Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
201
Countries
5
Sites
15
Infertility in women undergoing assisted reproductive technologies (ART)
Key facts
- Sponsor
- Ferring Pharmaceuticals A/S
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 16 Jul 2024 → 5 Sep 2025
- Decision date (initial)
- 2024-06-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508149-42-00
- WHO UTN
- U1111-1297-6494
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Infertility in women undergoing assisted reproductive technologies (ART)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ferring Pharmaceuticals A/S
- Sponsor organisation
- Ferring Pharmaceuticals A/S
- Address
- Amager Strandvej 405
- City
- Kastrup
- Postcode
- 2770
- Country
- Denmark
Scientific contact point
- Organisation
- Ferring Pharmaceuticals A/S
- Contact name
- Sarah Grover
Public contact point
- Organisation
- Ferring Pharmaceuticals A/S
- Contact name
- Clinical and Translational Sciences
Locations
5 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 27 | 2 |
| Czechia | Ended | 40 | 3 |
| Denmark | Ended | 27 | 2 |
| Norway | Ended | 39 | 3 |
| Spain | Ended | 68 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Antwerp University Hospital
Center for Reproductive Medicine, Drie Eikenstraat 655, 2650, Edegem
UZ Brussel
Center for Reproductive Medicine, Laarbeeklaan 101, 1090, Jette
FertiCare SE
-, Radlicka 3185/1c, Smichov, Prague
Ivf Cube SE
Clinic for Assisted Reproduction, Evropska 423/178, 160 00, Prague
Gynem s.r.o.
Gynem Fertility Clinic, Na Orechovce 576/7, Stresovice, Prague
Hvidovre Hospital
The Fertility Clinic, Kettegaard Alle 30, 2650, Hvidovre
Rigshospitalet
Fertility Department, Blegdamsvej 9, 2100, Copenhagen Oe
Medicus Bergen AS
-, Bredalsmarken 15, 5006, Bergen
Medicus Trondheim AS
Gynecology, Reproductive Medicine and Clinical Trials, Beddingen 8, 7042, Trondheim
Sykehuset Telemark Hf
Fertilitetsavdelingen Sør, Aalsgate 41, 3913, Porsgrunn
Hospital Universitari Dexeus Grupo Quironsalud
Department of Gynecology and Obstetrics, Calle De Sabino Arana 5-19, 08028, Barcelona
Ivi Sevilla S.L.
Reproductive Medicine, Calle Americo Vespucio 19, Parque Cientifico Y Tecnologico Cartuja 93, Sevilla
Ivi Valencia S.L.
Reproductive Medicine, Placa Policia Local 3, 46015, Valencia
Ivi Madrid S.L.
Reproductive Medicine, Avenida Talgo 68-70, 28023, Madrid
Ginefiv S.L.
Obstetrics and gynaecology, Calle De Zurbano 51, 28010, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2024-10-15 | ||||
| Czechia | 2024-07-29 | 2024-08-12 | |||
| Denmark | 2024-09-26 | 2024-10-17 | |||
| Norway | 2024-11-14 | 2024-12-09 | |||
| Spain | 2024-07-16 | 2024-07-17 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-26 | Denmark | Acceptable with conditions 2024-06-17
|
2024-06-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-10 | Denmark | Acceptable 2024-08-27
|
2024-09-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-14 | Acceptable 2024-08-27
|
2024-10-14 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-29 | Denmark | Acceptable 2025-04-25
|
2025-04-25 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-04 | Acceptable 2025-04-25
|
2025-07-04 |