Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility
NCT ID: NCT03681197
Last Updated: 2019-03-21
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
EARLY_PHASE1
170 participants
INTERVENTIONAL
2018-06-15
2019-05-31
Brief Summary
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This study will be conducted in infertility clinic,Ain Shams university maternity hospital,170 women with unexplained infertility will be enrolled in this study.
Statistical analysis of the data will be performed .
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Detailed Description
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Study will be conducted in infertility clinic,Ain Shams university maternity hospital.Study population comprises women with unexplained infertility aged 20-35 years with total sample size of 170 who willbe randomized into two groups with 85 women in each group.
Group A:is case group who will receive metformin plus clomiphene citrate. Group B:is control group who will receive clomiphene citrate plus placebo. Metformin will be started at time of booking and will be continued till pregnancy is confirmed in a dose of 850 mg twice daily in form of tablet.
Vaginal ultrasound is done for all in day 2 to exclude presence of ovarian cyst and to identify normal appearance of ovaries,then folliculometry on day 9 followed by serial folliculometry every other day till reaching dominant follicle 18 mm or more where HCG intramuscular injection will be given in a dose of 10000 iu .
serum pregnancy test will be done after 16 days. Transvaginal ulterasound will be done on day 35.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Metformin Group
Will receive metformin plus clomiphene citrate
Metformin
Metformin 850 mg tablet will be started twice daily immediately at booking time and continued with induction by clomiphene citrate, it will be stopped once pregnancy is confirmed.
Clomiphene Citrate
50 mg of clomiphene citrate will be given starting day 2 of menstrual cycle for 5 days
Placebo
Will receive placebo plus clomiphene citrate.
Placebo
In placebo group,placebo will be strted twice daily at booking time and continued with induction by clomiphene citrate, it will be stopped once pregnancy is confirmed.
Clomiphene Citrate
50 mg of clomiphene citrate will be given starting day 2 of menstrual cycle for 5 days
Interventions
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Metformin
Metformin 850 mg tablet will be started twice daily immediately at booking time and continued with induction by clomiphene citrate, it will be stopped once pregnancy is confirmed.
Placebo
In placebo group,placebo will be strted twice daily at booking time and continued with induction by clomiphene citrate, it will be stopped once pregnancy is confirmed.
Clomiphene Citrate
50 mg of clomiphene citrate will be given starting day 2 of menstrual cycle for 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI 20-\<30
* FSH 12 IU/L or less
* Normal transvaginal ulterasound(normal uterus and ovaries with no congenital anomalies).
* Patent fallopian tubes assesd by hysterosalpingogram or laparoscopy.
* Normal semen analysis.
* Infertile women with history of previous failed induction cycle.
Exclusion Criteria
* Women with BMI equal to or more than 30.
* Uncorrected congenital or acquired uterine anomaly.
* Other causes of infertility rather than unexplained infertility.
* Patient with Diabetes Mellitus.
20 Years
35 Years
FEMALE
Yes
Sponsors
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Elham Raafat
OTHER
Responsible Party
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Elham Raafat
resident of obstetric and gynecology
Principal Investigators
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Sarah S Moawad, Lecturer
Role: STUDY_DIRECTOR
Ain Shams Maternity Hospital
Ahmed M Bahaa Eldin, Professor
Role: STUDY_DIRECTOR
Ain Shams Maternity Hospital
Hisham M Fathy, Professor
Role: STUDY_DIRECTOR
Ain Shams Maternity Hospital
Locations
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Elham Raafat Mohamed
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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1982
Identifier Type: -
Identifier Source: org_study_id
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