NCT05864937

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
• Phase: —
• Study type: Observational
• Enrollment: 363 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Mutation

Interventions

Type	Name	Description
OTHER	infertily 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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2016-09-28
• Completion: 2016-09-28
• First posted: 2023-05-18
• Last updated: 2023-05-18