Clinical trial NCT01953796: Clomiphene Stair-Step Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome
Official title: Study of Stair-step Clomiphene Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome (PCOS) Compared to Traditional Protocol.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovarian Syndrome stair step traditional protocol
Lead sponsor: Kufa University
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 140
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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) .

Eligibility 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.

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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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Primary outcomes:
measure: The time to ovulation with the stair step protocol was 21-28 days as compared with the traditional protocol which was 42 -70 days.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Najaf
country: Iraq
facility: Basima Al- Ghazali
state: Kufa
Study officials:
affiliation: medical college/ kufa university
name: basima sh jabbar, consultant
role: PRINCIPAL_INVESTIGATOR
References:
citation: clomiphene protocol in polycystic ovarian syndrome: Hurst et al.
citation: Hurst BS, Hickman JM, Matthews ML, Usadi RS, Marshburn PB. Novel clomiphene "stair-step" protocol reduces time to ovulation in women with polycystic ovarian syndrome. Am J Obstet Gynecol. 2009 May;200(5):510.e1-4. doi: 10.1016/j.ajog.2008.10.031. Epub 2008 Dec 27.