Document Detail


Luteal phase support in normo-ovulatory women stimulated with clomiphene citrate for intrauterine insemination: need or habit?
MedLine Citation:
PMID:  20719809     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Limited data exist concerning the need for luteal support in clomiphene citrate-stimulated intrauterine insemination (IUI) cycles. The addition of progesterone became an established clinical practice, despite the absence of evidence of effectiveness.
METHODS: A prospective randomized controlled trial was performed in a tertiary referral centre to assess the effect of intravaginal micronized progesterone as luteal support on the probability of ongoing pregnancy in patients stimulated with clomiphene citrate for IUI. Normo-ovulatory women, ≤ 36 years of age, undergoing ovarian stimulation with clomiphene citrate (50 mg) for IUI (n = 468) were randomized during the period from September 2008 to December 2009. Patients were randomized, either to receive luteal phase support (n = 243) in the form of vaginal micronized progesterone in three separate doses (200 mg, 3 times a day), or to the control group who did not receive luteal phase support (n = 225).
RESULTS: Data from 400 women were analysed. Following the first interim analysis, the study was prematurely cancelled as an extremely low total pregnancy rate was found. No difference was observed in ongoing pregnancy between patients who did, or did not, receive vaginal progesterone as luteal support [8.7% (17/196) versus 9.3% (19/204), respectively, P = 0.82; difference -0.6%, 95% confidence interval (CI): -6.4, 5.2]. Additionally, the early pregnancy loss rate did not differ between groups (1.5% progesterone group versus 2% no progesterone group, P = 0.78; difference -0.5%, 95% CI: -3.6, 2.7).
CONCLUSIONS: Routine supplementation of the luteal phase with vaginal progesterone does not seem to improve pregnancy rates in normo-ovulatory women stimulated with clomiphene citrate for IUI. Clinical trials.gov:NCT01046708.
Authors:
D Kyrou; H M Fatemi; H Tournaye; P Devroey
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial     Date:  2010-08-18
Journal Detail:
Title:  Human reproduction (Oxford, England)     Volume:  25     ISSN:  1460-2350     ISO Abbreviation:  Hum. Reprod.     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-09-16     Completed Date:  2011-01-10     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8701199     Medline TA:  Hum Reprod     Country:  England    
Other Details:
Languages:  eng     Pagination:  2501-6     Citation Subset:  IM    
Affiliation:
Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, Brussels 1090, Belgium. mimikyrou@yahoo.gr
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01046708
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MeSH Terms
Descriptor/Qualifier:
Adult
Clomiphene / administration & dosage*
Female
Fertility Agents, Female / administration & dosage*
Humans
Infertility, Female / drug therapy,  therapy*
Insemination, Artificial*
Luteal Phase / drug effects*
Ovulation Induction / methods*
Pregnancy
Pregnancy Rate
Progesterone / administration & dosage
Chemical
Reg. No./Substance:
0/Fertility Agents, Female; 57-83-0/Progesterone; 911-45-5/Clomiphene

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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