SALIPROG: Assessment of Two Methods for Progesterone Dosage During IVF

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05987657

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Diagnostic Test: Salivary and blood progesterone dosage	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Comparison of Two Methods to Assess Progesterone Concentration in Patient During IVF Protocol on Triggering Day: Salivary Versus Blood Test

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Salivary and blood progesterone dosage IVF patients with fresh embryo transfer having a dosage of progesterone, salivary and blood, on triggering day	Diagnostic Test: Salivary and blood progesterone dosage Salivary dosage: patient will chew a dry swab for 2 minutes; when the swab is soaked it is put back in its small case and sent to the laboratory for analysis. In parallel, the same patients will have a blood sample of 4 ml to dose blood progesterone on an EDTA tube. It will be also sent to the laboratory for analysis. Both analyses will be done only once on triggering day meaning 36 hours before oocyte retrieval.

Arm

Intervention/Treatment

Other: Salivary and blood progesterone dosage

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

Diagnostic Test: Salivary and blood progesterone dosage

Salivary dosage: patient will chew a dry swab for 2 minutes; when the swab is soaked it is put back in its small case and sent to the laboratory for analysis. In parallel, the same patients will have a blood sample of 4 ml to dose blood progesterone on an EDTA tube. It will be also sent to the laboratory for analysis. Both analyses will be done only once on triggering day meaning 36 hours before oocyte retrieval.

Outcome Measures

Primary Outcome Measures

Reliability of salivary dosage of progesterone compared to blood sample. [At the inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 43 Years

Sexes Eligible for Study:

Female

Accepts 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)