Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility

Tracking Information
First Submitted Date ICMJE	August 13, 2018
First Posted Date ICMJE	September 21, 2018
Last Update Posted Date	September 21, 2018
Actual Study Start Date ICMJE	June 15, 2018
Estimated Primary Completion Date	November 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 20, 2018)	Clinical pregnancy rate [ Time Frame: one cycle for each woman (28 days in average) ]; Diagnosis of pregnancy by transvaginal ulterasound
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility
Official Title ICMJE	Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility
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 .
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 Type ICMJE	Interventional
Study Phase	Early Phase 1
Study Design ICMJE	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
Condition ICMJE	Infertility
Intervention ICMJE	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 Name: glucophage; 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 Name: Clomid
Study Arms	Active Comparator: Metformin Group Will receive metformin plus clomiphene citrate Interventions: Drug: Metformin Drug: Clomiphene Citrate; Placebo Comparator: Placebo Will receive placebo plus clomiphene citrate. Interventions: Drug: Placebo Drug: Clomiphene Citrate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: September 20, 2018)	170
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2018
Estimated Primary Completion Date	November 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: Female
Ages	20 Years to 35 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact: Elham R Mohamed 0021156230921 Elhamraafat@outlook.com
Listed Location Countries ICMJE	Egypt
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT03681197
Other Study ID Numbers ICMJE	1982
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	Elham Raafat, Ain Shams University
Study Sponsor ICMJE	Elham Raafat
Collaborators ICMJE	Not Provided
Investigators ICMJE	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
PRS Account	Ain Shams University
Verification Date	September 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP