Daytime Profile of Salivary Progesterone

• Sponsor: Peter Humaidan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03725904
• Collaborator: Boston IVF (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 14.3
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Diagnostic Test: Progesterone analysis in saliva	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• 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: Oct 24, 2018
• Actual Primary Completion Date: Apr 3, 2019
• Actual Study Completion Date: Jan 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Levels of free progesterone in saliva [12 hours]

Secondary Outcome Measures

1. Clinical pregnancy rate [8 weeks]

   Ultrasound detected gestational sack divided with number of embryo transfer

2. Ongoing pregnancy rate [12 weeks]

   Viable pregnancy after gestational week 12+0

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fertility Clinic Regional Hospital Skive	Skive		Denmark	7800

Sponsors and Collaborators

• Peter Humaidan
• Boston IVF

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Humaidan, Professor, Regionshospitalet Viborg, Skive
• ClinicalTrials.gov Identifier: NCT03725904
• Other Study ID Numbers: Saliva1
• First Posted: Oct 31, 2018
• Last Update Posted: Jan 22, 2020
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peter Humaidan, Professor, Regionshospitalet Viborg, Skive: Progesterone; Saliva; IVF; Frozen embryo transfer
• Additional relevant MeSH terms: Infertility; Infertility, Female; Progesterone

Study Results

No Results Posted as of Jan 22, 2020