Working... Menu

Daytime Profile of Salivary Progesterone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03725904
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Boston IVF
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive

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.

Condition or disease Intervention/treatment Phase
Infertility, Female Diagnostic Test: Progesterone analysis in saliva Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Daytime Profile of Salivary Progesterone During the Mid-luteal Phase of IVF and FET Cycles
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IVF/FET Diagnostic Test: Progesterone analysis in saliva
Analysis of salava progesterone

Primary Outcome Measures :
  1. Levels of free progesterone in saliva [ Time Frame: 12 hours ]

Secondary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 8 weeks ]
    Ultrasound detected gestational sack divided with number of embryo transfer

  2. Ongoing pregnancy rate [ Time Frame: 12 weeks ]
    Viable pregnancy after gestational week 12+0

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18-45 years
  • One or two good quality embryos for transfer on day 5.
  • BMI >18,5 <30 kg/m²

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03725904

Layout table for location information
Fertility Clinic Regional Hospital Skive Recruiting
Skive, Denmark, 7800
Contact: Birgit Alsbjerg, M.D.    +45 78 44 57 60   
Contact: Alice Mikkelsen   
Principal Investigator: Birgit Alsbjerg, M.D.         
Sponsors and Collaborators
Peter Humaidan
Boston IVF

Layout table for additonal information
Responsible Party: Peter Humaidan, Professor, Regionshospitalet Viborg, Skive Identifier: NCT03725904     History of Changes
Other Study ID Numbers: Saliva1
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peter Humaidan, Regionshospitalet Viborg, Skive:
Frozen embryo transfer

Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs