Progesterone Luteal Support in Unexplained Infertility Management (PLUIM study)

2026-525747-33-00 · tracked via the Priya Life Science EU tracker

Sponsor

Universitair Medisch Centrum Utrecht

Sponsor type

Hospital/Clinic/Other health care facility

Therapeutic area

Reproductive and Urinary Physiological Phenomena

Decision date

30/06/2026

Enrollment target

640

Sites

Netherlands

Condition studied

unexplained subfertillity, infertillity

Investigational medicinal product(s)

Utrogestan 300 mg soft vaginal capsulesThe used placebo in this tial in placebo 300mg soft capsuelin order to match the corresponding active product. The placebo soft capsule is an oblongslightly yellow capsule containing a whitich oily solution. The placebo presentation is modelled on the corresponding active presentation for the purposes of blinding the imps. The manufacture and control of the placebo is essentially the same as for the activebut without proesterone drug substance and with appropriately compensating quantitites of some excipients. Manufacturing site of the placebo is the same as the actives (cyndea)

Eligibility

Age group

18-64 years

Sex

Female

Primary endpoint

Pregnancy occurring within 6 months after randomisation, leading to a live birth.

Endpoint detail

Clinical pregnancy, ongoing pregnancy, biochemical pregnancy loss and miscarriage rates within 6 months after randomisation., Of all achieved (ongoing) pregnancies occurring within 6 months after randomisation the following outcomes are assessed; multiple pregnancy rate, time to pregnancy, pregnancy loss, pregnancy complications, perinatal outcomes, type of delivery and outcomes., Side effects and compliance to therapy assessed during treatment using a medication dairy and a questionnaire, send out 6 months after randomisation., Number of adverse events and serious adverse events, Quality of life assessed at time of randomisation, and 6 and 18 months after randomisation, using the FertiQoL questionnaire., Progression to (MOH)IUI/IVF/ICSI within six months after randomisation., Use of ART and (ongoing) pregnancy achieved after the six-month study period and within 12 months follow up., Budget impact, Cost-effectiveness analyses using live birth rates and costs.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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