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CompletedNCT02407730Updated Aug 8, 2019

EFFects of Thrombophilia on the Outcomes of Assisted Reproduction Technologies

An observational study in Birth Rate, Embryo Implantation and Reproductive Techniques, sponsored by G. d'Annunzio University. Completed at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-08.

Sponsored by G. d'Annunzio University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
687
Ages
18 Years and older
Sex
Female
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Study summary

Both hereditary and acquired thrombophilia have been associated with recurrent miscarriage and pregnancy complications. Thrombophilia could favor the development of thrombosis of the maternal vasculature and obstacle placentation. Some studies have suggested a role of thrombophilia in the failure of assisted reproductive techniques although this association has been recently questioned. The scope of this study is to evaluate the effect of thrombophilia on the implantation rate and live birth rate in women undergoing ART.

Design: prospective, observational study Primary end-point: live birth rate. Secondary end-points: implantation rate, venous thromboembolic events during ART up to 6 weeks post-partum

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Conditions studied

  • Birth Rate
  • Embryo Implantation
  • Reproductive Techniques
  • Thrombophilia

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In context

Thrombophilia

75 studies on the registry are indexed under Thrombophilia; 16 are open to participants now.

This study's enrollment of 687 is above the median of 106 across 50 observational studies indexed under Thrombophilia.

Browse Thrombophilia studies →

Lead sponsor

G. d'Annunzio University is the lead sponsor of 62 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All women 18 years or older undergoing ART

Inclusion criteria

  • women undergoing ART
  • age 18 years or older

Exclusion criteria

Exclusion Criteria:

  • ongoing anticoagulant therapy
  • previous venous thromboembolism
  • no informed consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
687 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Live birth rate

    Time frame: Participants will be followed for the duration of the pregnancy, an expected average of 9 months

Secondary outcomes

  1. implantation rate

    Time frame: Participants will be followed from the implantation to the ultrasonography to document the gestational sac, an expected average of 7 weeks

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Study locations

1 site
  • Universita degli Studi G. d'Annunzio Chieti e Pescara
    Chieti, 66100, Italy
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02407730
Lead sponsor
G. d'Annunzio University
Responsible party
Marcello Di Nisio (Principal Investigator, G. d'Annunzio University) — Principal investigator
First posted
Apr 3, 2015
Start date
Jan 2015
Primary completion
Jul 2017
Completion
May 2018
Last update
Aug 8, 2019

Study contacts

Marcello Di Nisio
principal investigator · University G. D'Annunzio, Chieti, Italy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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