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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01953796

Acronym

PCOSCCTvUSS

Enrollment

140

Registered

2013-10-01

Start date

2010-05-31

Completion date

2011-05-31

Last updated

2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovarian Syndrome stair step traditional protocol

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) .

Interventions

DRUGclomiphene

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 34 Years

Healthy volunteers

Yes

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. \-

Design outcomes

Primary

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

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026