Clinical Trials Directory

Trials / Completed

CompletedNCT05987657

Assessment of Two Methods for Progesterone Dosage During IVF

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
Female
Age
18 Years – 43 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTSalivary and blood progesterone dosageSalivary 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.

Timeline

Start date
2023-11-15
Primary completion
2024-11-09
Completion
2024-11-09
First posted
2023-08-14
Last updated
2025-01-24

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05987657. Inclusion in this directory is not an endorsement.