NCT04359576

Brief Summary

The study focus on the impact of estrogen/progesterone substitution during artificial cycle frozen embryo transfer (AC-FET) in women undertaking assisted reproductive technology treatment (ART).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

2.6 years

First QC Date

April 21, 2020

Last Update Submit

April 18, 2021

Conditions

Frozen Embryo Transfer

Outcome Measures

Primary Outcomes (1)

  • coagulation

    Primary and secondary hemostasis parameters

    1 year

Study Arms (1)

FET

Estrogen/progesterone substituted and natural cycles

Diagnostic Test: Primary and secondary hemostasis

Interventions

Primary and secondary hemostasisDIAGNOSTIC_TEST

Focus on platelet aggregation, primary and secondary hemostasis parameters

FET

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy women receiving FET

You may qualify if:

  • Women receiving FET with or without estrogen/progesterone substitution

You may not qualify if:

  • Known bleeding disorder
  • Indication for thromboprophylaxis during ART treatment
  • Treatment with anti-platelet medication including non-steroid-anti-inflammatory drugs (NSAIDs) within the last week
  • Donor recipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Horsens Regional Hospital

Horsens, 8700, Denmark

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

August 1, 2019

Primary Completion

March 1, 2022

Study Completion

December 1, 2024

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)