Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients

NCT ID: NCT05184777

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-03
• Study Completion Date: 2023-02-20

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.

Conditions

Infertility, Female; Reproductive Sterility

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Determination of progesterone and oestradiol

Intervention Type: DIAGNOSTIC_TEST

Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.

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.

Group Type: EXPERIMENTAL

Determination of progesterone and oestradiol

Intervention Type: DIAGNOSTIC_TEST

Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.

Interventions

Determination of progesterone and oestradiol

Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MINT DIAGNOSTICS

UNKNOWN

Sponsor Role: collaborator

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IVI Valencia

Valencia, , Spain

Countries

Spain

Other Identifiers

2107-VLC-071-EB

Identifier Type: -

Identifier Source: org_study_id