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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Clomifene citrate or low-dose FSH for the first-line treatment of infertile women with anovulation associated with polycystic ovary syndrome: A prospective randomized multinational study
Human Reproduction, Volume 27, No. 2, Year 2012
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Description
BACKGROUND: Clomifene citrate (CC) is accepted as the first-line method for ovulation induction (OI) in patients with polycystic ovary syndrome (PCOS) associated with infertility owing to anovulation. Low-dose FSH has been reserved for women failing to conceive with CC. In this RCT, we tested the hypothesis that pregnancy rate (PR) and live birth rates (LBR) are higher after OI with low-dose FSH than with CC as first-line treatment. METHODS: Infertile women (<40 years old) with PCOS-related anovulation, without prior OI treatment, attending 10 centres in Europe/South America were randomized to OI with either CC (50-150 mg/day for 5 days) or FSH (starting dose 50 IU) for up to three treatment cycles. The primary outcome was clinical PR. RESULTS: Patients (n = 302) were randomized to OI with FSH (n = 132 women; 288 cycles) or CC (n = 123; 310 cycles). Per protocol analysis revealed that reproductive outcome was superior after OI with FSH than with CC with respect to PR per first cycle [30 versus 14.6%, respectively, 95 confidence interval (CI) 5.3-25.8, P = 0.003], PR per woman, (58 versus 44% of women, 95% CI 1.5-25.8, P = 0.03), LBR per woman (52 versus 39%, 95% CI 0.4-24.6, P = 0.04), cumulative PR (52.1 versus 41.2%, P = 0.021) and cumulative LBR (47.4 versus 36.9%, P = 0.031), within three cycles of OI. CONCLUSIONS: Pregnancies and live births are achieved more effectively and faster after OI with low-dose FSH than with CC. This result has to be balanced by convenience and cost in favour of CC. FSH may be an appropriate first-line treatment for some women with PCOS and anovulatory infertility, particularly older patients. © The Author 2011. Published by Oxford University Press. All rights reserved.
Authors & Co-Authors
Anderson, Richard A.A.
United Kingdom, Edinburgh
The University of Edinburgh
Balen, Adam H.
United Kingdom, Leeds
Leeds Teaching Hospitals Nhs Trust
D'Hooghe, Thomas Maria
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Rajkhowa, Madhurima
United Kingdom, Dundee
Ninewells Hospital
Lambalk, C. B.Nils
Netherlands, Amsterdam
Amsterdam Umc - Vrije Universiteit Amsterdam
Statistics
Citations: 78
Authors: 5
Affiliations: 7
Identifiers
Doi:
10.1093/humrep/der401
ISSN:
02681161
Research Areas
Maternal And Child Health
Sexual And Reproductive Health
Study Design
Randomised Control Trial
Cohort Study
Study Approach
Quantitative
Participants Gender
Female