Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUMC Utrecht
About this trial
The LUMO study is a multicenter, randomized controlled trial that evaluates the effectivity of luteal phase support in MOH/IUI treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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% (or >30%, after an expectant management period of at least 6 additional months).
Females aged >18 years with regular menstrual cycle.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Progesterone Vaginal Product
Drug3dd200mg
Placebo
Drug3dd1 vaginal capsule
Treatment groups
1,008 Participants
are divided into 2 treatment groupsGroup A: MOH/IUI treatment with LPSExperimental treatment 1 intervention
Group B: MOH/IUI treatment with placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Live Birth
Pregnancy leading to Live birth within six months.
Time frame
6 monthsSecondary outcomes
1
Clinical pregnancy rate
Number and rate of patients that achieve a clinical pregnancy within six months
Time frame
<6 months2
Miscarriage rate
Number and rate of patients that experience miscarriage (gestation \<16weeks) within six months
Time frame
<6 months3
Multiple pregnancy rate
Number of pregnancies with 2 or more fetuses
Time frame
<6 months4
Pregnancy complications
Pregnancies complicated by preterm labor (\<37 weeks), loss of pregnancy (\>16weeks), gestational diabetes, preeclampsia, HELLP syndrome or pregnancy induced hypertension.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov