Clomiphene Citrate Stair-Step Protocol

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

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

Conditions
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Polycystic Ovary

Intervention / Treatment
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* Drug: Clomiphene Citrate 50mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional<br>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. | Drug: Clomiphene Citrate 50mg<br>* stair-step clomiphene adminstration<br>|
| Experimental: Stair step protocol<br>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 | Drug: Clomiphene Citrate 50mg<br>* stair-step clomiphene adminstration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to achieve ovulation | time for ovulation to occur | 20 days | 
| dose of clomiphene to achieve ovulation | the total dose of clomiphene used till ovulation | 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clomiphene citrate, stair- step, poly cystic ovary