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

Primary Purpose

Infertility

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Salivary and blood progesterone dosage
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility focused on measuring Progesterone concentration, salivary test, In vitro fertilization, infertility

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept 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)

Sites / Locations

  • Hospital Femme Mère Enfant

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Salivary and blood progesterone dosage

Arm Description

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

Outcomes

Primary Outcome Measures

Reliability of salivary dosage of progesterone compared to blood sample.

Secondary Outcome Measures

Full Information

First Posted
July 28, 2023
Last Updated
August 4, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05987657
Brief Title
Assessment of Two Methods for Progesterone Dosage During IVF
Acronym
SALIPROG
Official Title
Comparison of Two Methods to Assess Progesterone Concentration in Patient During IVF Protocol on Triggering Day: Salivary Versus Blood Test
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Progesterone concentration, salivary test, In vitro fertilization, infertility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Salivary and blood progesterone dosage
Arm Type
Other
Arm Description
IVF patients with fresh embryo transfer having a dosage of progesterone, salivary and blood, on triggering day
Intervention Type
Diagnostic Test
Intervention Name(s)
Salivary and blood progesterone dosage
Intervention Description
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 Outcome Measure Information:
Title
Reliability of salivary dosage of progesterone compared to blood sample.
Time Frame
At the inclusion

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eloise FRAISON, Dr
Phone
04 72 12 94 12
Ext
+33
Email
eloise.fraison@chu-lyon.fr
Facility Information:
Facility Name
Hospital Femme Mère Enfant
City
Bron
State/Province
Rhône
ZIP/Postal Code
69500
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eloise FRAISON, Dr
Phone
04 72 12 94 12
Ext
+33
Email
eloise.fraison@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Eloise FRAISON, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of Two Methods for Progesterone Dosage During IVF

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