Low Molecular Weight Heparin to Improve Pregnancy Outcome in Patients With Recurrent Implantation Failure

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2023
• Main ID: NCT02607319
• Date of registration: 11/11/2015
• Prospective Registration: No
• Primary sponsor: American University of Beirut Medical Center
• Public title: Low Molecular Weight Heparin to Improve Pregnancy Outcome in Patients With Recurrent Implantation Failure BRIF
• Scientific title: Effect of Low Molecular Weight Heparin (Bemiparin) on Implantation Rate in Patients With Recurrent Implantation Failure Undergoing IVF/ICSI - A Prospective Randomized Clinical Trial
• Date of first enrolment: November 2015
• Target sample size: 165
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02607319
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Lebanon

Contacts

• Name: Johnny Awwad, MD
• Affiliation: AUBMC

Key inclusion & exclusion criteria

Inclusion Criteria:

- History of three or more consecutively failed In Vitro Fertilization (IVF) cycles
after embryo transfer.

- Normal uterine cavity (as assessed by hysteroscopy or HSG).

- Normal hormonal investigation: TSH, PRL, FBS.

- Normal acquired/inherited thrombophilia profile: LAC, ACA IgG/IgM, Prot S,
Antithrombin III, beta-2 glycoprotein, Factors V, II, MTHFR.

- Normal semen analysis and mild/moderate male factor (Total motile sperm count > 5
million/ml and/or normal WHO morphology >20%.

- Patient provides written informed consent.

Exclusion Criteria:

- Evidence of low ovarian reserve by at least one of the following: AMH = 1,5 ng/mL
and/or basal CD 3 FSH = 10 mIU/mL and/or basal CD 3 Estradiol = 60 ng/mL and/or
previous egg collection yield = 3 oocytes.

- Preexisting medical condition (thyroid disease, diabetes mellitus, hypertension,
pulmonary conditions, cardiac condition…).

- Severe male factor infertility (Total motile sperm count < 5 million/ml and/or normal
WHO morphology <20%).

- Hypersensitivity to Heparin or its derivatives.

- Acquired thrombophilia.

- Active hemorrhage or increased risk of bleeding due to impairment of homeostasis.

- Severe impairment of liver or pancreatic function.

- Severe renal insufficiency (Creatinine Clearance < 30 ml/min).

- Injuries to or operations on the central nervous system, eyes and ears within the last
2 months.

- Disseminated Intravascular Coagulation (DIC) attributable to heparin-induced
thrombocytopenia.

- Acute bacterial endocarditis and endocarditis lenta.

- Any organic lesion with high risk of bleeding (e.g.: active peptic ulcer, hemorrhagic
stroke, cerebral aneurysm or cerebral neoplasms).



Age minimum: 18 Years
Age maximum: 38 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Sterility

Intervention(s)

Drug: Bemiparin sodium

Primary Outcome(s)

Implantation rate (%) [Time Frame: Vaginal ultrasound at 8 weeks gestation]

Secondary Outcome(s)

Live birth rate (%) [Time Frame: Time of delivery up to 42 weeks gestation]

Ongoing pregnancy rate (%) [Time Frame: Vaginal ultrasound at 20 weeks of gestation]

Clinical pregnancy rate (%) [Time Frame: Vaginal ultrasound at 8 weeks gestation]

Total pregnancy rate (%) [Time Frame: Up to 15 days from oocyte collection]

Secondary ID(s)

AmericanUBMCRIF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors