MWH prophylaxis to reduce recurrent failures of implant after IVF or ICSI procedures.
- Conditions
- Inability to conceive after a year of sexual relations free from any system of contraceptionTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]MedDRA version: 14.1Level: PTClassification code 10005160Term: Blighted ovumSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
- Registration Number
- EUCTR2011-002219-28-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI PADOVA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
• age >18 • presence of one of the following risk factors: thrombophilia (Factor V Leiden, PG20210A mutation, MTHFR C677T gene mutation), 2 or more previous implantation failures •Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Exclusion criteria; • age < 18; • deficiency of antitrombin, protein C, protein S, antiphospholipid antibodies, previous VTE • no informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate whether prophylactic anticoagulation could improve the implantation rate in women subjected to PMA treatment.;Secondary Objective: Not declared.;Primary end point(s): Failure rate of the first implantation.;Timepoint(s) of evaluation of this end point: 28 days.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not declared.;Timepoint(s) of evaluation of this end point: Not declared