Clomiphene Citrate Stair-Step Protocol

Polycystic Ovary Clinical Trial

Official title:

Clomiphene Citrate Stair-step Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03178500
• Other study ID #: STAIRSTEP TRIAL
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: July 2018

Study information

• Verified date: June 2018
• Source: Ain Shams Maternity Hospital
• Contact: Adel S Salah El-Din, MD
• Phone: 01005223586
• Email: shafikadel[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A RCT will be conducted to compare the traditional clomiphene citrate regimens for ovulation induction with the stair-step protocol. Sixty women will be included after obtaining their written informed consent and will be randomized into either of the 2 groups.

Description:

This study is a randomized clinical trial (RCT) will be conducted in Ain Shams University maternity hospital at infertility clinic within a period of 6-8 months.

All patient are previously diagnosed as PCOs according to the Rotterdam conference of 2003.

All patients will be devided according to computer based program into two groups First group:

Patients with traditional protocol

Traditional protocol:

Clomiphene citrate (clomid) (50mg) will be given for 5 days (days 3-7). Transvaginal ultrasound from 9th-20th every other day if ovulation occur the patient will be excluded if no ovulation, we will wait for the next menses and increase the dose to (100mg). if no ovulation occurred increase the dose to (150mg) in the next cycle if no ovulation increase the dose to (200mg) TVUS from 9th-20th ovary other day. If no ovulation we will wait for next cycle and increase the dose to (250mg) and so till 6 cycles .

Second group: Patient with stair step protocol Follicular development will be monitored using transvaginal ultrasound at 11-14 day after (50mg) clomiphene for 5 days if there is no response (no follicle >10mm), so, (100mg) clomiphene will be initiated immediately for 5 days and ultrasound will be repeated 1 week after the first ultrasound. If there is no response, (150mg) clomiphene will be initiated immediately for another 5 days and TV/US will be performed 1 week after the second TV/US .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age between 20-35 years.

• Body mass index (BMI/m2) 26-35 kg/m2

• Normal hystrosalpingogram (HSG).

• Normal Prolactin level.

• Normal semen analysis.

Exclusion Criteria:

• - They underwent ovarian drilling.

• Other factors infertility.

• AUTOimmune diseases as thyroid disorders and systemic lupus erythematosus.

Related Conditions & MeSH terms

• Polycystic Ovary
• Polycystic Ovary Syndrome

Intervention

Drug:
• Clomiphene Citrate 50mg
stair-step clomiphene adminstration

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of the ovulation by transvaginal ultrasound	Follicle suddenly disappears or regresses in size.; Irregular margins.; Intra follicular echos. Follicle suddenly becomes more echogenic.; Free fluid in pouch of douglas.	20 days
Secondary	time to achieve ovulation	time for ovulation to occur	20 days
Secondary	dose of clomiphene to achieve ovulation	the total dose of clomiphene used till ovulation	20 days