Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients (SALIVA_MINT)

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status: Completed

Conditions: Infertility, Female; Reproductive Sterility

Treatments: Diagnostic Test: Determination of progesterone and oestradiol

Study type: Interventional

Funder types: Other

Identifiers

NCT05184777

2107-VLC-071-EB

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Patients undergoing ovarian stimulation for IVF/ICSI

Experimental group

Description:

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).

Treatment:

Diagnostic Test: Determination of progesterone and oestradiol

Patients for embryo transfer (ET) undergoing hormonal replacement therapy

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Determination of progesterone and oestradiol