infertility, Unexplained Subfertility
Conditions
Brief summary
Pregnancy occurring within 6 months after randomization, leading to Live birth
Detailed description
Clinical pregnancy, ongoing pregnancy, biochemical pregnancy loss and miscarriage rates within 6 months after randomisation., For each participant, number of MOH-IUI cycles initiated, completed and cancelled are evaluated within 6 months after randomisation., Of all achieved (ongoing) pregnancies occurring within 6 months after randomization (including spontaneous pregnancies) the following outcomes are assessed; multiple pregnancy rate, time to pregnancy, 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 randomization., Quality of life assessed at time of randomization, and 6 and 18 months after randomization, using the FertiQoL questionnaire, Progression to IVF/ICSI within six months after randomization, 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, costs and quality of life.
Interventions
DRUGUtrogestan 300 mjuk vaginalkapsel
DRUGThe used Placebo in this trial is Placebo 300mg soft capsule
DRUGin order to match the corresponding active product.
The placebo
DRUGsoft capsule
DRUGis an oblong
DRUGslightly yellow capsule containing a whitish 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 progesterone drug substance and with appropriately compensating quantities of some excipients.
Manufacturing site of the placebo is the same as the actives (Cyndea)
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy occurring within 6 months after randomization, leading to Live birth | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical pregnancy, ongoing pregnancy, biochemical pregnancy loss and miscarriage rates within 6 months after randomisation., For each participant, number of MOH-IUI cycles initiated, completed and cancelled are evaluated within 6 months after randomisation., Of all achieved (ongoing) pregnancies occurring within 6 months after randomization (including spontaneous pregnancies) the following outcomes are assessed; multiple pregnancy rate, time to pregnancy, 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 randomization., Quality of life assessed at time of randomization, and 6 and 18 months after randomization, using the FertiQoL questionnaire, Progression to IVF/ICSI within six months after randomization, Use of ART and (ongoing) pregnancy achieved after the six-month study period and within 12 months follow up., Budget impact | — |
Countries
Netherlands
Outcome results
None listed