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LMWH prophylaxis to reduce recurrent failures of implant after IVF or ICSI procedures.

Effect of pharmacological prophylaxis with low molecular weight heparin on implantation in women undergoing assisted reproductive procedures to prevent implant failure: a prospective randomized study.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-002219-28-IT
Enrollment
Unknown
Registered
2012-03-02
Start date
2011-12-12
Completion date
Unknown
Last updated
2012-12-17

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

Conditions

Inability to conceive after a year of sexual relations free from any system of contraception MedDRA version: 14.1 Level: PT Classification code 10005160 Term: Blighted ovum System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Trade Name: FRAGMIN*SC 6SIR 5000UI 0,2ML Pharmaceutical Form: Injection INN or Proposed INN: DALTEPARIN SODIUM CAS Number: 9041-08-1 Current Sponsor code: NA Other descriptive name: NA Concentration u

Sponsors

AZIENDA OSPEDALIERA DI PADOVA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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: Exclusion criteria; • age < 18; • deficiency of antitrombin, protein C, protein S, antiphospholipid antibodies, previous VTE • no informed consent.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary end point(s): Not declared.;Timepoint(s) of evaluation of this end point: Not declared—

Countries

Italy

Contacts

Public ContactClin Ostet Ginecol e Clin Medica 4

AZIENDA OSPEDALIERA DI PADOVA

michele.gangemi@unipd.it049/8211842

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026