LUMO Study: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH
Who is this study for? Patients with Luteal Phase Defect, Infertility
What treatments are being studied? Progesterone Vaginal Product
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The LUMO study is a multicenter, randomized controlled trial that evaluates the effectivity of luteal phase support in MOH/IUI treatment.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Netherlands
UMC Utrecht
RECRUITING
Utrecht
Contact Information
Primary
Simone Broer, Dr.
s.l.broer-2@umcutrecht.nl
088 755 75 25
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2027-07
Participants
Target number of participants: 1008
Treatments
Experimental: MOH/IUI treatment with LPS
(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
Placebo_comparator: MOH/IUI treatment with placebo
Females will receive regular MOH/IUI treatment. The female cycle is mildly stimulated and monitored until the desired amount of ripe follicles is achieved. In the absence of other reasons to cancel the treatment, ovulation is triggered and subsequently pre-washed semen is inseminated into the uterus.~Females assigned to the placebo group start placebo, applying 3dd1 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
Related Therapeutic Areas
Sponsors
Leads: UMC Utrecht