Efficacy of low molecular weight heparin in improving fertility in women with previous failures in fertility procedures

• Conditions: Infertile patients with at least three failed assisted reproductive tecniques; MedDRA version: 14.1Level: SOCClassification code 10036585Term: Pregnancy, puerperium and perinatal conditionsSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2011-003080-30-IT
• Lead Sponsor: ISTITUTO CLINICO HUMANITAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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 < 10 mUI/ml. •AMH = 1.0 ng./ml. •No hormonal, or immunological disorders detected •No APA or other severe thrombophilia detected •Normal female and male peripheral karyotype
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 240
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Age <36 years or >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified