Polycystic Ovary Syndrome Clinical Trial
Official title:
Study of Stair-step Clomiphene Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome (PCOS) Compared to Traditional Protocol.
The objective of our study is to evaluate the efficacy of the clomiphene stair-step protocol
to induce ovulation in women with polycystic ovarian syndrome (PCOS) compared to traditional
protocol.
Methods:This was a randomized controlled clinical trial at the Fertility clinic of Al sadder
teaching hospital at Al- Najaf city, Iraq . It included 140 women who met all of the
inclusion criteria, they were divided into two groups; 65 patients for the stair step
protocol and 75 patients for the traditional protocol.
Overall study design This was a randomized clinical trial using toss a coin as randomization
technique carried out on subfertile women attending the Fertility Clinic of AL Sadder
Teaching Hospital at Al- Najaf city, Iraq from May 2010 till May 2011. 170 infertile women
were selected at that time for study participation after their written consent.
Participant, recruitment and randomization:
The diagnostic criteria adopted for PCOS was according to Rotterdam ESHRE/ASRM sponsored PCOS
consensus workshop group, 2004 based on the presence of two of the following three criteria:
i.e. Oligo- and/or anovulation, hyperandrogenism clinical and/or biochemical, Polycystic
ovaries, an ovary with 12 or more follicles measuring 2-9 mm indiameter and increased ovarian
volume (>10 cm3) on transvaginal ultrasound(1) .
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