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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.
Full description
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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Inclusion and exclusion criteria
Inclusion Criteria:Female in the reproductive age who is subfertile with the diagnosis of polycystic ovarian syndrome, serum FSH≤10 mIU/ml with spontaneous menses or positive bleeding response to progestagen withdrawal.
Exclusion Criteria:Male factor (moderate to severe) infertility, bilateral tubal blockage diagnosed by hystrosalpingographgy or laparoscopy and patients on metformin or other medication.
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140 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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