Assessment of Two Methods for Progesterone Dosage During IVF

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Femme Mère Enfant

Bron, Rhône, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Salivary and blood progesterone dosage

Diagnostic Test

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.

Primary outcomes

Reliability of salivary dosage of progesterone compared to blood sample.

Time frame: At the inclusion

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: SALIPROG

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Aug 14, 2023
Registry last updated: Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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