Needle-Free Monitoring for IVF Patient Cycles

• Conditions: Infertility

• Registration Number: NCT03162809
• Lead Sponsor: Boston IVF

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-04-11
• Study Start: 2017-05-09
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12
• Primary Completion: 2021-04
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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.

Read More

Exclusion Criteria

-Prior cancelled cycle due to hyperstimulation.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of multiple Progesterone levels as an aid during an IVF cycle	1 month	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of salivary Estradiol level as an aid during fertility treatment	1 month	Comparison of salivary reproductive hormone values versus serum collection to see if there is a correlation between the two methods of collection.
Measurement of salivary Progesterone level as an aid during fertility treatment	1 month	Comparison of salivary reproductive hormone values versus serum collection to see if there is a correlation between the two methods of collection.

Trial Locations

Locations (1)

Boston IVF; 🇺🇸 Waltham, Massachusetts, United States