Phase III Study to Evaluate the Efficacy and Safety of Recombinant Human FSH of Cadila Healthcare Limited, India as compared to Gonal-F Administered Subcutaneously in Female Patients Undergoing Assisted Reproductive Technology.
- Conditions
- Health Condition 1: null- Undergoing AssistedReproductive Technology
- Registration Number
- CTRI/2016/10/007367
- Lead Sponsor
- Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 116
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of Oocytes retrievedTimepoint: Number of Oocytes retrieved
- Secondary Outcome Measures
Name Time Method â?¢Biochemical pregnancy rate after 2 weeks of embryo transfer <br/ ><br>â?¢Total dose of r-hFSH required <br/ ><br>â?¢Number of days of r-hFSH stimulation <br/ ><br>â?¢Number and size distribution of follicles at the day of ovulation induction. <br/ ><br>â?¢Percentage of patients with need to increase or lower the dose of r-hFSH <br/ ><br>â?¢Number of good quality oocytes <br/ ><br>Timepoint: NI