Assessment of Two Methods for Progesterone Dosage During IVF (SALIPROG)

Civil Hospices of Lyon

Status: Completed

Conditions: Infertility

Treatments: Diagnostic Test: Salivary and blood progesterone dosage

Study type: Interventional

Funder types: Other

Identifiers

NCT05987657

69HCL23_0644

Details and patient eligibility

About

Nowadays, 1/7 couple consult because of infertility and some of them will need in vitro fertilization +/- intracytoplasmic sperm injection (IVF+/- ICSI). The IVF process includes a 14 days stimulation with FSH +/- LH in an agonist or antagonist protocol. The monitoring consists of regular ultrasound scan and blood sample. During the stimulation protocol many test have been proposed to predict the success of IVF. However, progesterone dosage on triggering day seems to be the only relevant exam. Indeed, when the progesterone blood concentration is low, the pregnancy rate is decreased. The only way to obtain progesterone concentration is a blood sample. The IVF journey is known to be stressful with many injections. Therefore, the salivary dosage appear to be more patient friendly. This kind of dosage has already been studied yet never use in routine because of a lack of repeatability. The laboratory of Lyon has developed a new technique to overcome this issue by using a liquid chromatography-mass spectrometry.

The aim of this work is as a first step to assess the repeatability, reliability and precision of salivary dosage on triggering day for IVF patient compared to blood concentration of progesterone.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients between 18 and under 43 years old
• in the course of IVF more or less ICSI of the PMA service of the HFME with transfer of fresh embryo
• Signature of an express consent
• Understanding the French language, both oral and written.
• Affiliated to a social security scheme

Exclusion criteria

• Persons deprived of their liberty by a judicial or administrative decision
• Persons subject to psychiatric care
• Persons admitted to a health or social establishment for purposes other than research
• Participants in another study that could impact the results of the present study, in particular those related to the level of progesterone.
• Adults subject to a legal protection measure (guardianship, curatorship)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Salivary and blood progesterone dosage

Other group

Description:

IVF patients with fresh embryo transfer having a dosage of progesterone, salivary and blood, on triggering day

Treatment:

Diagnostic Test: Salivary and blood progesterone dosage