Daytime Profile of Salivary Progesterone

Not Applicable

Completed

• Conditions: Infertility, Female
• Interventions: Diagnostic Test: Progesterone analysis in saliva

• Registration Number: NCT03725904
• Lead Sponsor: Peter Humaidan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-24
• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Primary Completion: 2019-04-03
• Study Completion: 2020-01-01
• Last Update Submitted: 2020-01-18
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IVF/FET	Progesterone analysis in saliva	-

Primary Outcome Measures

Name	Time	Method
Levels of free progesterone in saliva	12 hours

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	8 weeks	Ultrasound detected gestational sack divided with number of embryo transfer
Ongoing pregnancy rate	12 weeks	Viable pregnancy after gestational week 12+0

Trial Locations

Locations (1)

Fertility Clinic Regional Hospital Skive; 🇩🇰 Skive, Denmark