C677T Methylenetetrahydrofolate Reductase Mutation

NCT05864937 | Completed

• 1 other identifier: PI2017_843_0045
• Study Type: observational
• Target: 363
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Mutation

Keywords

recurrent miscarriages; aspirin; folic acid

Outcome Measures

Primary Outcomes (1)

• number of miscarriages

  The 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

  2years

Interventions

infertily evaluation OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with three or more consecutive first-trimester miscarriages who were carrying the C677T MTHFR gene mutation and were treated and followed-up by the Department of Obstetrics, Gynaecology and Reproductive Medicine, Amiens University Medical Centre, Amiens, France between January 2006 and December 2011.

You may qualify if:

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

You may not qualify if:

• Patients with the A1298C polymorphism

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

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

Study Officials

• Moncef Ben Khlifa, MD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: May 18, 2023
• Study Start: December 1, 2011
• Primary Completion: September 28, 2016
• Study Completion: September 28, 2016
• Last Updated: May 18, 2023

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share