Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
600
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
- 14 Jun 2024 → 5 Sep 2025
- Decision date (initial)
- 2024-05-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-507630-25-00
- WHO UTN
- U1111-1293-5452
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 | 100 | 2 |
| Czechia | Ended | 100 | 3 |
| Denmark | Ended | 100 | 2 |
| Norway | Ended | 100 | 3 |
| Spain | Ended | 200 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
UZ Brussel
Center of Reproductive Medicine, Laarbeeklaan 101, 1090, Jette
Antwerp University Hospital
Center of Reproductive Medicine, Drie Eikenstraat 655, 2650, Edegem
Ivf Cube SE
Clinic for Assisted Reproduction, Evropska 423/178, 160 00, Prague
FertiCare SE
-, Radlicka 3185/1c, Smichov, Prague
Gynem s.r.o.
Gynem Fertility Clinic, Na Orechovce 576/7, Stresovice, Prague
Rigshospitalet
Fertility Department, Blegdamsvej 9, 2100, Copenhagen Oe
Hvidovre Hospital
Obstetrics and Gynecology, The Fertility Clinic, Kettegaard Alle 30, 2650, Hvidovre
Sykehuset Telemark HF
Fertilitetsavdelingen, Ulefossvegen 55, 3710, Skien
Medicus Trondheim AS
Gynaecology, Reproductive Medicine, Beddingen 8, 7042, Trondheim
Medicus Bergen AS
-, Bredalsmarken 15, 5006, Bergen
Ginefiv S.L.
Obstetrics and gynaecology, Calle De Zurbano 51, 28010, Madrid
Ivi Sevilla S.L.
Reproductive Medicine, Calle Americo Vespucio 19, Parque Cientifico Y Tecnologico Cartuja 93, Sevilla
Ivi Madrid S.L.
Reproductive Medicine, Avenida Talgo 68-70, 28023, Madrid
Ivi Valencia S.L.
Reproductive Medicine, Placa Policia Local 3, 46015, Valencia
Hospital Universitari Dexeus Grupo Quironsalud
Department of Gynecology and Obstetrics, Calle De Sabino Arana 5-19, 08028, Barcelona
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 | 2024-06-24 | 2024-09-10 | |||
| Czechia | 2024-06-14 | 2024-06-21 | |||
| Denmark | 2024-08-02 | 2024-08-14 | |||
| Norway | 2024-11-07 | 2024-11-13 | |||
| Spain | 2024-06-24 | 2024-07-05 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-02 | Denmark | Acceptable 2024-05-21
|
2024-05-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-05 | Denmark | Acceptable 2024-08-27
|
2024-08-27 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-30 | Acceptable 2024-08-27
|
2024-09-30 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-11-07 | Denmark | Acceptable 2024-08-27
|
2024-11-07 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-29 | Denmark | Acceptable 2025-04-25
|
2025-04-25 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-07-04 | Acceptable 2025-04-25
|
2025-07-04 |