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.

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/10/007367

Enrollment

116

Registered

2016-10-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Undergoing Assisted Reproductive Technology

Interventions

Intervention1: r-hFSH: Recombinant Human Follicular Stimulating Hormone of Cadila Healthcare Limited, India Control Intervention1: Gonal-F: Gonal-F of Merck Specialties Pvt. Ltd.

Eligibility

Inclusion criteria

Inclusion criteria: 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 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

Exclusion criteria

Exclusion criteria: 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 13. Positive Pregnancy test at screening

Design outcomes

Primary

Measure	Time frame
Number of Oocytes retrievedTimepoint: Number of Oocytes retrieved	—

Secondary

Measure	Time frame
â?¢ Biochemical pregnancy rate after 2 weeks of embryo transfer â?¢ Total dose of r-hFSH required â?¢ Number of days of r-hFSH stimulation â?¢ Number and size distribution of follicles at the day of ovulation induction. â?¢ Percentage of patients with need to increase or lower the dose of r-hFSH â?¢ Number of good quality oocytes Timepoint: NIL	—

Countries

India

Contacts

Public ContactDr Dharmesh Domadia

Cliantha Research Limited

ddomadia@claintha.in9879590828

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026