A Multicenter, Randomized, Equivalence Trial of a New Recombinant Human Chorionic Gonadotropin Preparation versus Ovitrelle

A new indigenous recombinant human chorionic gonadotropin (r-hCG) has been developed in India with a comparable pharmacological profile to that of Ovitrelle This study aims to compare the efficacy and safety of the new r-hCG with that of Ovitrelle for induction of ovulation in women undergoing intrauterine insemination (IUI). Randomized (2:1), multicenter, open-label, equivalence clinical trial conducted in India. A total of 217 women, aged 20-37 years, undergoing IUI were administered the new r-hCG (test) 250 mcg or Ovitrelle 250 mcg (comparator) after ovarian stimulation with gonadotropins. The ovulation rate was compared as the primary outcome. In addition, pregnancy rates, incidence of adverse events (AEs), and development of immunogenicity were assessed. Statistical Analysis Used: The ovulation and pregnancy rates were compared using Chi-squared test with statistical significance at With 144 women in the test group and 73 in the comparator group, the ovulation rate (85.4% vs. 78.1%; The new preparation of r-hCG was equivalent to the conventional preparation of r-HCG in the induction of ovulation in patients undergoing IUI.

Déclaration de conflit d'intérêts

Dr. Gautam Daftary is a Managing Director of Bharat Serums and Vaccines Limited. Dr. Ganesh Divekar and Dr. James John are full-time paid employees of Bharat Serums and Vaccines Limited. Bharat Serums and Vaccines funded the entire study.