NCT03162809

Brief Summary

Salivary diagnostic testing is emerging as a less invasive, inexpensive alternative to serum analyte measurements with proven diagnostic accuracy in clinical settings. This study aims to continue analyzing aspects of the performance of salivary hormone competitive immunoassays for monitoring patient's reproductive hormone profiles in the reproductive cycle. Hormone levels will be monitored during treatment cycles for infertility.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

May 9, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

3.9 years

First QC Date

April 11, 2017

Last Update Submit

August 11, 2020

Conditions

Infertility

Keywords

infertilityin vitro fertilizationEstradiolProgesterone

Outcome Measures

Primary Outcomes (1)

  • Measurement of multiple Progesterone levels as an aid during an IVF cycle

    To determine if collecting multiple salivary Progesterone levels versus a single serum hormone sample could assist in predicting the administration of Human Chorionic Gonadotropin (HCG) during an IVF cycle.

    1 month

Secondary Outcomes (2)

  • Measurement of salivary Estradiol level as an aid during fertility treatment

    1 month

  • Measurement of salivary Progesterone level as an aid during fertility treatment

    1 month

Eligibility Criteria

Age25 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center

You may qualify if:

  • Diagnosis of infertility.
  • Cycle start age of 25 -43 years.
  • Undergoing controlled ovarian stimulation for IVF.
  • All monitoring scheduled at the participating IVF facility.

You may not qualify if:

  • Prior cancelled cycle due to hyperstimulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Denny Sakkas, PhD

    Boston IVF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2017

First Posted

May 22, 2017

Study Start

May 9, 2017

Primary Completion

April 1, 2021

Study Completion

June 1, 2021

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)