Clinical trial • Other
CHORIOGONADOTROPIN ALFA for Infertility | Diminished ovarian reserve
Clinical trial of CHORIOGONADOTROPIN ALFA for Infertility | Diminished ovarian reserve.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Infertility | Diminished ovarian reserve
- Drug Modality
- Peptide/protein/enzyme | Other
Key dates
- Initial CTIS Submission Date
- 05-03-2025
- First CTIS Authorization Date
- 03-06-2025
Trial design
Randomised, placebo: natriumklorid 9 mg/ml (0,5 ml injektionsvæske); test: ovitrelle 250 micrograms/0.5 ml solution for injection in pre-filled syringe. dose/schedule not specified in the ctis record.-controlled trial across 4 sites in Denmark.
- Randomised
- Yes
- Comparator
- Placebo: Natriumklorid 9 mg/ml (0,5 ml injektionsvæske); Test: Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe. Dose/schedule not specified in the CTIS record.
- Target Sample Size
- 80
- Trial Duration For Participant
- 56
Eligibility
Recruits 80 No vulnerable population selected; participants are adult women aged 18-40. Informed consent is required; subject information and informed consent forms are provided (documents L1_SIS hCG Priming RCT, L1_ICF hCG Priming RCT). No assent procedures described..
- Vulnerable Population
- No vulnerable population selected; participants are adult women aged 18-40. Informed consent is required; subject information and informed consent forms are provided (documents L1_SIS hCG Priming RCT, L1_ICF hCG Priming RCT). No assent procedures described.
Inclusion criteria
- {"criterion_text":"- Female"}
- {"criterion_text":"- Age 18-40 (both inclusive)"}
- {"criterion_text":"- Regular menstrual cycle (23-35 days)"}
- {"criterion_text":"- 1.-5. IVF/ICSI cycle at inclusion"}
- {"criterion_text":"- AMH < 6.29 pmol/L (Elecsys® AMH assay)"}
Exclusion criteria
- {"criterion_text":"- Uterine malformations or hydrosalpinx"}
- {"criterion_text":"- Submucosal uterine myomas"}
- {"criterion_text":"- Uterine polyps"}
- {"criterion_text":"- Allergy to standard IVF/ICSI medication"}
- {"criterion_text":"- Endometriosis stage III-IV"}
- {"criterion_text":"- Preimplantation genetic testing"}
- {"criterion_text":"- Testicular sperm aspiration/extraction"}
- {"criterion_text":"- Known severe comorbidity"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The number of oocytes retrieved after hCG vs placebo priming","definition_or_measurement_approach":"Number of oocytes retrieved per participant at oocyte retrieval (count of oocytes retrieved following stimulation/priming)."}
Secondary endpoints
- {"endpoint_text":"- Antral follicle count","definition_or_measurement_approach":"Measured by ultrasound count of antral follicles."}
- {"endpoint_text":"- AMH","definition_or_measurement_approach":"Measured by biochemical assay (AMH level, Elecsys® AMH assay referenced)."}
- {"endpoint_text":"- number of follicles","definition_or_measurement_approach":"Count of follicles by ultrasound."}
- {"endpoint_text":"- number of fertilized eggs","definition_or_measurement_approach":"Count of fertilized oocytes following insemination/ICSI."}
- {"endpoint_text":"- number of cleaved day 2 embryos","definition_or_measurement_approach":"Count of embryos with cleavage on day 2 after fertilization."}
- {"endpoint_text":"- number of good and top quality day 2 embryos","definition_or_measurement_approach":"Embryo quality assessment on day 2 using local morphology grading."}
- {"endpoint_text":"- number of blastocysts","definition_or_measurement_approach":"Count of blastocyst-stage embryos."}
- {"endpoint_text":"- cycle cancellation rate","definition_or_measurement_approach":"Proportion of cycles cancelled prior to oocyte retrieval."}
- {"endpoint_text":"- Reproductive hormone levels","definition_or_measurement_approach":"Measured by relevant hormone assays (e.g., estradiol, progesterone, others) as per protocol."}
- {"endpoint_text":"- granulosa cell receptor expression","definition_or_measurement_approach":"Assessment of receptor expression in granulosa cells (laboratory molecular/biochemical assays)."}
- {"endpoint_text":"- prenancy and live birth rates","definition_or_measurement_approach":"Pregnancy and live birth outcomes measured per cycle/participant (clinical pregnancy and live birth counts)."}
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 71
- Consent Approach
- Informed consent documented via subject information and ICF documents (L1_SIS hCG Priming RCT, L1_ICF hCG Priming RCT). Consent provided by the adult participant (female, age 18-40). No assent procedures described. Languages of documents not specified in CTIS record. Contact for consent queries: Kristine Løssl (kristine.loessl@regionh.dk).
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 80
Denmark
- Earliest CTIS Part Ii Submission Date
- 22-04-2025
- Latest Decision Or Authorization Date
- 03-06-2025
- Processing Time Days
- 42
- Number Of Sites
- 4
- Number Of Participants
- 80
Sites
- Site Name
- Odense University Hospital
- Department Name
- Afdeling for Gynækologi og Obstetrik
- Principal Investigator Name
- Mette Petri Lauritsen
- Principal Investigator Email
- Mette.Petri.Lauritsen@rsyd.dk
- Contact Person Name
- Mette Petri Lauritsen
- Contact Person Email
- Mette.Petri.Lauritsen@rsyd.dk
- Site Name
- Hvidovre Hospital
- Department Name
- Fertilitetsklinikken
- Principal Investigator Name
- Lea Langhoff Thuesen
- Principal Investigator Email
- lea.thuesen@regionh.dk
- Contact Person Name
- Lea Langhoff Thuesen
- Contact Person Email
- lea.thuesen@regionh.dk
- Site Name
- Herlev Hospital
- Department Name
- Afdelingen for Kvindesygdomme, Graviditet og Fødsler
- Principal Investigator Name
- Pernille Fog Svendsen
- Principal Investigator Email
- pernille.fog.svendsen@regionh.dk
- Contact Person Name
- Pernille Fog Svendsen
- Contact Person Email
- pernille.fog.svendsen@regionh.dk
- Site Name
- Rigshospitalet
- Department Name
- Fertilitetsklinikken, Afdeling for Gynækologi, Fertilitet og Fødsler
- Principal Investigator Name
- Kristine Løssl
- Principal Investigator Email
- kristine.loessl@regionh.dk
- Contact Person Name
- Kristine Løssl
- Contact Person Email
- kristine.loessl@regionh.dk
Sponsor
Primary sponsor
- Full Name
- Rigshospitalet
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe
- Active Substance
- CHORIOGONADOTROPIN ALFA
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised - marketing authorisation EU/1/00/165/007
- Maximum Dose
- maxDailyDoseAmount 500 µl; maxTotalDoseAmount 10000 µl (as reported in CTIS record)
- Investigational Product Name
- Natriumklorid 9 mg/ml (0,5 ml injektionsvæske)
- Modality
- Other
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