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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05987657
Acronym
SALIPROG
Enrollment
50
Registered
2023-08-14
Start date
2023-11-15
Completion date
2024-11-09
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Progesterone concentration, salivary test, In vitro fertilization, infertility

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.

Interventions

DIAGNOSTIC_TESTSalivary 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Reliability of salivary dosage of progesterone compared to blood sample.At the inclusion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026