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

Polycystic Ovary Syndrome Clinical Trial

— PCOSCCTvUSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953796
• Other study ID #: Kufa university
• Status: Completed
• Phase: N/A
• First received: September 25, 2013
• Last updated: September 25, 2013
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: September 2013
• Source: Kufa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Iraq	Basima Al- Ghazali	Najaf	Kufa

Sponsors (1)

Lead Sponsor	Collaborator
Kufa University

Country where clinical trial is conducted

Iraq, 

References & Publications (2)

Bates GW, Shomento S, McKnight K, McLean HM. Novel clomiphene protocol in polycystic ovarian syndrome: Hurst et al. Am J Obstet Gynecol. 2009 May;200(5):586-7. doi: 10.1016/j.ajog.2009.02.019. — View Citation

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 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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