Real-world observational study to capture practice pattern of controlled ovarian stimulation in the in vitro-fertilization and embryo transfer or intracytoplasmic sperm injection-2


  • Vivek Sharma Medical Affairs, Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India
  • Vishal Dave Medical Affairs, Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India
  • Sonal Mehta Medical Affairs, Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India
  • Ankita Shah Biostatistics and Programming, Lambda Therapeutic Research Ltd., Ahmedabad, Gujarat, India



COS, rFSH, In vitro-fertilization, Controlled ovarian stimulation


Background: The objective of the study was to evaluate the practice patterns of controlled ovarian stimulation (COS) in patients who underwent in vitro-fertilization and embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI).

Methods: In REAL-COS (REAL-world observational study to capture practice pattern of COS in IVF-ET/ ICSI cycle) study, data was collected by 138 clinicians across India between April 2021 and March 2022 in a retrospective manner.

Results: Data of 1651 subfertility female patients were evaluated. The mean (SD) age was 31.8 (3.9) years and majority (77.8%) of the patients were aged <35 years. Obese patients constituted 28.1% of the total population. The majority (79.5%) of the patients had primary subfertility and the polycystic ovarian syndrome (PCOS) was the most (27.8%) common cause of subfertility. Nearly equal percent of patients were treated with frozen or fresh embryo transfer. Most (~96%) of the patients received GnRH antagonist protocol wherein cetrorelix acetate was the most common drug (98.7%) while ~4% patients received GnRH agonist protocol wherein luprorelin was the most common one (83%). The most commonly used gonadotropin was recombinant follicle stimulating hormone alone therapy (rFSH, 49.2%). Majority (51.8%) of the patients were initiated at 225 IU dose of gonadotropin for COS. For ovulation trigger, human chorionic gonadotropin (hCG) was used in majority (59%) of the cases. Treatment with rFSH alone therapy resulted in max mean no. of oocytes and mean metaphase-II oocytes as compared with other treatments.

Conclusions: This real-world observational study reports primary subfertility as the major reason for IVF-ET/ICSI in the study population. The GnRH antagonist protocol was followed by most of the clinicians participating in this study. rFSH was the most commonly used gonadotropin. rFSH alone therapy yielded the greatest number of oocytes and metaphase II oocytes versus other treatments.


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