Back to resultsDaytime Profile of Salivary Progesterone
Primary Purpose
Infertility, Female
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Progesterone analysis in saliva
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility, Female focused on measuring Progesterone, Saliva, IVF, Frozen embryo transfer
Eligibility 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
Sites / Locations
- Fertility Clinic Regional Hospital Skive
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IVF/FET
Arm Description
Outcomes
Primary Outcome Measures
Levels of free progesterone in saliva
Secondary Outcome Measures
Clinical pregnancy rate
Ultrasound detected gestational sack divided with number of embryo transfer
Ongoing pregnancy rate
Viable pregnancy after gestational week 12+0
Full Information
NCT ID
NCT03725904
First Posted
October 26, 2018
Last Updated
January 18, 2020
Sponsor
Peter Humaidan
Collaborators
Boston IVF
1. Study Identification
Unique Protocol Identification Number
NCT03725904
Brief Title
Daytime Profile of Salivary Progesterone
Official Title
Daytime Profile of Salivary Progesterone During the Mid-luteal Phase of IVF and FET Cycles
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 24, 2018 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Humaidan
Collaborators
Boston IVF
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
Progesterone, Saliva, IVF, Frozen embryo transfer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IVF/FET
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Progesterone analysis in saliva
Intervention Description
Analysis of salava progesterone
Primary Outcome Measure Information:
Title
Levels of free progesterone in saliva
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Ultrasound detected gestational sack divided with number of embryo transfer
Time Frame
8 weeks
Title
Ongoing pregnancy rate
Description
Viable pregnancy after gestational week 12+0
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Fertility Clinic Regional Hospital Skive
City
Skive
ZIP/Postal Code
7800
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Daytime Profile of Salivary Progesterone
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