Clomiphene Stair-Step Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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) .

Official Title
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Study of Stair-step Clomiphene Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome (PCOS) Compared to Traditional Protocol.

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: clomiphene


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study of Stair-step Clomiphene Protocol<br>50 mg clomiphene given for 5 days beginning on day 2 of the cycle. Tv USS done at days 11-14. When there is no response (no follicle >10 mm), 100 mg clomiphene is initiated immediately for 5 days, and U/S is repeated 1 week after the first tvUSS at day 21. If there is no response, another 150 mg clomiphene is initiated immediately for 5 days and U/S is performed 1week after the second U/S (day28). Ovulation for the stair-step cycles was confirmed by folliculometry (follicle tracing) by tvUSS. | Drug: clomiphene<br>* For both protocols follow up of the follicular growth has been made by frequent tvUSS monitoring, which have the advantage of providing direct information about the size and number of follicle and measurement of endometrial thickness during clomiphene medication.<br>* Other names: clomid;|
| Active Comparator: Traditional Protocol.<br>Clomiphene medication was initiated at day two of the cycle. The starting dose was 50 mg/day for 5 consecutive days. In case of absent response, the patient was treated with 10 mg medroxyprogesterone acetate (MPA) for10 days. Daily doses of clomiphene citrate were increased by 50 mg in the next cycle up to 3 treatment cycle. In each cycle monitoring of follicular growth was done by tvUSS at day 11-14 of each cycle. First ovulation was used as the endpoint and the duration of follow-up was three treatment cycles (up to 150mg). Ovulation was assessed by tvUSS monitoring of follicle growth. | Drug: clomiphene<br>* For both protocols follow up of the follicular growth has been made by frequent tvUSS monitoring, which have the advantage of providing direct information about the size and number of follicle and measurement of endometrial thickness during clomiphene medication.<br>* Other names: clomid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to ovulation with the stair step protocol was 21-28 days as compared with the traditional protocol which was 42 -70 days. | 140 patients who met all of the inclusion criteria were divided into two main groups, Induction of ovulation for both protocols was performed. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovarian Syndrome stair step traditional protocol