Fertility Issues, Infertility Unexplained, Luteal Phase Defect, Pregnancy Related
Conditions
Keywords
progesterone, Cost-effective, Intrauterine insemination, live birth, luteal support, ongoing pregnancy, ovulation induction, unexplained infertility
Brief summary
The LUMO study is a multicenter, randomized controlled trial that evaluates the effectivity of luteal phase support in MOH/IUI treatment.
Detailed description
Participating sites consist of academic and non-academic hospitals and fertility clinics in The Netherlands. There are two treatment arms (MOH/IUI treatment with LPS vs MOH/IUI treatment with placebo) with a non-blinded superiority design. Participants are randomly distributed across both treatment arms for the entire study-period (six months, non-crossover). Eligibility criteria are: 1) couples starting IUI with Mild Ovarian HyperStimulation (MOH), with the intend to receive this treatment for at least six months. 2) Indication for MOH/IUI treatment is in accordance with current (dutch) NVOG guidelines; Diagnosis of unexplained (primary or secondary) infertility with Hunault \<30% (or \>30%, after an expectant management period of at least 6 additional months). Total mobile sperm count (VCM) \>10 million. 3) Females aged \>18 years with regular menstrual cycle. (Mild) Ovarian stimulating treatment and insemination are according to regular treatment protocol. Females assigned to the treatment group start LPS, applying 3dd200mg Utrogestan in vaginal capsules, on the day of IUI. Treatment is continued until the onset of menstruation, a negative pregnancy test, miscarriage or confirmed vital intra-uterine pregnancy at 7 weeks gestation. Main outcome is pregnancy within 6 months of treatment, leading to Live birth. Secondary outcomes are; Clinical pregnancy rate. Miscarriage rate. Multiple pregnancy rate. Pregnancy complications. Perinatal outcomes. Side effects and compliance to therapy. Added Medication Costs. Budget impact. The analyses will include a cost-effectiveness analysis.
Interventions
3dd200mg
DRUGPlacebo
3dd1 vaginal capsule
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blinded superiority design
Intervention model description
The LUMO study is a multicenter, randomized, placebo-controlled trial with cost-effectiveness analysis. Participating sites consist of academic and non-academic hospitals and fertility clinics. There are two treatment arms (MOH/IUI treatment with LPS vs MOH/IUI treatment with placebo) with a non-blinded superiority design. Participants are randomly distributed across both treatment arms for the entire study-period (six months, non-crossover).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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% (or \>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 cirteria: * Cycle irregularities * Male factor infertility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live Birth | 6 months | Pregnancy leading to Live birth within six months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Miscarriage rate | <6 months | Number and rate of patients that experience miscarriage (gestation \<16weeks) within six months |
| Multiple pregnancy rate | <6 months | Number of pregnancies with 2 or more fetuses |
| Pregnancy complications | 1 year | Pregnancies complicated by preterm labor (\<37 weeks), loss of pregnancy (\>16weeks), gestational diabetes, preeclampsia, HELLP syndrome or pregnancy induced hypertension. |
| Perinatal outcomes | <6 weeks | Stillbirth/Livebirth/Perinatal death, Gestational age at delivery, birthweight |
| Clinical pregnancy rate | <6 months | Number and rate of patients that achieve a clinical pregnancy within six months |
| Compliance to therapy | 6 months | Use of medication as prescribed |
| Added medication costs | 1 year | Increae in total therapy costs due to the addition of Utrogestan (the treatment). |
| Budget impact | 1 year | Economic assessment that estimated financial consequences of adopting a new intervention |
| Side effects | <1 year | Nausea, stomach ache, vaginal discharge, other (self reported) side effects |
Countries
Netherlands
Contacts
Primary ContactSimone Broer, Dr.
Outcome results
None listed