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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Basima Shamkhi Al-Ghazali, Kufa University
ClinicalTrials.gov Identifier:
NCT01953796
First received: September 25, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Drug: clomiphene

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Stair-step Clomiphene Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome (PCOS) Compared to Traditional Protocol.

Resource links provided by NLM:


Further study details as provided by Kufa University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    140 patients who met all of the inclusion criteria were divided into two main groups, Induction of ovulation for both protocols was performed.


Enrollment: 140
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: clomid

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

Ages Eligible for Study:   21 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01953796

Locations
Iraq
Basima Al- Ghazali
Najaf, Kufa, Iraq, 00964
Sponsors and Collaborators
Kufa University
Investigators
Principal Investigator: basima sh jabbar, consultant medical college/ kufa university
  More Information

Publications:
Hurst BS, Hichman JM. mathews ML, Novel clomiphene stair- step protocol for ovulation induction in women withpolycystic ovarian syndrome Am J obstet gynecel;2009,200-510.

Responsible Party: Basima Shamkhi Al-Ghazali, Kufa university- Iraq, Kufa University
ClinicalTrials.gov Identifier: NCT01953796     History of Changes
Other Study ID Numbers: Kufa university
Study First Received: September 25, 2013
Last Updated: September 25, 2013
Health Authority: Iraq: Ethics Committee

Keywords provided by Kufa University:
Polycystic Ovarian Syndrome stair step traditional protocol

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Clomiphene
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on April 17, 2014