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

Kufa University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: clomiphene

Study type: Interventional

Funder types: Other

Identifiers

NCT01953796

Kufa university

Details and patient eligibility

About

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) .

Enrollment: 140 patients

Sex: Female

Ages: 21 to 34 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Study of Stair-step Clomiphene Protocol

Experimental group

Description:

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.

Treatment:

Drug: clomiphene

Traditional Protocol.

Active Comparator group

Description:

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.

Treatment:

Drug: clomiphene