Continuing ovulation induction with letrozole versus switching to gonadotropins in women with polycystic ovary syndrome (MOVIN-II study)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC Stichting

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], Health Care [N] - Environment and Public Health [N06], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Health Care [N] - Health Care Economics and Organizations [N03]

Trial duration

1 Aug 2025 → ongoing

Decision date (initial)

2025-05-30

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

ZonMW

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To determine the clinical efficacy of continuing ovulation induction with letrozole versus switching to ovarian stimulation with gonadotropins, in terms of cumulative live birth rate improvement

Secondary objectives 4

1. To determine the safety and feasibility of continuing ovulation induction with letrozole versus switching to ovarian stimulation with gonadotropins, in terms of side-effects, pregnancy and neonatal outcomes
2. To determine the impact of continuing ovulation induction with letrozole versus switching to ovarian stimulation with gonadotropins on quality-of-life and mental health measures
3. To determine the cost-effectiveness and budget impact of continuing ovulation induction with letrozole versus switching to ovarian stimulation with gonadotropins, in terms of reduction in total budget spent on infertility care in women with polycystic ovary syndrome that ovulate on letrozole but did not yet conceive after 6 ovulatory cycles.
4. To determine the environmental impact of continuing ovulation induction with letrozole versus switching to ovarian stimulation with gonadotropins.

Conditions and MedDRA coding

Polycystic ovary syndrome (PCOS)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Couples or single women with childwish
2. Diagnosed PCOS (normogonadotropic anovulation with hyperandrogenaemia (diagnosed clinically by the presence of excessive acne, androgenic alopecia, or hirsutism or by elevated serum levels of total, bioavailable, or free testosterone or dehydroepiandrosterone sulfate) or polycystic ovaries on ultrasound)
3. Age 18-42 years
4. Ovulatory for six cycles on letrozole treatment

Exclusion criteria 6

1. Contra-indication to letrozole
2. Total motile sperm count (VCM) < 3 million
3. Known bilateral fallopian tube pathology or occlusion (patients with at least one patent fallopian tube are eligible)
4. Major medical morbidity (e.g. poorly controlled Type I or Type II diabetes, known liver disease or dysfunction based on serum liver enzyme testing, renal disease or abnormal serum renal function)
5. Inability to give informed consent
6. Additional contra-indications reported in the SPC are: Hypersensitivity to the active substance, during pregnancy and breast feeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Pregnancy within 8 months after randomization, leading to a live birth

Secondary endpoints 6

1. Clinical pregnancy, ongoing pregnancy, biochemical pregnancy loss and miscarriage rates within 8 months after randomisation
2. For each participant, the number of treatment cycles initiated, completed and cancelled are evaluated within 8 months after randomisation
3. Of all achieved (ongoing) pregnancies occurring within 8 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, compliance and smoking behavior during treatment assessed through telephone appointment and questionnaires sent out at 3 months and 8 months after randomisation.
5. Quality of life and mental health assessed at time of randomization, and at 3 months and 8 months after randomization, using the PCOS-QoL questionnaire and the HADS questionnaire
6. Budget impact and cost-effectiveness analyses using live birth rates

Investigational products

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

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC Stichting

Sponsor organisation

Amsterdam UMC Stichting

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC Stichting

Contact name

Dr. M. van Wely

Public contact point

Organisation

Amsterdam UMC Stichting

Contact name

Dr. M. van Wely

Locations

1 EU/EEA country · 31 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 14 files

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

Application history

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