SALIVA_MINT: Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients

Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA (Other)
Overall Status
Recruiting
CT.gov ID
NCT05184777
Collaborator
MINT DIAGNOSTICS (Other)
120
1
2
22.9
5.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Determination of progesterone and oestradiol
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective unicentric studyProspective unicentric study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients
Actual Study Start Date :
Feb 3, 2022
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients undergoing ovarian stimulation for IVF/ICSI

90 patients undergoing ovarian stimulation for IVF/ICSI; Low, average and high responders will be included in equal proportions, in order to cover the widest range of hormonal values (30 blood and saliva samples per ovarian stimulation point will be taken for determination of progesterone and oestradiol).

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

Experimental: Patients for embryo transfer (ET) undergoing hormonal replacement therapy

30 patients for embryo transfer (ET) undergoing hormonal replacement therapy. These patients will only have a progesterone determination in their blood and saliva samples on the day of ET.

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

Outcome Measures

Primary Outcome Measures

  1. To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients. [12 months]

    between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations

Secondary Outcome Measures

  1. Diurnal variability of salivary progesterone and oestradiol levels [12 months]

    Measurement of progesterone and oestradiol levels

  2. Patient User Experience with saliva collection [12 months]

    Registry of patient experience with saliva collection as users using a specific questionary. (Yes/No question)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IVI Valencia Valencia Spain 46003

Sponsors and Collaborators

  • Instituto Valenciano de Infertilidad, IVI VALENCIA
  • MINT DIAGNOSTICS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT05184777
Other Study ID Numbers:
  • 2107-VLC-071-EB
First Posted:
Jan 11, 2022
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022