NCT05323513

Brief Summary

The study design is an observational cohort study. Level of serum P4 will be collected on day OR+4 as well as on the day of embryo transfer (ET) either day OR+3 or OR+5.

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
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration 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

March 10, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

April 4, 2022

Last Update Submit

July 5, 2023

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Live birth rate in relation to luteal serum progesterone levels on day four and three or five

    The birth of a live born child after gestational week 22+0

    9-24 months after inclusion

Secondary Outcomes (2)

  • Pregnancy rate in relation to luteal serum progesterone levels

    14-16 days after oocyte retrieval

  • Clinical pregnancy rate in relation to luteal serum progesterone levels

    7-9 weeks after inclusion

Eligibility Criteria

Age18 Years - 41 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients treated at The Fertility Clinic, Regional Hospital in Skive, who meets the inclusion criteria will be invited to participate in the study.

You may qualify if:

  • Signed informed consent
  • BMI \<35kg/m2

You may not qualify if:

  • No fresh embryo transfer
  • Prior participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertilitetsklinikken, Regionshospitalet Skive

Skive, 7800, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Peter Humaidan, Professor

    Fertilitetsklinikken, Regionshospitalet Skive

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Humaidan, Professor

CONTACT

78445760peter.humaidan@midt.rm.dk

Study Design

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

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 12, 2022

Study Start

March 10, 2022

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

July 6, 2023

Record last verified: 2023-07

Locations

DK(1)