A comparative clinical trial to test efficacy and safety of 2 brands of highly purified human menopausal gonadotropins in subjects undergoing their first cycle of IVF
Phase 3
- Registration Number
- CTRI/2009/091/000854
- 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
Inclusion Criteria
1. Subjects undergoing first cycle of invitro fertilization with Intracytoplasmic sperm injection (ICSI)
2. Subjects aged ≤ 35 years
3. BMI between 18 and 30 kg/m2
4. subjects with normal FSH and LH levels
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
Exclusion Criteria
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. Polycystic ovary disease
5.Undiagnosed vaginal bleeding
6. Tumors and malformation of sexual organs incompatible with pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Total number of eggs <br>2. Total number of mature oocytes retrieved<br>3. No. of HP HMG vials used<br>4. Total days of HMG stimulation <br>Timepoint: 6 weeks
- Secondary Outcome Measures
Name Time Method 1. Number of embryos cleaved<br>2. Clinical pregnancy rate<br>3. Incidence of severe OHSS - Grade IV to VI<br>4. Cycle Cancellation Rate<br>Timepoint: 6 weeks