Effect of LMWH on Pregnancy Outcome in Women With Multiple Failures of IVF-ET

• Status: Recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: Female

Summary

Low-Molecular-Weight-Heparin (LMWH) has been used empirically in patients undergoing in-vitro fertilization embryo transfer (IVF-ET) with the purpose to aid in improving pregnancy outcomes. The potential mechanism is that LMWH could exert its anticoagulant effect by inhibiting factor Xa, reducing the risk of insufficiency blood supply in the very early stage of pregnancy. Moreover, LMWH is supposed to play a role in manipulating blastocyst supposition, adhesion, and implantation, as well as trophoblast differentiation and invasion. However, limited high-quality clinical trials focus on the effectivity of LMWH in IVF-ET, and the published evidence is not consensus, leading to considerable controversy in the clinical application of LMWH in IVF-ET patients. Here, investigators try to evaluate the effect of LMWH on pregnancy outcome in women with multiple failures of IVF-ET via a multi-center randomized controlled trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen Zhongshan Urology Hospital
• Collaborators: Renmin Hospital of Wuhan University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Treatments: Calcium heparin; Dalteparin; Enoxaparin; Enoxaparin sodium; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

Inclusion Criteria:

• ≥2 consecutive IVF/ICSI-ET without clinical pregnancy

• ≥2 oocytes retrieval cycles

• 19- Normal ovarian reserve ( AMH> 1, FSH <10 )

• Willing and able to sign the informed consent.

Exclusion Criteria:

• Uterine abnormalities confirmed by hysterosalpingography or hysteroscopy

• Parental chromosomal abnormalities

• PCOS

• Anti-phospholipid Syndrome

• Endocrine disorder

• Endometriosis

• Hydrosalpinx

• Chronic disease (liver, renal, thyroid, and thrombocytopenia)

• Regular anticoagulation or antiplatelet treatment

• Patients who had contraindication for unfractionated heparin therapy

• History of tuberculosis, HIV, HBV, HCV or tests indicating carriage of HBV or HCV, or positive interferon-gamma release assay in any of the couple

• Enrollment in another clinical trial