An Early Phase 1 interventional study of Metformin and Placebo in Infertility, sponsored by Elham Raafat. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-21.
Sponsored by Elham Raafat · Early Phase 1, Interventional, and Treatment
The aim of this study is to asses the effect of metformin on clinical pregnancy rate in women with unexplained infertility (randomized controlled trial).
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 .
Metformin is usually used with induction regimen in patients with PCOS as it improves ovulation rate by direct effect on ovarian tissue,Metformin will be used in combination with clomiphene citrate in women with unexplained infertility with previous failed cycle to asses its efficacy on clinical pregnancy rate.
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.
2,540 studies on the registry are indexed under Infertility; 405 are open to participants now.
This study's planned enrollment of 170 is above the median of 120 across 1,722 interventional studies indexed under Infertility.
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Exclusion Criteria:
Will receive metformin plus clomiphene citrate
Drug: Metformin · Drug: Clomiphene Citrate
Will receive placebo plus clomiphene citrate.
Drug: Placebo · Drug: Clomiphene Citrate
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.
Also known as: glucophage
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.
50 mg of clomiphene citrate will be given starting day 2 of menstrual cycle for 5 days
Also known as: Clomid
Clinical pregnancy rate
Diagnosis of pregnancy by transvaginal ulterasound
Time frame: one cycle for each woman (28 days in average)
Plan to share: No
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This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metformin