Evidence map›Paper›PMID 32038080›Full record

ArticleJournal of human reproductive sciences

A Multicenter Phase IV Study to Investigate the Immunogenicity of Recombinant Human Follicle-Stimulating Hormone and Its Impact on Clinical Outcomes in Females Undergoing Controlled Ovarian Stimulation.

Abha Majumdar, Le Hoang, Ly T Loc, Padma Srivastava, Chitra Ramamurthy, Ratnabali Chakravorty, Yogeshwar S Nandanwar, M D Rashmi, Rahul V Mayekar, Jayashree Sridhar and 2 more

Open access · diamondAbstract read
PubMed Full text at PMC Publisher
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.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 32% 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, 3 citations in OpenAlex.

  1. Trial
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 7 institutions in 2 countries.

Abha MajumdarDepartment of Obstetrics and Gynaecology, Sir Ganga Ram Hospital, New Delhi, India.
Le HoangCenter for Assisted Reproduction, National Hospital of Obstetrics and Gynecology, Hanoi, Vietnam.
Ly T LocInfertility Department, Hung Vuong Hospital, Ho Chi Minh City, Vietnam.
Padma SrivastavaDepartment of Obstetrics and Gynaecology, Inamdar Multispeciality Hospital, Pune, Maharashtra, India.
Chitra RamamurthyDepartment of Obstetrics and Gynaecology, Apollo Hospitals, Bengaluru, Karnataka, India.
Ratnabali ChakravortyDepartment of Obstetrics and Gynaecology, ILS Hospitals, Kolkata, West Bengal, India.
Yogeshwar S NandanwarDepartment of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, Maharashtra, India.
M D RashmiDepartment of Obstetrics and Gynaecology, Apollo BGS Hospitals, Mysore, Karnataka, India.
Rahul V MayekarDepartment of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, Maharashtra, India.
Jayashree SridharDepartment of Obstetrics and Gynaecology, Choithram Hospital and Research Centre, Indore, Madhya Pradesh, 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.
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College · INBharat Serums and Vaccines (India) · INMidas Multispeciality Hospital · INApollo Hospitals · INChoithram Hospital and Research Centre · INSir Ganga Ram Hospital · INVietnam National Children's Hospital · VN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextTherapeutic proteins can cause immune responses, which may have clinical implications.

aimsThe aim of the study was to assess the immunogenicity of recombinant human follicle-stimulating hormone (r-hFSH), when used for controlled ovarian stimulation (COS). SETTINGS AND

designProspective, multicenter study conducted at reproductive medicine clinics in India and Vietnam. MATERIALS AND

methodsA total of 285 women, aged 20-40 years, undergoing 354 COS cycles for either intrauterine insemination (IUI) or STATISTICAL ANALYSIS USED: A sample size of 250 was planned. Descriptive statistics are presented.

resultsFour patients tested positive for ADA after r-hFSH administration at different time points; all of them tested negative, subsequently. None were found to have neutralization potential. The mean dose and duration of r-hFSH were 816 IU and 8.1 days in IUI and 2183 IU and 9.5 days in IVF, respectively. The serum and clinical pregnancy rates were 12.4% and 11.6% in IUI and 32.7% and 29.9% in IVF cycles, respectively. Seven AEs were reported, including two cases of ovarian hyperstimulation syndrome; two AEs were judged to be serious.

conclusionsThe tested r-hFSH has very low immunogenic potential and did not lead to the development of neutralizing antibodies. The overall efficacy and safety of the drug were in-line with existing literature data, and no specific clinical impact of immunogenicity could be identified.

Indexed as

Antidrug antibodyassisted reproductive techniqueimmunogenicityinfertilityintrauterine inseminationin vitro fertilization

Identifiers

PMID32038080
PMCPMC6937766
OpenAlexW2996148064

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

None linked

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.