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Completed

NCT Number: NCT02407730

EFFects of Thrombophilia on the Outcomes of Assisted Reproduction Technologies

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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Key information

Conditions

Birth Rate Embryo Implantation Hematologic Diseases Hemic and Lymphatic Diseases Reproductive Techniques Thrombophilia

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Universita degli Studi G. d'Annunzio Chieti e Pescara

Chieti, 66100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women undergoing ART
  • age 18 years or older

Exclusion criteria

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

EFFects of Thrombophilia on the Outcomes of Assisted Reproduction

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 3, 2015
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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