Assessment of Two Methods for Progesterone Dosage During IVF

NCT05987657 | Completed

• 1 other identifier: 69HCL23_0644
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Progesterone concentration; salivary test; In vitro fertilization; infertility

Outcome Measures

Primary Outcomes (1)

• Reliability of salivary dosage of progesterone compared to blood sample.

  At the inclusion

Study Arms (1)

Salivary and blood progesterone dosage

OTHER

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

Diagnostic Test: Salivary and blood progesterone dosage

Interventions

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.

Salivary and blood progesterone dosage

Eligibility Criteria

• Age: 18 Years - 43 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospital Femme Mère Enfant

Bron, Rhône, 69500, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 14, 2023
• Study Start: November 15, 2023
• Primary Completion: November 9, 2024
• Study Completion: November 9, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)