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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03178500
Other study ID # STAIRSTEP TRIAL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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