Overview
Sponsor-declared trial summary
Infertility, diminished ovarian reserve.
The aim of the study is to examine the effects of low dose hCG priming for eight weeks in women with DOR undergoing IVF/ICSI. We want to retest the findings of our pilot study (Friis Wang et al. 2023), as an increase of 50% in number of oocytes retrieved is clinically relevant.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 10 Sep 2025 → ongoing
- Decision date (initial)
- 2025-06-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Danmarks Frie Forskningsfond · Gedeon Richter
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The aim of the study is to examine the effects of low dose hCG priming for eight weeks in women with DOR undergoing IVF/ICSI. We want to retest the findings of our pilot study (Friis Wang et al. 2023), as an increase of 50% in number of oocytes retrieved is clinically relevant.
Conditions and MedDRA coding
Infertility, diminished ovarian reserve.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Female, Age 18-40 (both inclusive), Regular menstrual cycle (23-35 days), 1.-5. IVF/ICSI cycle at inclusion, AMH < 6.29 pmol/L (Elecsys® AMH assay)
Exclusion criteria 1
- Uterine malformations or hydrosalpinx, Submucosal uterine myomas, Uterine polyps, Allergy to standard IVF/ICSI medication, Endometriosis stage III-IV, Preimplantation genetic testing, Testicular sperm aspiration/extraction, Known severe comorbidity
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The number of oocytes retrieved after hCG vs placebo priming
Secondary endpoints 1
- Antral follicle count, AMH, number of follicles, number of fertilized eggs, number of cleaved day 2 embryos, number of good and top quality day 2 embryos, number of blastocysts, cycle cancellation rate, Reproductive hormone levels, granulosa cell receptor expression, prenancy and live birth rates
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe
PRD333018 · Product
- Active substance
- Choriogonadotropin Alfa
- Substance synonyms
- FE 999302, CHORIOGONADOTROPHIN ALPHA
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 500 µl microlitre(s)
- Max total dose
- 10000 µl microlitre(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03GA08 — CHORIOGONADOTROPIN ALFA
- Marketing authorisation
- EU/1/00/165/007
- MA holder
- MERCK EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Only labeling has been performed as it is a double blinded trial. Labeling will be performed by 'Region Hovedstadens Apotek, Produktionen, Kliniske forsoeg’, which has manufacturing license and works according to EU GMP-guidelines.
Placebo 1
Natriumklorid 9 mg/ml (0,5 ml injektionsvæske)
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Kristine Løssl
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Kristine Løssl
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruiting | 80 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Denmark | 2025-09-10 |
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 2025-521234-28-00 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_General rights in CTR | 1 |
| Subject information and informed consent form (for publication) | L1_ICF hCG Priming RCT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS hCG Priming RCT | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ovitrelle | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ovitrelle DK | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DK 2025-521234-28-00 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-05 | Denmark | Acceptable 2025-05-16
|
2025-06-03 |