The Role of Prothrombin Gene and Methylenetetrahydrofolate Reductase(MTHFR) Gene Polymorphisms as Risk Factors for Recurrent Miscarriage

NCT03209063 | Unknown

• 1 other identifier: TROPGP
• Study Type: observational
• Target: 285
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recurrent miscarriage is a pregnancy loss before 20 weeks of gestation. The recurrent pregnancy loss(RPL) usually occurring in the first trimester of gestation and its rate is quite high (15-20% even in full reproductive period) . In 2012, the American Society for Reproductive Medicine Practice Committee issued a statement that defined recurrent pregnancy loss as a disease distinct from infertility defined by two or more failed consecutive pregnancies.approximately 40% of couples will have an etiology identified that could be associated with their loss.

Conditions

Recurrent Miscarriage

Outcome Measures

Primary Outcomes (1)

• The study will compare the percentage of prothrombin gene and MTHFR gene polymorphisms in cases with recurrent miscarriage and healthy control group.

  using polymerase chain reaction Polymerase chain reaction

  2 days

Study Arms (2)

Group I

195 Patients having history of two or more miscarriages.

Diagnostic Test: polymerase chain reaction

Group II

90 healthy controls less than 35 years with no history of miscarriage and at least one uncomplicated full-term pregnancy

Diagnostic Test: polymerase chain reaction

Interventions

polymerase chain reaction DIAGNOSTIC_TEST

diagnostic test as Polymerase chain reaction for detection of Prothrombin gene and methylenetetrahydrofolate reductase gene polymorphisms

Also known as: homocysteine assay

Group I; Group II

Eligibility Criteria

• Age: 17 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted at Clinical Pathology Department,Women's Health Hospital ,Assiut University Hospital, Faculty of Medicine, Assiut University

You may qualify if:

• Age less than 35 years.
• History of two or more spontaneous miscarriages

You may not qualify if:

• Age more than 35 years.
• Women with elevated level of TSH above (2.5 mIU/ml) and uncontrolled DM.
• Women with autoimmune disorder (antiphospholipid antibody syndrome)with LA1/LA2 ratio more than( 1.2).
• Women receiving oral contraceptive pills and anticoagulant drugs.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Farahmand K, Totonchi M, Hashemi M, Reyhani Sabet F, Kalantari H, Gourabi H, Mohseni Meybodi A. Thrombophilic genes alterations as risk factor for recurrent pregnancy loss. J Matern Fetal Neonatal Med. 2016;29(8):1269-73. doi: 10.3109/14767058.2015.1044431. Epub 2015 Jul 2.

  PMID: 26135458 BACKGROUND

• Ahmed Abd Elhameed Z, Shaaban OM, Abd Elazeem HG, Abouelfadle A, Farghaly T, Mahran G, Seddik MI. Role of Prothrombin and Methylenetetrahydrofolate Reductase Gene Polymorphisms as well as Thrombophilia Markers, as Risk Factors for Unexplained Recurrent Miscarriage: A Case-Control Study. Int J Fertil Steril. 2025 Jan 5;19(1):36-43. doi: 10.22074/ijfs.2023.1986225.1418.

  PMID: 39827389 DERIVED

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ghada M Mahran, MD

  Assiut University, Faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanan G Abdelazim, prof.doctor

CONTACT

01227370520; hanangalal2000@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 1, 2017
• First Posted: July 6, 2017
• Study Start: July 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 30, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share