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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Medical Center Utrecht

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]

Trial duration

6 Mar 2023 → ongoing

Decision date (initial)

2023-01-31

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

ZonMW · Besins Healthcare

External identifiers

EU CT number

2022-501534-33-00

WHO UTN

U1111-1280-9461

ClinicalTrials.gov

NCT05080569

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

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

Secondary objectives 2

1. To determine the total budget impact of the addition of LPS in MOH-IUI treatment, in terms of reduction in total budget spent on infertility care in this specific patient group of unexplained infertility with low prognosis for spontaneous pregnancy.
2. To determine the safety and feasibility of LPS in MOH-IUI treatment, in terms of side effects, effects on quality-of-life measures, and pregnancy and neonatal outcome measures

Conditions and MedDRA coding

Unexplained Subfertility, infertility

Study design 1 period

Regulatory references

Plan to share IPD

No

IPD plan description

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). In the event that 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 Principle Investigator, will be determined on a case-bycase 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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Diagnosis of Unexplained Subfertility, based on national guideline definitions (NVOG)
2. 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
3. Female age 18-43 years
4. Female BMI (body-mass index) <45 kg/m2
5. Primary or secondary Subfertility, for at least a period of 1 year
6. Regular menstrual cycles
7. Total mobile sperm count (TMC) >10 million
8. First MOH-IUI cycle (with gonadotropins), with the intent to receive this treatment for at least six months.

Exclusion criteria 4

1. Uncorrected uterine factors, such as endometrial polyps or submucosal fibroids,
2. Insufficient knowledge or understanding of the Dutch or English language and not willing or able to receive study information via a certified translator,
3. Not able or willing to provide (written) informed consent
4. Contraindications for vaginal progesterone, in particular: females with allergy to peanuts or soya.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Pregnancy occurring within 6 months after randomization, leading to Live birth

Secondary endpoints 8

1. Clinical pregnancy, ongoing pregnancy, biochemical pregnancy loss and miscarriage rates within 6 months after randomisation.
2. For each participant, number of MOH-IUI cycles initiated, completed and cancelled are evaluated within 6 months after randomisation.
3. Of all achieved (ongoing) pregnancies occurring within 6 months after randomization (including spontaneous pregnancies) the following outcomes are assessed; multiple pregnancy rate, time to pregnancy, pregnancy complications, perinatal outcomes, type of delivery and outcomes
4. Side effects and compliance to therapy assessed during treatment using a medication dairy and a questionnaire, send out 6 months after randomization.
5. Quality of life assessed at time of randomization, and 6 and 18 months after randomization, using the FertiQoL questionnaire
6. Progression to IVF/ICSI within six months after randomization
7. Use of ART and (ongoing) pregnancy achieved after the six-month study period and within 12 months follow up.
8. Budget impact, Cost-effectiveness analyses using live birth rates, costs and quality of life.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Medical Center Utrecht

Sponsor organisation

University Medical Center Utrecht

Address

Heidelberglaan 100

City

Utrecht

Postcode

3584 CX

Country

Netherlands

Scientific contact point

Organisation

University Medical Center Utrecht

Contact name

Prof Dr. FJM Broekmans

Public contact point

Organisation

University Medical Center Utrecht

Contact name

LUMO study group

Locations

1 EU/EEA country · 33 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications