NCT03470610

Brief Summary

Observational study of reproductive outcome after frozen embryo transfer in HRT with vaginal and rectal progesterone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
277

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

March 12, 2018

Last Update Submit

September 9, 2019

Conditions

Infertility

Keywords

ProgesteroneHRTfrozen embryo transfer

Outcome Measures

Primary Outcomes (1)

  • ongoing pregnancy

    gestational week 12

    4 month

Secondary Outcomes (2)

  • pregnancy rate

    4 month

  • Pregnancy loss

    4 month

Interventions

ProgesteroneDRUG

6 mg estradiol and vaginal and rectal progesterone

Also known as: estradiol

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Autologuos spare embryos from previous IVF/ICSI cycles.

You may qualify if:

  • Frozen embryo transfer cycles in HRT cycles

You may not qualify if:

  • Donor frozen embryo transfer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Clinic Regional Hospital Skive

Skive, 7800, Denmark

Location

MeSH Terms

Conditions

Infertility

Interventions

ProgesteroneEstradiol

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid HormonesEstrenesEstranesEstradiol Congeners

Study Officials

  • Peter Humaidan, DMsc

    Fertility Clinic Skive

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 20, 2018

Study Start

February 1, 2018

Primary Completion

February 1, 2019

Study Completion

September 1, 2019

Last Updated

September 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)