NCT02607319

Brief Summary

The objective of this study is to determine the effect of Bemiparin, a low molecular weight heparin, on implantation rate in women with unexplained recurrent implantation failure undergoing IVF/ICSI treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

6.7 years

First QC Date

November 11, 2015

Last Update Submit

July 19, 2023

Conditions

Sterility

Keywords

Recurrent Implantation FailureImplantationlow molecular weight heparinIn vitro FertilizationAssisted Reproductive TechnologyPregnancy

Outcome Measures

Primary Outcomes (1)

  • Implantation rate (%)

    Number of intrauterine gestational sacs observed by transvaginal ultrasonography divided by the number of transferred embryos

    Vaginal ultrasound at 8 weeks gestation

Secondary Outcomes (4)

  • Live birth rate (%)

    Time of delivery up to 42 weeks gestation

  • Ongoing pregnancy rate (%)

    Vaginal ultrasound at 20 weeks of gestation

  • Clinical pregnancy rate (%)

    Vaginal ultrasound at 8 weeks gestation

  • Total pregnancy rate (%)

    Up to 15 days from oocyte collection

Study Arms (2)

Low molecular weight heparin

EXPERIMENTAL

Bemiparin sodium 3,500 IU anti Xa/0.2 ml solution (Hibor; Laboratories Rovi Pharmaceuticals) for injection in pre-filled syringes.

Drug: Bemiparin sodium

No intervention group

NO INTERVENTION

Control group receiving standard care.

Interventions

Bemiparin sodiumDRUG

Bemiparin sodium 3,500 IU will be started on the evening of the same day of embryo transfer and until the day of pregnancy test. If the test is positive, Bemiparin will be discontinued by the end of the 12th week of gestation.

Also known as: Hibor
Low molecular weight heparin

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Johnny Awwad, MD

    AUBMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 18, 2015

Study Start

November 1, 2015

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

LE(1)