uterus consistent with expected normal function
6. Transvaginal ultrasound documenting the presence of both ovaries, without evidence of abnormality
1. Subjects > 35 years of age.
2. Infertility attributable to severe endometriosis (grade III or IV)
3. Subjects with previous failed IVF or IVF with ICSI cycle
4. Pelvic pathology that would compromise invitro fertilization (IVF) success
5. Tumors and malformation of sexual organs incompatible with pregnancy
6. Hypersensitivity to any trial product
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method