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Disease/health condition -
Endocrine disorders
Progesterone
Assay format
Immunoassay
Information History
First added in 2020
Purpose type
Montoring
Purpose
To confirm ovulation during infertility evaluation and treatment
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN
54324
Progesterone IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of progesterone in a clinical specimen, using an enzyme immunoassay (EIA) method.
The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024EMDN
W0102050106
PROGESTERONE
The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdnWHO supporting publications
N/A
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended including the progesterone test category in the third EDL:
• as a disease-specific IVD for use in clinical laboratories (EDL 3, Section II.b, within a new subsection for endocrine disorders);
• using an immunoassay format;
• to confirm ovulation during infertility evaluation and treatment. The group requested the addition of a note to the test category entry in the EDL stating that it is only recommended for use in specialized health care settings. The group further requested the submission of testosterone as a potential addition to the EDL, for full review and consideration next year.
• as a disease-specific IVD for use in clinical laboratories (EDL 3, Section II.b, within a new subsection for endocrine disorders);
• using an immunoassay format;
• to confirm ovulation during infertility evaluation and treatment. The group requested the addition of a note to the test category entry in the EDL stating that it is only recommended for use in specialized health care settings. The group further requested the submission of testosterone as a potential addition to the EDL, for full review and consideration next year.
The consequences of infertility from a personal and social point of view can be dramatic. Fertility is considered a major public health issue by WHO. Progesterone forms part of international guidelines and best practice to determine whether ovulation has taken place during infertility evaluation and treatment. Importantly, guidelines do not commonly support its use to assess luteal phase deficiency (LPD), or as the primary assessment tool to diagnose amenorrhoea or menstrual irregularities due to hypogonadism, hyperprolactinaemia, thyroid dysfunction or late-onset congenital adrenal hyperplasia.
Because progesterone testing has such limited indications, it is particularly prone to overuse. SAGE IVD emphasized that progesterone testing and result interpretation require appropriate laboratory infrastructure and the availability of fertility or endocrinology specialists.
The serum progesterone test is aimed at aiding the diagnosis of disorders related to reproductive dysfunction, more specifically infertility and anovulation, luteal phase deficiency (LPD) and polycystic ovary syndrome (PCOS). No evidence is presented on the diagnostic accuracy or clinical utility of the serum progesterone test for these three conditions. Evidence provided shows that a single low-progesterone measurement for women in early pregnancy presenting with bleeding or pain and inconclusive ultrasound results can rule out a viable pregnancy.
World Health Organization. (2021). The selection and use of essential in vitro diagnostics: report of the third meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2020 (including the third WHO model list of essential in vitro diagnostics). World Health Organization. https://iris.who.int/handle/10665/339064