Comparison of Three Different Strategies for Treating Infertility in Anovulatory Women With Polycystic Ovary Syndrome: a Multicentre Randomized Controlled Clinical Trial
Sponsor study identifier
interventional
552
1 country
3
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedAnovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Even if several first-step treatments have been proposed for anovulatory infertile PCOS patients, very few data are available in literature regarding the best integrated strategy. In fact, a single compound could be effective as first-step approach but not or less useful when integrated in a more complex strategy. The goal of the current protocol will be to compare three different strategies for treating anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy rate.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
April 13, 2007
Actual (reported)April 18, 2007
Actual (reported)December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Multiple pregnancy rate
9 months
Ovulation rate
15 months
Pregnancy rate
15 months
Abortion rate
15 months
Live-birth rate
24 months
Adverse-events
15
clomiphene followed by clomiphene plus metformin followed by gonadotropins
metformin followed by metformin plus clomiphene followed by gonadotropins
metformin plus clomiphene followed by gonadotropins
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record"Pugliese" Hospital
Catanzaro, 88100, Italy
"Pugliese" Hospital
Catanzaro, 88100, Italy
Palomba S, Orio F Jr, Falbo A, Manguso F, Russo T, Cascella T, Tolino A, Carmina E, Colao A, Zullo F. Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Jul;90(7):4068-74. doi: 10.1210/jc.2005-0110. Epub 2005 Apr 19.
Moll E, Bossuyt PM, Korevaar JC, Lambalk CB, van der Veen F. Effect of clomifene citrate plus metformin and clomifene citrate plus placebo on induction of ovulation in women with newly diagnosed polycystic ovary syndrome: randomised double blind clinical trial. BMJ. 2006 Jun 24;332(7556):1485. doi: 10.1136/bmj.38867.631551.55. Epub 2006 Jun 12.
Stefano Palomba, MD
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
First Submitted
April 13, 2007
First Posted
April 18, 2007
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Estimated (date passed)Contact the study team to confirm eligibility.
Pugliese-Ciaccio Hospital
Catanzaro, 88100, Italy
Legro RS, Barnhart HX, Schlaff WD, Carr BR, Diamond MP, Carson SA, Steinkampf MP, Coutifaris C, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Giudice LC, Leppert PC, Myers ER; Cooperative Multicenter Reproductive Medicine Network. Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Engl J Med. 2007 Feb 8;356(6):551-66. doi: 10.1056/NEJMoa063971.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 9, 2013
Record last verified: 2013-04
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Source: ClinicalTrials.gov.
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