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)

Phase 1

Recruiting

Conditions: nexplained Subfertility, infertility
MedDRA version: 20.1Level: LLTClassification code: 10016399Term: Female infertility (primary) Class: 10038604
MedDRA version: 20.1Level: LLTClassification code: 10021940Term: Infertility female of unspecified origin Class: 10038604
MedDRA version: 20.1Level: LLTClassification code: 10016398Term: Female infertility Class: 10038604
MedDRA version: 20.0Level: LLTClassification code: 10042391Term: Subfertility Class: 10038604
MedDRA version: 20.0Level: LLTClassification code: 10042392Term: Subfertility (female) Class: 10038604
MedDRA version: 21.1Level: LLTClassification code: 10039843Term: Secondary infertility (female) Class: 10038604
MedDRA version: 21.0Level: PTClassification code: 10021926Term: Infertility Class: 100000004872
MedDRA version: 20.0Level: PTClassification code: 10021928Term: Infertility female Class: 100000004872
MedDRA version: 20.0Level: PTClassification code: 10062021Term: Infertility tests normal Class: 100000004848

Registration Number: CTIS2022-501534-33-00

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1008

Inclusion 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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Objective: 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., 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;Primary end point(s): Pregnancy occurring within 6 months after randomization, leading to Live birth

Secondary Outcome Measures