Pregnancy RelatedPhase 4LUMONCT05080569
Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment
A Phase 4 study testing Progesterone Vaginal Product in people with Pregnancy Related and Fertility Issues, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The LUMO study is a multicenter, randomized controlled trial that evaluates the effectivity of luteal phase support in MOH/IUI treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Fertility Issues, Luteal Phase Defect
- What is being tested?
- Progesterone Vaginal Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,008 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2023to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cycle irregularities
- Male factor infertility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht
Simone Broer, 088 755 75 25, s.l.broer-2@umcutrecht.nl
Broer
About this study
Official title: LUMO Study: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH
The LUMO study is a multicenter, randomized controlled trial that evaluates the effectivity of luteal phase support in MOH/IUI treatment.
Read the 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.
- Being tested
- Progesterone Vaginal Product, Placebo
- Keywords
- progesterone, Cost-effective, Intrauterine insemination, live birth, luteal support, ongoing pregnancy, ovulation induction, unexplained infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone Vaginal ProductDrug
Also called Utrogestan
3dd200mg
PlaceboDrug
3dd1 vaginal capsule
| Study group | Role | What they receive |
|---|---|---|
| MOH/IUI treatment with LPS | Experimental | (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 Receives: Drug: Progesterone Vaginal Product |
| MOH/IUI treatment with placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth
Pregnancy leading to Live birth within six months.
Measured: 6 months
Secondary outcomes (9)
Clinical pregnancy rate
Number and rate of patients that achieve a clinical pregnancy within six months
Measured: <6 months
Miscarriage rate
Number and rate of patients that experience miscarriage (gestation <16weeks) within six months
Measured: <6 months
Multiple pregnancy rate
Number of pregnancies with 2 or more fetuses
Measured: <6 months
Pregnancy complications
Pregnancies complicated by preterm labor (<37 weeks), loss of pregnancy (>16weeks), gestational diabetes, preeclampsia, HELLP syndrome or pregnancy induced hypertension.
Measured: 1 year
Perinatal outcomes
Stillbirth/Livebirth/Perinatal death, Gestational age at delivery, birthweight
Measured: <6 weeks
Side effects
Nausea, stomach ache, vaginal discharge, other (self reported) side effects
Measured: <1 year
Compliance to therapy
Use of medication as prescribed
Measured: 6 months
Added medication costs
Increae in total therapy costs due to the addition of Utrogestan (the treatment).
Measured: 1 year
Budget impact
Economic assessment that estimated financial consequences of adopting a new intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Mar 2023
- Primary completionDec 2025 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,008 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank JM Broekmans, UMC Utrecht
- Investigators
- Broekmans, Prof. Dr., Principal investigator, Professor Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080569
- Sponsor's protocol ID
- 2359660
- Acronym
- LUMO
- Status last verified
- Oct 2025
- First submitted
- 9 Aug 2021
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After finishing the project, data will not be shared publicly, but under restricted access, as the data is privacy sensitive. We publish the descriptive metadata in the data repository with a description of how a data request can be made (by sending an email to the corresponding author). If other researchers like to reuse our data, this can only be granted if the research question is in line with the original informed consent signed by the study participants. Every application therefore will be screened upon this requirement. If granted, a data usage and transfer agreement is signed by the receiving party. The specific data that will be shared with third parties after approval of the Principal Investigator, will be determined on a case-by case basis. Based on the specific research question, all raw data including the codebook and scripts of analysis in SPSS/R may be shared if considered of added value and with mutual trust and agreement in a Data usage agreement.
Publications
Preesman E, Drechsel K, Crommelin H, Broekmans F, Verpoest W, Broer S; LUMO Study Group. Does luteal phase support in MOH-IUI treatment improve cumulative live birth rates in couples with unexplained subfertility? Study protocol of the LUMO study: a centre, randomised, double-blind, controlled trial with cost-effectiveness analysis. BMJ Open. 2025 Nov 19;15(11):e111872. doi: 10.1136/bmjopen-2025-111872.
PubMed 41263858
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUMO Study: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH
- ClinicalTrials.gov ID
- NCT05080569
- Acronym / sponsor ID
- LUMO / 2359660
- Keywords
- progesterone, Cost-effective, Intrauterine insemination, live birth, luteal support, ongoing pregnancy, ovulation induction, unexplained infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,008 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| MOH/IUI treatment with LPS | Experimental | Drug: Progesterone Vaginal Product(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 |
| MOH/IUI treatment with placebo | Placebo comparator | Drug: PlaceboFemales 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Cycle irregularities
- Male factor infertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progesterone Vaginal ProductAlso: Utrogestan3dd200mg | Drug | MOH/IUI treatment with LPS |
| Placebo3dd1 vaginal capsule | Drug | MOH/IUI treatment with placebo |
Primary outcome
Live Birth
Time frame: 6 months
Pregnancy leading to Live birth within six months.
9 secondary outcomes
Clinical pregnancy rate
Time frame: <6 months
Miscarriage rate
Time frame: <6 months
Multiple pregnancy rate
Time frame: <6 months
Pregnancy complications
Time frame: 1 year
Perinatal outcomes
Time frame: <6 weeks
Side effects
Time frame: <1 year
Compliance to therapy
Time frame: 6 months
Added medication costs
Time frame: 1 year
Budget impact
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Derived from this study: PubMed 41263858Preesman E, Drechsel K, Crommelin H, Broekmans F, Verpoest W, Broer S; LUMO Study Group. Does luteal phase support in MOH-IUI treatment improve cumulative live birth rates in couples with unexplained subfertility? Study protocol of the LUMO study: a centre, randomised, double-blind, controlled trial with cost-effectiveness analysis. BMJ Open. 2025 Nov 19;15(11):e111872. doi: 10.1136/bmjopen-2025-111872.
- Individual participant dataSharing planned: Yes. After finishing the project, data will not be shared publicly, but under restricted access, as the data is privacy sensitive. We publish the descriptive metadata in the data repository with a description of how a data request can be made (by sending an email to the corresponding author). If other researchers like to reuse our data, this can only be granted if the research question is in line with the original informed consent signed by the study participants. Every application therefore will be screened upon this requirement. If granted, a data usage and transfer agreement is signed by the receiving party. The specific data that will be shared with third parties after approval of the Principal Investigator, will be determined on a case-by case basis. Based on the specific research question, all raw data including the codebook and scripts of analysis in SPSS/R may be shared if considered of added value and with mutual trust and agreement in a Data usage agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Broekmans, Prof. Dr. principal investigator
Professor Reproductive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progesterone Vaginal Product in people with Pregnancy Related and Fertility Issues, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone Broer, Dr. (088 755 75 25, s.l.broer-2@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05080569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.