The Role of Prothrombin Gene and Methylenetetrahydrofolate Reductase(MTHFR) Gene Polymorphisms as Risk Factors for Recurrent Miscarriage
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ClinicalTrials.gov Identifier: NCT03209063 |
Recruitment Status :
Not yet recruiting
First Posted : July 6, 2017
Last Update Posted : December 19, 2019
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Condition or disease | Intervention/treatment |
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Recurrent Miscarriage | Diagnostic Test: polymerase chain reaction |
Study Type : | Observational |
Estimated Enrollment : | 180 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | The Role of Prothrombin Gene and Methylenetetrahydrofolate Reductase(MTHFR) Gene Polymorphisms as Risk Factors for Recurrent Miscarriage |
Estimated Study Start Date : | December 20, 2019 |
Estimated Primary Completion Date : | August 1, 2020 |
Estimated Study Completion Date : | December 30, 2020 |

Group/Cohort | Intervention/treatment |
---|---|
Group 1
90 healthy controls less than 35 years with no history of miscarriage and at least one uncomplicated full-term pregnancy.
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Diagnostic Test: polymerase chain reaction
diagnostic test as Polymerase chain reaction for detection of Prothrombin gene and methylenetetrahydrofolate reductase gene polymorphisms
Other Name: homocysteine assay |
Group 2
90 Patients having history of two or more miscarriages.
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Diagnostic Test: polymerase chain reaction
diagnostic test as Polymerase chain reaction for detection of Prothrombin gene and methylenetetrahydrofolate reductase gene polymorphisms
Other Name: homocysteine assay |
- The study will compare the percentage of prothrombin gene and MTHFR gene polymorphisms in cases with recurrent miscarriage and healthy control group. [ Time Frame: 2 days ]using polymerase chain reaction Polymerase chain reaction

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria
- Age less than 35 years.
- History of two or more spontaneous miscarriages
Exclusion Criteria:
- Age more than 35 years.
- . Women with elevated level of TSH above (2.5 mIU/ml) or prolactin above( 19.5 ng/mL)and uncontrolled DM.
- Women with autoimmune disorder (antiphospholipid antibody syndrome)with LA1/LA2 ratio more than( 1.2).
- Women receiving oral contraceptive pills.

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): NCT03209063
Contact: Hanan G Abdelazim, prof.doctor | 01227370520 | hanangalal2000@yahoo.com |
Principal Investigator: | Ghada M Mahran, MD | Assiut University, Faculty of medicine |
Responsible Party: | Ghada Mahran, principal investigator, Assiut University |
ClinicalTrials.gov Identifier: | NCT03209063 |
Other Study ID Numbers: |
TROPGP |
First Posted: | July 6, 2017 Key Record Dates |
Last Update Posted: | December 19, 2019 |
Last Verified: | December 2019 |
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 |
Abortion, Spontaneous Abortion, Habitual Pregnancy Complications |