Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients

Not Applicable

Completed

• Conditions: Infertility, Female; Reproductive Sterility
• Interventions: Diagnostic Test: Determination of progesterone and oestradiol

• Registration Number: NCT05184777
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2021-12-22
• Study First Posted: 2022-01-11
• Study Start: 2022-02-03
• Primary Completion: 2022-05-17
• Status Verified: 2023-02
• Study Completion: 2023-02-20
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients undergoing ovarian stimulation for IVF/ICSI	Determination of progesterone and oestradiol	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).
Patients for embryo transfer (ET) undergoing hormonal replacement therapy	Determination of progesterone and oestradiol	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Diurnal variability of salivary progesterone and oestradiol levels	12 months	Measurement of progesterone and oestradiol levels
Patient User Experience with saliva collection	12 months	Registry of patient experience with saliva collection as users using a specific questionary. (Yes/No question)

Trial Locations

Locations (1)

IVI Valencia; 🇪🇸 Valencia, Spain