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J Hum Reprod Sci. 2019 Oct-Dec;12(4):303-309. doi: 10.4103/jhrs.JHRS_33_19. Epub 2019 Dec 17.

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.

Author information

1
Department of Obstetrics and Gynaecology, Sir Ganga Ram Hospital, New Delhi, India.
2
Center for Assisted Reproduction, National Hospital of Obstetrics and Gynecology, Hanoi, Vietnam.
3
Infertility Department, Hung Vuong Hospital, Ho Chi Minh City, Vietnam.
4
Department of Obstetrics and Gynaecology, Inamdar Multispeciality Hospital, Pune, Maharashtra, India.
5
Department of Obstetrics and Gynaecology, Apollo Hospitals, Bengaluru, Karnataka, India.
6
Department of Obstetrics and Gynaecology, ILS Hospitals, Kolkata, West Bengal, India.
7
Department of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, Maharashtra, India.
8
Department of Obstetrics and Gynaecology, Apollo BGS Hospitals, Mysore, Karnataka, India.
9
Department of Obstetrics and Gynaecology, Choithram Hospital and Research Centre, Indore, Madhya Pradesh, India.
10
Department of Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines Limited, Navi Mumbai, Maharashtra, India.

Abstract

Context:

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

Aims:

The 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 Design:

Prospective, multicenter study conducted at reproductive medicine clinics in India and Vietnam.

Materials and Methods:

A total of 285 women, aged 20-40 years, undergoing 354 COS cycles for either intrauterine insemination (IUI) or in vitro fertilization (IVF) were studied. The primary outcome measure was the incidence of development of anti-drug antibodies (ADA) and their neutralization potential. Other outcome measures were follicle development, dose and duration of r-hFSH, positive serum pregnancy test, clinical pregnancy, cycle cancellation, and adverse events (AEs).

Statistical Analysis Used:

A sample size of 250 was planned. Descriptive statistics are presented.

Results:

Four 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.

Conclusions:

The 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.

KEYWORDS:

Antidrug antibody; assisted reproductive technique; immunogenicity; in vitro fertilization; infertility; intrauterine insemination

Conflict of interest statement

Ganesh H. Divekar and James John are employees of Bharat Serums and Vaccines Limited, India.

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