Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-02-01
2018-07-31
Brief Summary
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Detailed Description
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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 .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Traditional
Clomiphene citrate (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.
Clomiphene Citrate 50mg
stair-step clomiphene adminstration
Stair step protocol
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
Clomiphene Citrate 50mg
stair-step clomiphene adminstration
Interventions
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Clomiphene Citrate 50mg
stair-step clomiphene adminstration
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI/m2) 26-35 kg/m2
* Normal hystrosalpingogram (HSG).
* Normal Prolactin level.
* Normal semen analysis.
Exclusion Criteria
* Other factors infertility.
* AUTOimmune diseases as thyroid disorders and systemic lupus erythematosus.
20 Years
35 Years
FEMALE
Yes
Sponsors
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Ain Shams Maternity Hospital
OTHER
Responsible Party
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ADEL SHAFIK SALAH EL-DIN
Assistant professor
Principal Investigators
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Adel S Salah El-Din, MD
Role: STUDY_DIRECTOR
Assistant Proffesor
Locations
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Ain Shams University Maternity Hospital
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STAIRSTEP TRIAL
Identifier Type: -
Identifier Source: org_study_id
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