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Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia (MetRPL)

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ClinicalTrials.gov Identifier: NCT01718340
Recruitment Status : Unknown
Verified May 2014 by alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt.
Recruitment status was:  Recruiting
First Posted : October 31, 2012
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt

Tracking Information
First Submitted Date  ICMJE August 18, 2012
First Posted Date  ICMJE October 31, 2012
Last Update Posted Date May 28, 2014
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
The primary outcome is to evaluate the clinical pregnancy rate and the effectiveness of Metformin in the reduction of EPL in women with PCOS [ Time Frame: 2 ys ]
The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy,
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01718340 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study and any fetal malformation [ Time Frame: 2 ys ]
The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy, the other group will stop the drug once pregnancy test become positive. Pregnancy follow up including the early and second trimester pregnancy loss, Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia
Official Title  ICMJE Phase 4 Study of Effectiveness of Metformin in Patients With Unexplained Recurrent Miscarriages
Brief Summary

The prevalence of insulin resistance is increased in women with recurrent miscarriage compared with matched fertile controls,Insulin resistance (IR) in this syndrome is not only implicated toward early pregnancy loss (EPL) but also pathognomic for various obstetrical complications during pregnancy.An elevated free androgen index appears to be a prognostic factor for a subsequent miscarriage in women with recurrent miscarriage.

There is insufficient evidence to evaluate the effect of metformin supplementation in pregnancy to prevent a miscarriage in women with recurrent miscarriage.

Detailed Description The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy, the other group will stop the drug once pregnancy test become positive. Pregnancy follow up including the early and second trimester pregnancy loss, Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study.
Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Abortion, Habitual
Intervention  ICMJE Drug: Metformin
metformin tablet 500mg three time per day
Other Names:
  • glucophage
  • cidophage
  • amophage
Study Arms Experimental: Metformin
The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy, the other group will stop the drug once pregnancy test become positive
Intervention: Drug: Metformin
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 30, 2012)
396
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date June 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • women who are diagnosed to have PCOS and/or haven hyper insulinaemia and have a previous history of recurrent miscarriages.

Exclusion Criteria:

  • Any patients with PCOS or hyper insulinaemia previously treated by any forms of insulin sensitizers.

Age above forty years old .

  • Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
  • Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
  • Fibroids distorting uterine cavity .
  • Abnormal parental karyotype .
  • Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01718340
Other Study ID Numbers  ICMJE MetRPL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt
Study Sponsor  ICMJE Woman's Health University Hospital, Egypt
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alaa M Ismail, M D Faculty of medicine,Assiut university,Egypt
PRS Account Woman's Health University Hospital, Egypt
Verification Date May 2014

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