Overview
Sponsor-declared trial summary
Infertility
To investigate if luteal phase support with a standard dose of vaginal progesterone increases the clinical pregnancy rates following mild ovarian stimulation with letrozole in infertile women undergoing IUI
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2026-03-09
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To investigate if luteal phase support with a standard dose of vaginal progesterone increases the clinical pregnancy rates following mild ovarian stimulation with letrozole in infertile women undergoing IUI
Conditions and MedDRA coding
Infertility
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | LLT | 10016398 | Female infertility | 10038604 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age 18-37 years
- Scheduled for intrauterine insemination with homologous or donor sperm
- Undergoing mild ovarian stimulation with letrozole
- Ability to provide written informed consent
Exclusion criteria 9
- Age > 37 years
- Anovulation due to hypogonadotropic hypogonadism
- Known hypersensitivity to progesterone or to hard fat listed as an excipient in the Summary of Product Characteristics (SmPC) for Cyclogest.
- Known or suspected progesterone-sensitive malignant tumours
- Porphyria
- Known missed abortion or ectopic pregnancy
- Active arterial or venous thromboembolism, severe thrombophlebitis, or a history of these conditions
- Severe hepatic dysfunction or liver disease
- Inability to speak or understand Danish sufficiently to comprehend oral and written study information
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Clinical pregnancy rate
Secondary endpoints 7
- Live birth rate
- Biochemical pregnancy rate
- Early pregnancy loss
- Fetal miscarriage
- Perinatal outcomes: preterm birth, birth weight, congenital malformation, perinatal mortality
- Obstetric outcomes: hypertensive disorders of pregnancy, gestational diabetes, postpartum hemorrhage and cesarean section
- Hormone levels measured on the day of insemination, mid-luteal phase and ovulation trigger (optional)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD6982224 · Product
- Active substance
- Progesterone
- Pharmaceutical form
- PESSARY
- Route of administration
- VAGINAL USE
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 44800 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- 16-11050
- MA holder
- GEDEON RICHTER PLC.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Sundvej 30
- City
- Horsens
- Postcode
- 8700
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Kirstine Kirkegaard
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Kirstine Kirkegaard
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 12 |
| Region Hovedstaden ORG-100003705
|
Herlev, Denmark | Laboratory analysis |
| Rigshospitalet ORG-100002431
|
Copenhagen Oe, Denmark | Laboratory analysis |
| Region Hovedstaden ORG-100003705
|
Hvidovre, Denmark | Laboratory analysis |
| Region Midtjylland ORG-100009397
|
Horsens, Denmark | Laboratory analysis |
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 690 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-524327-53-00 | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material brochure pixibog | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Habile personer | 1 |
| Subject information and informed consent form (for publication) | L1_SIS adults | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information leaflet dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cyclogest | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DK 2025-524327-53-00 | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-14 | Denmark | Acceptable 2026-03-03
|
2026-03-09 |