MutationC677TNCT05864937
C677T Methylenetetrahydrofolate Reductase Mutation
An observational study of Mutation, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mutation
- What is being tested?
- infertily evaluation
- How many people
- 363 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2011to 28 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- patients with three or more consecutive first-trimester miscarriage
- Three or more consecutive first-trimester miscatrriages
- C677T MTHFR gene mutation
Who cannot join
- Patients with the A1298C polymorphism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Preventive Treatments for Patients With Recurrent Miscarriages Carrying a C677T Methylenetetrahydrofolate Reductase Mutation: 5-year Experience
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).
Read the 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
- Being tested
- infertily evaluation
- Keywords
- recurrent miscarriages, aspirin, folic acid
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infertily evaluationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Dec 2011
- Primary completion28 Sep 2016
- Study completion28 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moncef Ben Khalifa, PU-PH, Principal investigator, CHU Amiens-Picardie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864937
- Sponsor's protocol ID
- PI2017_843_0045
- Acronym
- C677T
- Status last verified
- Jun 2026
- First submitted
- 23 Aug 2018
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Preventive Treatments for Patients With Recurrent Miscarriages Carrying a C677T Methylenetetrahydrofolate Reductase Mutation: 5-year Experience
- ClinicalTrials.gov ID
- NCT05864937
- Acronym / sponsor ID
- C677T / PI2017_843_0045
- Conditions
- Mutation
- Keywords
- recurrent miscarriages, aspirin, folic acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- patients with three or more consecutive first-trimester miscarriage
- Three or more consecutive first-trimester miscatrriages
- C677T MTHFR gene mutation
Key exclusion criteria (1 listed)
- Patients with the A1298C polymorphism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infertily evaluationAll 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. | Other | – |
Primary outcome
number of miscarriages
Time frame: 2years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moncef Ben Khalifa, PU-PH principal investigator
CHU Amiens-Picardie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mutation, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of miscarriages (time frame: 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.