Daytime Profile of Salivary Progesterone

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725904
• Other study ID #: Saliva1
• Status: Completed
• Phase: N/A
• Start date: October 24, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: October 2018
• Source: Regionshospitalet Viborg, Skive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 1, 2020
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Diagnostic Test:
• Progesterone analysis in saliva
Analysis of salava progesterone

Locations

Country	Name	City	State
Denmark	Fertility Clinic Regional Hospital Skive	Skive

Sponsors (2)

Lead Sponsor	Collaborator
Peter Humaidan	Boston IVF

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of free progesterone in saliva		12 hours
Secondary	Clinical pregnancy rate	Ultrasound detected gestational sack divided with number of embryo transfer	8 weeks
Secondary	Ongoing pregnancy rate	Viable pregnancy after gestational week 12+0	12 weeks