Daytime Profile of Salivary Progesterone | NCT03725904

Studies
Daytime Profile of Salivary Progesterone

NCT03725904

Sponsor

Peter Humaidan

Status

Completed

Last Update Posted

Jan 22, 2020Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Infertility, Female

Interventions

Progesterone analysis in saliva

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 24, 2018Actual

Primary Completion Date

Apr 3, 2019Actual

Completion Date

Jan 1, 2020Actual

First Submitted Date

Oct 26, 2018

First Submission Date that Met QC Criteria

Oct 29, 2018

First Posted Date

Oct 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2020

Last Update Posted Date

Jan 22, 2020Actual

Name	Class
Boston IVF	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IVF/FET	Experimental		Diagnostic Test: Progesterone analysis in saliva

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Progesterone analysis in saliva	Diagnostic Test	Analysis of salava progesterone	IVF/FET

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fertility Clinic Regional Hospital Skive		Skive		7800	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007247	Infertility, Female

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided