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Daytime Profile of Salivary Progesterone

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ClinicalTrials.gov Identifier: NCT03725904
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
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

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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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03725904


Locations
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Denmark
Fertility Clinic Regional Hospital Skive Recruiting
Skive, Denmark, 7800
Contact: Birgit Alsbjerg, M.D.    +45 78 44 57 60    birgit.alsbjerg@midt.rm.dk   
Contact: Alice Mikkelsen       Alice.Toft.Mikkelsen@midt.rm.dk   
Principal Investigator: Birgit Alsbjerg, M.D.         
Sponsors and Collaborators
Peter Humaidan
Boston IVF

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Responsible Party: Peter Humaidan, Professor, Regionshospitalet Viborg, Skive
ClinicalTrials.gov 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

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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:
Progesterone
Saliva
IVF
Frozen embryo transfer

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