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

NCT01953796 | Completed DMC

• 1 other identifier: Kufa university
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovarian Syndrome stair step traditional protocol

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Study of Stair-step Clomiphene Protocol

EXPERIMENTAL

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

Traditional Protocol.

ACTIVE COMPARATOR

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

Interventions

clomiphene DRUG

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.

Also known as: clomid

Study of Stair-step Clomiphene Protocol; Traditional Protocol.

Eligibility Criteria

• Age: 21 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Kufa University: lead

Study Sites (1)

Basima Al- Ghazali

Najaf, Kufa, 00964, Iraq

Location

Related Publications (2)

• clomiphene protocol in polycystic ovarian syndrome: Hurst et al.

  BACKGROUND

• Hurst BS, Hickman JM, Matthews ML, Usadi RS, Marshburn PB. Novel clomiphene "stair-step" protocol reduces time to ovulation in women with polycystic ovarian syndrome. Am J Obstet Gynecol. 2009 May;200(5):510.e1-4. doi: 10.1016/j.ajog.2008.10.031. Epub 2008 Dec 27.

  PMID: 19114272 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• basima sh jabbar, consultant

  medical college/ kufa university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kufa university- Iraq

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: October 1, 2013
• Study Start: May 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

IR (1)