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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 : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Elham Raafat, Ain Shams University

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 Type : Interventional  (Clinical Trial)
Estimated 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 : June 15, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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 Name: glucophage

Drug: Clomiphene Citrate
50 mg of clomiphene citrate will be given starting day 2 of menstrual cycle for 5 days
Other Name: 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 Name: Clomid




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: one cycle for each woman (28 days in average) ]
    Diagnosis of pregnancy by transvaginal ulterasound



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681197


Contacts
Contact: Elham R Mohamed 0021156230921 Elhamraafat@outlook.com

Locations
Egypt
Elham Raafat Mohamed Recruiting
Cairo, Egypt
Contact: Elham R Mohamed    0021156230921    Elhamraafat@outlook.com   
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

Responsible Party: Elham Raafat, resident of obstetric and gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03681197     History of Changes
Other Study ID Numbers: 1982
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Elham Raafat, Ain Shams University:
metformin,unexplained infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Metformin
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Hypoglycemic Agents
Physiological Effects of Drugs
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators