NCT02610608

Brief Summary

This study aims at evaluating clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation. Secondary outcomes are : 1) to describe the incidence and risk factors of arterial and venous thrombosis in women undergoing assisted reproductive technology and 2)to identify the incidence and risk factors for ovarian hyperstimulation syndrome in these women

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

9 active sites

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

First Submitted

Initial submission to the registry

November 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 2, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2016

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

November 18, 2015

Last Update Submit

July 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of professional clinical practice for ovarian stimulation care

    Until 12 months followin ovarian stimulation

Secondary Outcomes (2)

  • Arterial and/or venous thrombosis

    until 12 months following ovarian stimulation

  • Risk factors for thrombosis

    until 12 months following ovarian stimulation

Other Outcomes (1)

  • Incidence and risk factors for ovarian hyperstimuation syndrome

    until 12 months following ovarian stimulation

Study Arms (1)

Women undergoing ART

Observation of the incidence of venous and arterial thrombosis following ovarian stimulation

Other: ovarian stimulation

Interventions

evaluation of clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation

Women undergoing ART

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing assisted reproductive thechnology

You may qualify if:

  • All women undergoing ovarian stimulation in order to receive in vitro fertilization

You may not qualify if:

  • Age\<18 years
  • Women refusing to particpate in the study
  • No health coverage
  • Women under guardianship
  • Women receiving therapeutic doses of anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Clinique Pasteur

Brest, 29200, France

Location

Medicentre- Clinique du Val d'Ouest

Écully, 69130, France

Location

SELARL Gynecologia

Grenoble, 38000, France

Location

Hôpital Saint Joseph

Marseille, 13001, France

Location

CHU de Nice - Hôpital de l'Archet

Nice, 06202, France

Location

AP-HP - Hôpital Bichat

Paris, 75018, France

Location

Clinique Multualiste La sagesse

Rennes, 35000, France

Location

Clinique Mathilde

Rouen, 76100, France

Location

CHU de Strasbourg - CMCO

Schiltigheine, 67300, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

One blood sample for each women particpating in the study

MeSH Terms

Conditions

Ovarian Hyperstimulation SyndromeCardiovascular DiseasesEmbolism and Thrombosis

Interventions

Ovulation Induction

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 20, 2015

Study Start

February 2, 2016

Primary Completion

November 20, 2016

Study Completion

November 20, 2016

Last Updated

July 10, 2020

Record last verified: 2020-07

Locations