Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility

Sponsor

Elham Raafat (Other)

Overall Status

Unknown status

CT.gov ID

NCT03681197

Collaborator

(none)

170

Enrollment

Location

Arms

10.5

Anticipated Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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 .

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Metformin Drug: Placebo Drug: Clomiphene Citrate	Early Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Each of the consecutive women numbers will be written on sequentially numbered opaque sealed envelope that contains the assignment code.At the time of procedure,the responsible investigator will open the envelope to reveal the assignment,and she will introduce the planned method. Monitoring and follow up will be done. After enrollment,the cases will be randomly allocated into two groups.

Primary Purpose:

Treatment

Official Title:

Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility

Actual Study Start Date :

Jun 15, 2018

Anticipated Primary Completion Date :

Apr 1, 2019

Anticipated Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Metformin Group Will receive metformin plus clomiphene citrate	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. Other Names: glucophage Drug: Clomiphene Citrate 50 mg of clomiphene citrate will be given starting day 2 of menstrual cycle for 5 days Other Names: Clomid
Placebo Comparator: Placebo Will receive placebo plus clomiphene citrate.	Drug: 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. Drug: Clomiphene Citrate 50 mg of clomiphene citrate will be given starting day 2 of menstrual cycle for 5 days Other Names: Clomid

Arm

Intervention/Treatment

Active Comparator: Metformin Group

Will receive metformin plus clomiphene citrate

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.

Other Names:

glucophage

Drug: Clomiphene Citrate

50 mg of clomiphene citrate will be given starting day 2 of menstrual cycle for 5 days

Other Names:

Clomid

Placebo Comparator: Placebo

Will receive placebo plus clomiphene citrate.

Drug: 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.

Drug: Clomiphene Citrate

50 mg of clomiphene citrate will be given starting day 2 of menstrual cycle for 5 days

Other Names:

Clomid

Outcome Measures

Primary Outcome Measures

Clinical pregnancy rate [one cycle for each woman (28 days in average)]
Diagnosis of pregnancy by transvaginal ulterasound

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elham Raafat Mohamed	Cairo		Egypt

Sponsors and Collaborators

Elham Raafat

Investigators

Study Director: Sarah S Moawad, Lecturer, Ain Shams Maternity Hospital
Study Director: Ahmed M Bahaa Eldin, Professor, Ain Shams Maternity Hospital
Study Director: Hisham M Fathy, Professor, Ain Shams Maternity Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elham Raafat, resident of obstetric and gynecology, Ain Shams University

ClinicalTrials.gov Identifier:

NCT03681197

Other Study ID Numbers:

1982

First Posted:

Sep 21, 2018

Last Update Posted:

Mar 21, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Elham Raafat, resident of obstetric and gynecology, Ain Shams University

metformin,unexplained infertility

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2019