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Does progesterone luteal phase support increase live birth rates in couples undergoing intra-uterine insemination with Mild Ovarian HyperStimulation (MOH/IUI treatment), and is this addition to the treatment cost-effective? (The LUMO study)
EU CTIS ID: 2022-501534-33-00
What this study is testing
To determine the clinical efficacy of the addition of LPS in MOH-IUI treatment (using FSH for mild ovarian stimulation), in terms of cumulative live birth rate improvement
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of Unexplained Subfertility, based on national guideline definitions (NVOG)
- Hunault* <30% (or ≥30%, after an expectant management period of at least 6 additional months). *Calculated prognosis for pregnancy leading to a live birth in the year ahead
- Female age 18-43 years
- Female BMI (body-mass index) <45 kg/m2
- Primary or secondary Subfertility, for at least a period of 1 year
- Regular menstrual cycles
You likely can't join if
- Uncorrected uterine factors, such as endometrial polyps or submucosal fibroids,
- Insufficient knowledge or understanding of the Dutch or English language and not willing or able to receive study information via a certified translator,
- Not able or willing to provide (written) informed consent
- Contraindications for vaginal progesterone, in particular: females with allergy to peanuts or soya.
See the full eligibility criteria
- Diagnosis of Unexplained Subfertility, based on national guideline definitions (NVOG)
- Hunault* <30% (or ≥30%, after an expectant management period of at least 6 additional months). *Calculated prognosis for pregnancy leading to a live birth in the year ahead
- Female age 18-43 years
- Female BMI (body-mass index) <45 kg/m2
- Primary or secondary Subfertility, for at least a period of 1 year
- Regular menstrual cycles
- Total mobile sperm count (TMC) >10 million
- First MOH-IUI cycle (with gonadotropins), with the intent to receive this treatment for at least six months.
- Uncorrected uterine factors, such as endometrial polyps or submucosal fibroids,
- Insufficient knowledge or understanding of the Dutch or English language and not willing or able to receive study information via a certified translator,
- Not able or willing to provide (written) informed consent
- Contraindications for vaginal progesterone, in particular: females with allergy to peanuts or soya.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.