Needle-Free Monitoring for IVF Patient Cycles

Infertility Clinical Trial

Official title:

Venopuncture-Free Monitoring During IVF: Are More Frequent Sequential Salivary Hormone Measurements More Informative Than Daily Serum Monitoring of IVF Patients?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03162809
• Other study ID #: SAL201702
• Status: Active, not recruiting
• Start date: May 9, 2017
• Est. completion date: June 2021

Study information

• Verified date: August 2020
• Source: Boston IVF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 43 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
United States	Boston IVF	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston IVF

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of salivary Estradiol level as an aid during fertility treatment	Comparison of salivary reproductive hormone values versus serum collection to see if there is a correlation between the two methods of collection.	1 month
Secondary	Measurement of salivary Progesterone level as an aid during fertility treatment	Comparison of salivary reproductive hormone values versus serum collection to see if there is a correlation between the two methods of collection.	1 month