Safety of Ovaleap® (Follitropin Alfa) in Infertile Women Undergoing Superovulation for Assisted Reproductive Technologies: A Multinational Comparative, Prospective Cohort Study.


Journal

Frontiers in endocrinology
ISSN: 1664-2392
Titre abrégé: Front Endocrinol (Lausanne)
Pays: Switzerland
ID NLM: 101555782

Informations de publication

Date de publication:
2021
Historique:
received: 23 11 2020
accepted: 15 02 2021
entrez: 5 4 2021
pubmed: 6 4 2021
medline: 28 12 2021
Statut: epublish

Résumé

Ovaleap Safety of Ovaleap A total of 408 women who were administered Ovaleap Findings from the SOFIA study indicate that the incidence proportions of OHSS and OHSS severity, as well as pregnancy and live birth rates, are similar between Ovaleap

Sections du résumé

Background
Ovaleap
Methods
Safety of Ovaleap
Results
A total of 408 women who were administered Ovaleap
Conclusions
Findings from the SOFIA study indicate that the incidence proportions of OHSS and OHSS severity, as well as pregnancy and live birth rates, are similar between Ovaleap

Identifiants

pubmed: 33815290
doi: 10.3389/fendo.2021.632674
pmc: PMC8010350
doi:

Substances chimiques

Follicle Stimulating Hormone, Human 0
Recombinant Proteins 0
follitropin alfa 0
Follicle Stimulating Hormone 9002-68-0

Types de publication

Comparative Study Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

632674

Informations de copyright

Copyright © 2021 Kaplan, Levy-Toledano, Davies, Roy, Howles and Lass.

Déclaration de conflit d'intérêts

SK is an employee of Teva Pharmaceuticals Industries Ltd. RL-T is a consultant in RLT Media Consulting. RL-T was a consultant to Teva Pharmaceutical Industries Ltd. (and/or its affiliates), and then to Theramex at the time of study conduct. MD and DR are employees of the Drug Safety Research Unit (DSRU). The DSRU is an independent, academic research institution, and has received funds from Theramex for consulting on the study. CH and AL are consultants to Theramex.

Références

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Auteurs

Sigal Kaplan (S)

Global Patient Safety & Pharmacovigilance, Teva Pharmaceutical Industries Ltd., Netanya, Israel.

Rachel Levy-Toledano (R)

RLT Media Consulting, Boulogne Billancourt, France.

Miranda Davies (M)

Drug Safety Research Unit, Southampton, United Kingdom.
School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, United Kingdom.

Debabrata Roy (D)

Drug Safety Research Unit, Southampton, United Kingdom.
School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, United Kingdom.

Colin M Howles (CM)

Medical Department, Theramex Ltd., London, United Kingdom.

Amir Lass (A)

Medical Department, Theramex Ltd., London, United Kingdom.

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Classifications MeSH