Daytime Profile of Salivary Progesterone

Daytime Profile of Salivary Progesterone During the Mid-luteal Phase of IVF and FET Cycles

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.

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Diagnostic test: Progesterone analysis in saliva

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Skive, Denmark, 7800
    • Fertility Clinic Regional Hospital Skive

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVF/FET	Diagnostic test: Progesterone analysis in saliva; Analysis of salava progesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Levels of free progesterone in saliva	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	Ultrasound detected gestational sack divided with number of embryo transfer	8 weeks
Ongoing pregnancy rate	Viable pregnancy after gestational week 12+0	12 weeks

Collaborators and Investigators

• Sponsor: Peter Humaidan
• Collaborators: Boston IVF

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2018
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 18, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: IVF; Frozen embryo transfer; Saliva; Progesterone
• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: Saliva1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No