NCT02991950

Brief Summary

Prospective randomized study of patients with infertility candidates to Assisted ReproductiveTechniques (ART), screened for all inclusion and exclusion criteria, submitted to ART cycle with or without low molecular weight heparin (LMWH) administration. Aims of the study are to evaluate, primarily, pregnancy rate/embryo transfer, secondarily take home babies/embryo transfer, implantation rate, and the role of thrombophilic factors

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
271

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2011

Typical duration for phase_3

Status
terminated

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

July 1, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

3.7 years

First QC Date

November 29, 2016

Last Update Submit

December 13, 2016

Conditions

InfertilityLow Molecular Weight Heparin

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate/embryo transfer

    the investigators measured the pregnancy rate/embryo transfer using betaHcg dosage 12 days after embryo transfer

    12-14 days

Secondary Outcomes (3)

  • take home babies/embryo transfer

    38-40 weeks after embryo transfer

  • implantation rate

    3 weeks

  • role of thrombophilia in interfering with pregnancy rate/take home baby/implantation rate

    12-14 days and 38-40 weeks and 3 weeks

Study Arms (2)

parnaparin sodium

EXPERIMENTAL

Women in LMWH arm are administered with routine ovulation induction protocol and prophylactic dose of parnaparin sodium (LMWH), starting the day before the beginning of stimulation phase of the cycle until the result of the procedure is confirmed in terms of pregnancy yes or no and in case of pregnancy until the delivery or the end of pregnancy. Women in the LMWH arm will be tested for blood cell count twice in the first 10 days of therapy. Parnaparin will be administered at the dose of 100 IU/kg/day from the day before the beginning of stimulation phase of the cycle until the result of the procedure is confirmed in terms of pregnancy yes or no and in case of pregnancy until delivery or the end of the pregnancy. Used dosages Parnaparin 0.4 4250 UI Parnaparin 0.6 6400 UI

Drug: Parnaparin Sodium

no treatment

NO INTERVENTION

Women in the control arm are administered with routine ovulation induction protocol, without the addition of parnaparin sodium.

Interventions

Parnaparin SodiumDRUG

Parnaparin sodium ( Fluxum 4250 anti-Xa IU /0.4 mL or Fluxum 6400 anti-Xa IU /0.6mL; Alfa Wassermann S.p.A.) was administered at a dose of 100 IU/kg/day from the day before the beginning of the stimulation phase of the cycle until the result of the procedure was confirmed by pregnancy and, in the case of evolutive pregnancy, until delivery or the end of pregnancy

Also known as: Fluxum
parnaparin sodium

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women ≥18 years and ≤40 years, candidated to a fresh IVF/ICSI cycle with routine ovulation induction protocol

You may not qualify if:

  • v-vCouples candidated to a frozen IVF/ICSI cycle with routine ovulation induction protocol
  • Testicular or frozen sperm (TESE procedure not allowed)
  • Presence of hormonal disorders not compensated with specific therapy or history of immunological disease (autoimmune thyroiditis, connectivitis, RA, SLE, etc )
  • Presence of antiphospholipides autoantibodies or other severe thrombophilia (AT, PS, PC deficiency or homozygous FV Leiden or FIIG20210A, or double eterozygous FV Leiden and FIIG20210A)
  • Presence of abnormal platelets count and congenital or acquired coagulopathy ASA or steroid therapy administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Interventions

parnaparinFluxum

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • corrado lodigiani, MD,PHD

    Thrombosis Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 14, 2016

Study Start

July 1, 2011

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

December 14, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share