NCT03725904

Brief Summary

The aim of this study is to perform a 12-hour profile of free saliva progesterone during the luteal phase after fresh and frozen embryo transfer. If progesterone levels in saliva samples show a constant level during daytime, this non-invasive measurement can be used in future ART patients with insufficient progesterone levels who might benefit from additional exogenous progesterone supplementation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 22, 2020

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

October 26, 2018

Last Update Submit

January 18, 2020

Conditions

Infertility, Female

Keywords

ProgesteroneSalivaIVFFrozen embryo transfer

Outcome Measures

Primary Outcomes (1)

  • Levels of free progesterone in saliva

    12 hours

Secondary Outcomes (2)

  • Clinical pregnancy rate

    8 weeks

  • Ongoing pregnancy rate

    12 weeks

Study Arms (1)

IVF/FET

EXPERIMENTAL
Diagnostic Test: Progesterone analysis in saliva

Interventions

Progesterone analysis in salivaDIAGNOSTIC_TEST

Analysis of salava progesterone

IVF/FET

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • One or two good quality embryos for transfer on day 5.
  • BMI \>18,5 \<30 kg/m²

You may not qualify if:

  • No good quality embryos for transfer
  • Uterine abnormalities
  • One ovary
  • Oocyte donation

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, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2018

First Posted

October 31, 2018

Study Start

October 24, 2018

Primary Completion

April 3, 2019

Study Completion

January 1, 2020

Last Updated

January 22, 2020

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)