Needle-Free Monitoring for IVF Patient Cycles

NCT ID: NCT03162809

Last Updated: 2020-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-09

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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This study will be a prospective study to measure salivary and serum estrogen and progesterone levels in subject's voluntarily undergoing monitored infertility treatment cycles including controlled ovarian stimulation (COS) with oral agents or gonadotropins and controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF). Ultimately, the potential applicability and reliability of salivary steroid monitoring in IVF cycles will be assessed.

Conditions

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Infertility

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-Prior cancelled cycle due to hyperstimulation.
Minimum Eligible Age

25 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boston IVF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denny Sakkas, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston IVF

Locations

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Boston IVF

Waltham, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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SAL201702

Identifier Type: -

Identifier Source: org_study_id

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