Anovulatory Infertility Related to Polycystic Ovary Syndrome Clinical Trial
Official title:
Comparison of Three Different Strategies for Treating Infertility in Anovulatory Women With Polycystic Ovary Syndrome: a Multicentre Randomized Controlled Clinical Trial
Anovulatory 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.
All patients eligible will undergo baseline assessment consisting of antropometric,
hormonal, and ultrasonographic assessments. Successively, patients enrolled will be
allocated in three different strategies (strategy A, B, and C).
A total of 184 infertile PCOS patients per arm will be enrolled and treated with three
different integrated strategies: clomiphene followed by clomiphene plus metformin followed
by gonadotropins (strategy A); metformin followed by metformin plus clomiphene followed by
gonadotropins(strategy B); and metformin plus clomiphene followed by gonadotropins(strategy
C).
In all patients, the same regimen will be used to administered clomiphene, metformin, and
gonadotropins.Both clomiphene and metformin will be administered at incremental doses in
each case.Gonadotropins will be administrated to obtain a controlled ovarian stimulation
using highly purified urinary FSH in a low-dose step-up protocol.
During the study, the clinical and reproductive outcomes, and adverse experiences will be
evaluated in each woman.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment