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Trial record 1 of 442 for:    Recruiting, Not yet recruiting Studies | Infertility
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Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility

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ClinicalTrials.gov Identifier: NCT03681197
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Elham Raafat, Ain Shams University

Tracking Information
First Submitted Date  ICMJE August 13, 2018
First Posted Date  ICMJE September 21, 2018
Last Update Posted Date March 21, 2019
Actual Study Start Date  ICMJE June 15, 2018
Estimated Primary Completion Date April 2019   (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
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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  ICMJE May 2019
Estimated Primary Completion Date April 2019   (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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE
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 March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP