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

September 25, 2013 updated by: Basima Shamkhi Al-Ghazali, Kufa University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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) .

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Kufa
      • Najaf, Kufa, Iraq, 00964
        • Basima Al- Ghazali

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 32 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study of Stair-step Clomiphene Protocol
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
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.
Other Names:
  • clomid
Active Comparator: Traditional Protocol.
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
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.
Other Names:
  • clomid

What is the study measuring?

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.
Time Frame: 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kufa University

Investigators

  • Principal Investigator: basima sh jabbar, consultant, medical college/ kufa university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

September 25, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Estimate)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 25, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kufa university

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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