PMID- 32038080 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231027 IS - 0974-1208 (Print) IS - 1998-4766 (Electronic) IS - 1998-4766 (Linking) VI - 12 IP - 4 DP - 2019 Oct-Dec TI - 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. PG - 303-309 LID - 10.4103/jhrs.JHRS_33_19 [doi] AB - 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. CI - Copyright: (c) 2019 Journal of Human Reproductive Sciences. FAU - Majumdar, Abha AU - Majumdar A AD - Department of Obstetrics and Gynaecology, Sir Ganga Ram Hospital, New Delhi, India. FAU - Hoang, Le AU - Hoang L AD - Center for Assisted Reproduction, National Hospital of Obstetrics and Gynecology, Hanoi, Vietnam. FAU - Loc, Ly T AU - Loc LT AD - Infertility Department, Hung Vuong Hospital, Ho Chi Minh City, Vietnam. FAU - Srivastava, Padma AU - Srivastava P AD - Department of Obstetrics and Gynaecology, Inamdar Multispeciality Hospital, Pune, Maharashtra, India. FAU - Ramamurthy, Chitra AU - Ramamurthy C AD - Department of Obstetrics and Gynaecology, Apollo Hospitals, Bengaluru, Karnataka, India. FAU - Chakravorty, Ratnabali AU - Chakravorty R AD - Department of Obstetrics and Gynaecology, ILS Hospitals, Kolkata, West Bengal, 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 - Rashmi, M D AU - Rashmi MD AD - Department of Obstetrics and Gynaecology, Apollo BGS Hospitals, Mysore, Karnataka, 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 - Sridhar, Jayashree AU - Sridhar J AD - Department of Obstetrics and Gynaecology, Choithram Hospital and Research Centre, Indore, Madhya Pradesh, 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 DEP - 20191217 PL - India TA - J Hum Reprod Sci JT - Journal of human reproductive sciences JID - 101473512 PMC - PMC6937766 OTO - NOTNLM OT - Antidrug antibody OT - assisted reproductive technique OT - immunogenicity OT - in vitro fertilization OT - infertility OT - intrauterine insemination COIS- Ganesh H. Divekar and James John are employees of Bharat Serums and Vaccines Limited, India. EDAT- 2020/02/11 06:00 MHDA- 2020/02/11 06:01 PMCR- 2019/10/01 CRDT- 2020/02/11 06:00 PHST- 2019/03/06 00:00 [received] PHST- 2019/06/25 00:00 [revised] PHST- 2019/11/01 00:00 [accepted] PHST- 2020/02/11 06:00 [entrez] PHST- 2020/02/11 06:00 [pubmed] PHST- 2020/02/11 06:01 [medline] PHST- 2019/10/01 00:00 [pmc-release] AID - JHRS-12-303 [pii] AID - 10.4103/jhrs.JHRS_33_19 [doi] PST - ppublish SO - J Hum Reprod Sci. 2019 Oct-Dec;12(4):303-309. doi: 10.4103/jhrs.JHRS_33_19. Epub 2019 Dec 17.