Evidence map›Paper›PMID 31007468›Full record

ArticleJournal of human reproductive sciences

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

Abha Majumdar, Rekha Sachan, Yogeshwar S Nandanwar, Rahul V Mayekar, Neelu Soni, Manish R Banker, Rajan S Vaidya, Manjeet Arora, Girish P Godbole, Gautam V Daftary and 2 more

Open access · diamondAbstract read
In one paragraph

Article in Journal of human reproductive sciences. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Synchronised approach for intrauterine insemination in subfertile couples.The Cochrane database of systematic reviews · 2025
    Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 1 country.

Abha MajumdarDepartment of Obstetrics and Gynaecology, Sir Ganga Ram Hospital, New Delhi, India.
Rekha SachanDepartment of Obstetrics and Gynaecology, King George's Medical University, Lucknow, Uttar Pradesh, India.
Yogeshwar S NandanwarDepartment of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, Maharashtra, India.
Rahul V MayekarDepartment of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, Maharashtra, India.
Neelu SoniDepartment of Obstetrics and Gynaecology, Choithram Hospital and Research Centre, Indore, Madhya Pradesh, India.
Manish R BankerNova IVI Fertility, Ahmedabad, Gujarat, India.
Rajan S VaidyaDepartment of Obstetrics and Gynaecology, Nowrosjee Wadia Maternity Hospital, Mumbai, Maharashtra, India.
Manjeet AroraDepartment of Obstetrics and Gynaecology, Batra Hospital and Medical Research Centre, New Delhi, India.
Girish P GodboleDepartment of Obstetrics and Gynaecology, Deenanath Mangeshkar Hospital and Research Centre, Pune, Maharashtra, India.
Gautam V DaftaryResearch and Development, Bharat Serums and Vaccines Limited, Navi Mumbai, Maharashtra, India.
Ganesh H DivekarDepartment of Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines Limited, Navi Mumbai, Maharashtra, India.
James JohnDepartment of Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines Limited, Navi Mumbai, Maharashtra, India.
Bharat Serums and Vaccines (India) · INLokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College · INBai Jerbai Wadia Hospital for Children · INBatra Hospital and Medical Research Centre · INBloom Fertility Centre · INChoithram Hospital and Research Centre · INDeenanath Mangeshkar Hospital and Research Center · INKing George's Medical University · INSir Ganga Ram Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextA new indigenous recombinant human chorionic gonadotropin (r-hCG) has been developed in India with a comparable pharmacological profile to that of Ovitrelle

aimsThis 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

designRandomized (2:1), multicenter, open-label, equivalence clinical trial conducted in India. SUBJECTS AND

methodsA 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

resultsWith 144 women in the test group and 73 in the comparator group, the ovulation rate (85.4% vs. 78.1%;

conclusionsThe new preparation of r-hCG was equivalent to the conventional preparation of r-HCG in the induction of ovulation in patients undergoing IUI.

Indexed as

Human chorionic gonadotropinintrauterine inseminationovulation inductionrecombinant

Identifiers

PMID31007468
PMCPMC6472201
OpenAlexW2939928420

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.