Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients

Infertility, Female Clinical Trial

— SALIVA_MINT  

Official title:

Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05184777
• Other study ID #: 2107-VLC-071-EB
• Status: Completed
• Phase: N/A
• Start date: February 3, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: February 2023
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In assisted reproductive treatment (ART), it is necessary to follow closely the stimulation cycles of patients undergoing these treatments in order to monitor the number and size of developing follicles. Oestradiol (E2) and progesterone (P) are products of steroidogenesis and the concentrations of both hormones increase with the diameter of the growing follicle and accurate and reliable methods to measure E2 and P are essential to assess treatment response and support clinical decision. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients to undergo multiple blood draws. It is often a physically and emotionally painful process and the most convenient solution to this problem is the measurement of hormone concentration in other biological fluids. Salivary diagnostic tests are a less invasive, inexpensive and stress-free alternative to measurements of hormone concentration in other biological fluids. The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients. In addition, secondary objectives include the measurement of diurnal variability of salivary hormone levels and patient experience with saliva collection as users.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 20, 2023
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients undergoing IVF/ICSI treatment
• Patients planned to embryo transfer (ET) undergoing hormonal replacement therapy
• Aged from18-45 years old.
• BMI 19-30 kg/m2
• Signed written informed consent

Exclusion Criteria:

• Patients suffering for any systemic disease or endocrine disorder will be excluded foe the study

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Reproductive Sterility

Intervention

Diagnostic Test:
• Determination of progesterone and oestradiol
Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.

Locations

Country	Name	City	State
Spain	IVI Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA	MINT DIAGNOSTICS

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients.	between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations	12 months
Secondary	Diurnal variability of salivary progesterone and oestradiol levels	Measurement of progesterone and oestradiol levels	12 months
Secondary	Patient User Experience with saliva collection	Registry of patient experience with saliva collection as users using a specific questionary. (Yes/No question)	12 months