Clinical trial • Phase IV • Other
Nafarelin for Infertility | Female infertility
Phase IV trial of Nafarelin for Infertility | Female infertility.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Infertility | Female infertility
- Trial Stage
- Phase IV
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 13-09-2024
- First CTIS Authorization Date
- 09-12-2024
Trial design
Randomised, comparator arm: decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable (triptorelin) — subcutaneous injection (comparator). test arm: synarel 200 microgramos solución para pulverización nasal (nafarelin) — nasal spray (test). specific dosing schedule for trigger administration not specified in the available record.-controlled Phase IV trial across 4 sites in Spain.
- Randomised
- Yes
- Comparator
- Comparator arm: Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable (triptorelin) — subcutaneous injection (comparator). Test arm: Synarel 200 microgramos solución para pulverización nasal (nafarelin) — nasal spray (test). Specific dosing schedule for trigger administration not specified in the available record.
- Target Sample Size
- 134
Eligibility
Recruits 134 No vulnerable population selected; participants are adult females (Age 18 – 35). No details on consent/assent handling are provided in the available record..
- Vulnerable Population
- No vulnerable population selected; participants are adult females (Age 18 – 35). No details on consent/assent handling are provided in the available record.
Inclusion criteria
- {"criterion_text":"- Age 18 – 35\n- Oocyte donor\n- Undergoing a progesterone-primed ovarian stimulation cycle (PPOS) with any commercially available gonadotropin preparation(s)\n- BMI 18 – 30 kg/m2\n- ≥10 follicles of ≥14mm average diameter on the last ultrasound prior to trigger administration"}
Exclusion criteria
- {"criterion_text":"- Allergy or hypersensitivity to either nafarelin or triptorelin\n- Hypopituitarism\n- Known pituitary tumour\n- Contraindication to intranasal medication administration\n- Previous poor response to agonist trigger"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The number of MII oocytes retrieved.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Total number of oocytes collected\n- Ovarian Hyperstimulation Syndrome\n- Other side effects/adverse effects\n- Cost\n- Serum LH and FSH levels 12 hours after trigger\n- Serum LH, FSH and progesterone levels at the time of oocyte collection\n- Participant reported pain, ease of use and medication preference","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 134
- Recruitment Window Months
- 12
- Consent Approach
- Informed consent is required from participants who are adults (Age 18–35). A subject information and informed consent form document is listed (L1_HIPCI_INFORM_ES) but the content and languages of the consent form are not provided in the available record. No assent process for minors is applicable (minors are excluded).
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 134
Spain
- Earliest CTIS Part Ii Submission Date
- 18-11-2024
- Latest Decision Or Authorization Date
- 09-12-2024
- Processing Time Days
- 21
- Number Of Sites
- 4
- Number Of Participants
- 134
Sites
- Site Name
- Dexeus Mujer Reus
- Department Name
- Department of Reproductive Medicine
- Principal Investigator Name
- Josep Gonzalo
- Principal Investigator Email
- josgon@dexeus.com
- Contact Person Name
- Josep Gonzalo
- Contact Person Email
- josgon@dexeus.com
- Site Name
- Hospital Universitari General De Catalunya
- Department Name
- Department of Reproductive Medicine
- Principal Investigator Name
- Silvia Grau
- Principal Investigator Email
- silgra@dexeus.com
- Contact Person Name
- Silvia Grau
- Contact Person Email
- silgra@dexeus.com
- Site Name
- Hospital Universitari Dexeus Grupo Quironsalud
- Department Name
- Department of Reproductive Medicine
- Principal Investigator Name
- Nikolaos Polyzos
- Principal Investigator Email
- nikpol@dexeus.com
- Contact Person Name
- Nikolaos Polyzos
- Contact Person Email
- nikpol@dexeus.com
- Site Name
- Hospital Quironsalud Del Valles
- Department Name
- Department of Reproductive Medicine
- Principal Investigator Name
- Silvia Grau
- Principal Investigator Email
- silgra@dexeus.com
- Contact Person Name
- Silvia Grau
- Contact Person Email
- silgra@dexeus.com
Sponsor
Primary sponsor
- Full Name
- Santiago Dexeus Font Fundacio Privada
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Synarel 200 microgramos solución para pulverización nasal
- Active Substance
- Nafarelin
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- NASAL SPRAY
- Route
- Nasal spray
- Authorisation Status
- Marketing authorisation 60.079 (Spain)
- Starting Dose
- 200 µg (product labelled strength)
- Maximum Dose
- 800 µg
- Investigational Product Name
- Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable
- Active Substance
- Triptorelin
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- Subcutaneous injection
- Authorisation Status
- Marketing authorisation 62.431 (Spain)
- Starting Dose
- 0.1 mg
- Maximum Dose
- 200 µg
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