Assessment of Two Methods for Progesterone Dosage During IVF

Infertility Clinical Trial

— SALIPROG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987657
• Other study ID #: 69HCL23_0644
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: January 15, 2025

Study information

• Verified date: November 2023
• Source: Hospices Civils de Lyon
• Contact: Eloise FRAISON, Dr
• Phone: 04 72 12 94 12
• Email: eloise.fraison[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
France	Hospital Femme Mère Enfant	Bron	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability of salivary dosage of progesterone compared to blood sample.		At the inclusion