Unexplained Infertility/ sub fertility
Conditions
Interventions
Exogenous progesterone (Utrogestan)
Sponsors
ZonMW
Eligibility
Inclusion criteria
Inclusion criteria: - Couples starting IUI with Mild Ovarian HyperStimulation (MOH), with the intend to receive this treatment for at least six months. - Diagnosis of unexplained (primary or secondary) infertility - Hunault 30%, after an expectant management period of at least 6 additional months). - Females aged >18 years with regular menstrual cycle. - Total mobile sperm count (VCM) >10 million.
Exclusion criteria
Exclusion criteria: - Uterine anomalies - Endometriosis gr 3-4 - Endocrine anomalies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy within 6 months of treatment, leading to Live birth. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical pregnancy rate (Number and rate op patients that achieve a clinical pregnancy within 6 months). Miscarriage rate (Number and rate of patients that experience a miscarriage (16 weeks gestation), gestational diabetes, preeclampsia, HELLP syndrome or pregnancy induced hypertension, within one year). Perinatal outcomes (stillbirth, live birth, perinatal death <6 weeks, gestational age and birthweight). Side effects (e.g. nausea, stomach ache, vaginal discharge, other (self reported) side effects) within treatment cycle) and compliance to therapy (use of medication as prescribed during treatment cycles). Added Medication Costs (increase in total therapy costs due to the addition of utrogestan). Budget impact (economic assessment that estimates financial consequences of adopting a new intervention). | — |
Contacts
Public ContactKatja Drechsel
UMC Utrecht
Outcome results
None listed