Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility

Infertility Clinical Trial

Official title:

Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03681197
• Other study ID #: 1982
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 15, 2018
• Est. completion date: May 2019

Study information

• Verified date: March 2019
• Source: Ain Shams University
• Contact: Elham R Mohamed
• Phone: 0021156230921
• Email: Elhamraafat[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 .

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: May 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age 20-35 years old.

• 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 younger than 20 or elder than 35 years old.

• 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.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Egypt	Elham Raafat Mohamed	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Elham Raafat

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Diagnosis of pregnancy by transvaginal ulterasound	one cycle for each woman (28 days in average)