Birth RateNCT02407730
EFFects of Thrombophilia on the Outcomes of Assisted Reproduction Technologies
An observational study of Birth Rate and Embryo Implantation, run by G. d'Annunzio University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Birth Rate, Embryo Implantation, Reproductive Techniques
- How many people
- 687 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women 18 years or older undergoing ART
Who may be able to join
- women undergoing ART
- age 18 years or older
Who cannot join
- ongoing anticoagulant therapy
- previous venous thromboembolism
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFects of Thrombophilia on the Outcomes of Assisted Reproduction
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
- Medical subject headings
- Thrombophilia
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Measured: Participants will be followed for the duration of the pregnancy, an expected average of 9 months
Secondary outcomes (1)
implantation rate
Measured: Participants will be followed from the implantation to the ultrasonography to document the gestational sac, an expected average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 687 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcello Di Nisio, G. d'Annunzio University
- Investigators
- Marcello Di Nisio, Principal investigator, University G. D'Annunzio, Chieti, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407730
- Sponsor's protocol ID
- EFFORT
- Status last verified
- Aug 2019
- First submitted
- 20 Mar 2015
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFects of Thrombophilia on the Outcomes of Assisted Reproduction
- ClinicalTrials.gov ID
- NCT02407730
- Acronym / sponsor ID
- EFFORT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 687 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women 18 years or older undergoing ART
Key inclusion criteria (2 listed)
- women undergoing ART
- age 18 years or older
Key exclusion criteria (3 listed)
- ongoing anticoagulant therapy
- previous venous thromboembolism
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Live birth rate
Time frame: Participants will be followed for the duration of the pregnancy, an expected average of 9 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcello Di Nisio principal investigator
University G. D'Annunzio, Chieti, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Rate and Embryo Implantation, run by G. d'Annunzio University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: Participants will be followed for the duration of the pregnancy, an expected average of 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.