PMID- 31007468
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220408
IS  - 0974-1208 (Print)
IS  - 1998-4766 (Electronic)
IS  - 1998-4766 (Linking)
VI  - 12
IP  - 1
DP  - 2019 Jan-Mar
TI  - A Multicenter, Randomized, Equivalence Trial of a New Recombinant Human Chorionic 
      Gonadotropin Preparation versus Ovitrelle((R)) for Ovulation in Women Undergoing 
      Intrauterine Insemination Following Ovarian Stimulation.
PG  - 53-58
LID - 10.4103/jhrs.JHRS_101_18 [doi]
AB  - CONTEXT: A new indigenous recombinant human chorionic gonadotropin (r-hCG) has 
      been developed in India with a comparable pharmacological profile to that of 
      Ovitrelle((R)) (Merck Serono). AIMS: 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). SETTINGS AND DESIGN: Randomized 
      (2:1), multicenter, open-label, equivalence clinical trial conducted in India. 
      SUBJECTS AND METHODS: 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 P < 0.05. RESULTS: With 144 women in the test group 
      and 73 in the comparator group, the ovulation rate (85.4% vs. 78.1%; P = 0.17) 
      and pregnancy rate (serum beta hCG test) (11.8% vs. 12.3%; P = 0.91) were similar in 
      both groups. A total of 15 AEs were reported (11 in the test r-hCG group and 4 in 
      the comparator group) in 11 women; none of these were serious, and all were 
      judged to be unrelated to the study drug. No subject developed immunogenic 
      reaction to the test drug. CONCLUSIONS: The new preparation of r-hCG was 
      equivalent to the conventional preparation of r-HCG in the induction of ovulation 
      in patients undergoing IUI.
FAU - Majumdar, Abha
AU  - Majumdar A
AD  - Department of Obstetrics and Gynaecology, Sir Ganga Ram Hospital, New Delhi, 
      India.
FAU - Sachan, Rekha
AU  - Sachan R
AD  - Department of Obstetrics and Gynaecology, King George's Medical University, 
      Lucknow, Uttar Pradesh, India.
FAU - Nandanwar, Yogeshwar S
AU  - Nandanwar YS
AD  - Department of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical 
      College and General Hospital, Mumbai, Maharashtra, India.
FAU - Mayekar, Rahul V
AU  - Mayekar RV
AD  - Department of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical 
      College and General Hospital, Mumbai, Maharashtra, India.
FAU - Soni, Neelu
AU  - Soni N
AD  - Department of Obstetrics and Gynaecology, Choithram Hospital and Research Centre, 
      Indore, Madhya Pradesh, India.
FAU - Banker, Manish R
AU  - Banker MR
AD  - Nova IVI Fertility, Ahmedabad, Gujarat, India.
FAU - Vaidya, Rajan S
AU  - Vaidya RS
AD  - Department of Obstetrics and Gynaecology, Nowrosjee Wadia Maternity Hospital, 
      Mumbai, Maharashtra, India.
FAU - Arora, Manjeet
AU  - Arora M
AD  - Department of Obstetrics and Gynaecology, Batra Hospital and Medical Research 
      Centre, New Delhi, India.
FAU - Godbole, Girish P
AU  - Godbole GP
AD  - Department of Obstetrics and Gynaecology, Deenanath Mangeshkar Hospital and 
      Research Centre, Pune, Maharashtra, India.
FAU - Daftary, Gautam V
AU  - Daftary GV
AD  - Research and Development, Bharat Serums and Vaccines Limited, Navi Mumbai, 
      Maharashtra, India.
FAU - Divekar, Ganesh H
AU  - Divekar GH
AD  - Department of Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines 
      Limited, Navi Mumbai, Maharashtra, India.
FAU - John, James
AU  - John J
AD  - Department of Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines 
      Limited, Navi Mumbai, Maharashtra, India.
LA  - eng
PT  - Journal Article
PL  - India
TA  - J Hum Reprod Sci
JT  - Journal of human reproductive sciences
JID - 101473512
PMC - PMC6472201
OTO - NOTNLM
OT  - Human chorionic gonadotropin
OT  - intrauterine insemination
OT  - ovulation induction
OT  - recombinant
COIS- 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.
EDAT- 2019/04/23 06:00
MHDA- 2019/04/23 06:01
PMCR- 2019/01/01
CRDT- 2019/04/23 06:00
PHST- 2019/04/23 06:00 [entrez]
PHST- 2019/04/23 06:00 [pubmed]
PHST- 2019/04/23 06:01 [medline]
PHST- 2019/01/01 00:00 [pmc-release]
AID - JHRS-12-53 [pii]
AID - 10.4103/jhrs.JHRS_101_18 [doi]
PST - ppublish
SO  - J Hum Reprod Sci. 2019 Jan-Mar;12(1):53-58. doi: 10.4103/jhrs.JHRS_101_18.