Infertile patients with at least three failed assisted reproductive tecniques MedDRA version: 14.1 Level: SOC Classification code 10036585 Term: Pregnancy, puerperium and perinatal conditions System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Conditions
Interventions
Trade Name: FLUXUM*SC 6SIR 0,4ML 4250UIaxa
Pharmaceutical Form: Injection
INN or Proposed INN: PARNAPARIN SODIUM
CAS Number: 9041-08-1
Concentration unit: anti-Xa IU anti-Xa activity International Uni
Sponsors
ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Women, 36-40 years •At least 6 good quality embryos transferred in 3 or more previous IVF/ICSI cycles without signs of implantation. •A normal response with at least 6 oocytes retrieved with standard induction protocol. •Total progressive motile count of at least 1.000.000 sperms/eiaculate. •No testicular or frozen sperms. •Normal uterine cavity as shown by SIS or ISC. •FSH =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Age 40 years •Less than 3 previous IVF/ICSI cycles without signs of implantation •Total progressive motile count < than 1.000.000 sperms/eiaculate. • Testicular or frozen sperms. • Previous surgery for miomas and / or endometriosis. • Clinical or ultrasound diagnosis of endometriosis. • Patients treated in previous cycles with LMWH. • Hormonal, or immunological disorders detected • FSH < 10 mUI/ml or autoantibody positivity. • APA positivity or other severe thrombophilia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to evaluate the pregnancy rate in patients with repeated implantation failures undergoing a new ART cycle with or without LMWH administration.;Secondary Objective: To evaluate the thrombophilic factor’s role in the clinical pregnancy rate in patients with at least three repeated implantation failures undergoing assisted reproductive techniques (ART) treated with or without weight adjusted LMWH;Primary end point(s): The aim of the study is to evaluate the pregnancy rate in patients with repeated implantation failures undergoing a new ART cycle with or without LMWH administration.;Timepoint(s) of evaluation of this end point: 20 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the thrombophilic factor’s role in the clinical pregnancy rate in patients with at least three repeated implantation failures undergoing assisted reproductive techniques (ART) treated with or without weight adjusted LMWH;Timepoint(s) of evaluation of this end point: 20 weeks | — |
Countries
Italy
Contacts
Public ContactCentro Trombosi
Istituto Clinico Humanitas
Outcome results
None listed