Needle-Free Monitoring for IVF Patient Cycles

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03162809

Enrollment

300

Registered

2017-05-22

Start date

2017-05-09

Completion date

2021-06-30

Last updated

2020-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

infertility, in vitro fertilization, Estradiol, Progesterone

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 43 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results