Progesterone Luteal Support in Unexplained Infertility Management (PLUIM study)

Conditions

infertillity, unexplained subfertillity

Brief summary

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

Detailed description

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.

Related papers

No related papers found yet.

Interventions

DRUGUtrogestan 300 mg soft vaginal capsules

DRUGThe used placebo in this tial in placebo 300mg soft capsuel

DRUGin order to match the corresponding active product. The placebo soft capsule is an oblong

DRUGslightly 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 active

DRUGbut 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

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Pregnancy occurring within 6 months after randomisation, leading to a live birth.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Outcome results

None listed