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C677T Methylenetetrahydrofolate Reductase Mutation

Comparison of Two Preventive Treatments for Patients With Recurrent Miscarriages Carrying a C677T Methylenetetrahydrofolate Reductase Mutation: 5-year Experience

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05864937
Acronym
C677T
Enrollment
363
Registered
2023-05-18
Start date
2011-12-01
Completion date
2016-09-28
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mutation

Keywords

recurrent miscarriages, aspirin, folic acid

Brief summary

To investigate the effect of anticoagulant treatment on pregnancy outcomes in patients with previous recurrent miscarriages (RM) who carry a methylenetetrahydrofolate reductase (MTHFR) gene mutation. In this longitudinal retrospective study, patients with RM were treated during pregnancy with either: (i) 100 mg/day aspirin and 5 mg/day folic acid (group 1); or the same protocol plus 0.4 mg/day enoxaparin (group 2). An age-matched group of triparous women without RM or thrombophilia was used as the control group (group 3).

Detailed description

Recurrent miscarriage (RM) is defined as three or more consecutive spontaneous fetal losses and it affects 0.3% to 1% of pregnancies.To investigate the effect of anticoagulant treatment on pregnancy outcomes in patients with previous recurrent miscarriages (RM) who carry a methylenetetrahydrofolate reductase (MTHFR) gene mutation. In this longitudinal retrospective study, patients with RM were treated during pregnancy with either: (i) 100 mg/day aspirin and 5 mg/day folic acid (group 1); or the same protocol plus 0.4 mg/day enoxaparin (group 2). An age-matched group of triparous women without RM or thrombophilia was used as the control group (group 3).

Interventions

OTHERinfertily evaluation

All couples had undergone a standard infertility evaluation, which included medical history, physical examination, and assessment of tubal patency by either hysterosalpingography or laparoscopy and hormonal analysis on cycle day 3. A transvaginal ultrasound scan was performed on the second day of the cycle. On the same day, ovarian stimulation was carried out with recombinant FSH follitropin);rFSH;Gonal-F,MerckSerono,France,orfollitropin ; Puregon, MSD, France), urinary FSH (urofollitropin, Fostimon, France),orhMG(menotropin,Menopur,France)atastarting dose of 75 IU/day from the second day of the cycle.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* patients with three or more consecutive first-trimester miscarriage * Three or more consecutive first-trimester miscatrriages * C677T MTHFR gene mutation

Exclusion criteria

* Patients with the A1298C polymorphism

Design outcomes

Primary

MeasureTime frameDescription
number of miscarriages2yearsThe objective of this study was to evaluate the effect of three components: aspirin, alpha blockers and folic acid in women with miscarriages consecutive first-trimester mutation of the MTHFR C677T gene versus the effet of a combination of aspirin and folic acid in patients with three or more consecutive first-trimester miscarriages who were carrying the C677T MTHFR gene mutation

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMoncef Ben Khalifa, PU-PH

CHU Amiens-Picardie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026