Clinical trial • Phase IV • Other
FOLLITROPIN ALFA for Female infertility | Low ovarian sensitivity (POSEIDON group 2)
Phase IV trial of FOLLITROPIN ALFA for Female infertility | Low ovarian sensitivity (POSEIDON group 2).
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Female infertility | Low ovarian sensitivity (POSEIDON group 2)
- Trial Stage
- Phase IV
- Drug Modality
- Peptide/protein/enzyme | Small molecule
Key dates
- Initial CTIS Submission Date
- 13-09-2024
- First CTIS Authorization Date
- 23-09-2024
Trial design
Randomised, pergoveris (rhfsh + rhlh combination) versus gonal-f (rhfsh alone). trial compares 300 iu rhfsh + 150 iu rhlh (pergoveris) versus 300 iu rhfsh alone (gonal-f) in a gnrh antagonist protocol. auxiliary/support medications listed include cetrotide 0.25 mg (subcutaneous), crinone 8% vaginal gel (progesterone), and ovitrelle 250 micrograms (trigger).-controlled Phase IV trial across 4 sites in Spain.
- Randomised
- Yes
- Comparator
- Pergoveris (rhFSH + rhLH combination) versus Gonal-F (rhFSH alone). Trial compares 300 IU rhFSH + 150 IU rhLH (Pergoveris) versus 300 IU rhFSH alone (Gonal-F) in a GnRH antagonist protocol. Auxiliary/support medications listed include Cetrotide 0.25 mg (subcutaneous), Crinone 8% vaginal gel (progesterone), and Ovitrelle 250 micrograms (trigger).
- Target Sample Size
- 120
Eligibility
Recruits 120 No vulnerable populations selected; participants are adult women (Age: ≥35 ≤40) who must be able and willing to sign the Patient Consent Form. Informed consent is required from the participant herself; consent forms are provided (English and Spanish). No assent procedures are specified..
- Pregnancy Exclusion
- Recent history of severe disease requiring regular treatment (Clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment and patients with any contraindication to pregnancy).
- Vulnerable Population
- No vulnerable populations selected; participants are adult women (Age: ≥35 ≤40) who must be able and willing to sign the Patient Consent Form. Informed consent is required from the participant herself; consent forms are provided (English and Spanish). No assent procedures are specified.
Inclusion criteria
- {"criterion_text":"- POSEIDON group 2 patients\n- Able and willing to sign the Patient Consent Form and adhere to study visitation schedule.\n- Age: ≥ 35 years ≤40 years old.\n- antral Follicle Count (AFC) ≥5 and /or antimullerian hormone (AMH) ≥1.2 ng/mL.\n- <4 or 4-9 oocytes retrieved in a previous IVF/ICSI cycle with a starting dose of ≤225IU with any gonadotropin under a GnRH antagonist protocol.\n- Up to 3 previous ovarian stimulation cycles with a starting dose of ≤225IU in which dose adjustments during stimulation did not exceed 300IU.\n- Ovarian stimulation for IVF/ICSI"}
Exclusion criteria
- {"criterion_text":"- Poor ovarian responders according to the Bologna criteria.\n- Contraindications for the use of medicine used for ovarian stimulation (gonadotropins, GnRH antagonist, progesterone vaginal gel)\n- Recent history of severe disease requiring regular treatment (Clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment and patients with any contraindication to pregnancy).\n- PGT-a (Preimplantation Genetic Testing for Aneuploidies).\n- TESA or TESE (Testicular Sperm Aspiration or Testicular Sperm Extraction)\n- PCOS patients according to the Rotterdam criteria.\n- AFC>20.\n- Age >40 or <35 years old.\n- Women with >10 oocytes retrieved in a previous IVF/ICSI cycle with 150-225 IU starting dose.\n- Women who required dose adjustments during stimulation >300 IU with any gonadotropin in their previous cycle\n- Uterine abnormalities.\n- Recent history of any current untreated endocrine abnormality.\n- Unilateral or bilateral hydrosalpinx (visible on USS, unless clipped)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary efficacy endpoint is serum progesterone levels as well as P4/E2 ratio on the day of ovulation triggering. The primary efficacy endpoint is related to the primary trial objective.","definition_or_measurement_approach":"Serum progesterone levels and P4/E2 ratio measured on the day of ovulation triggering."}
Secondary endpoints
- {"endpoint_text":"- Serum levels of estradiol, FSH, Testosterone and LH levels and P4/E2 ratio on days 1, 6, 8, 10 and the final day of oocyte maturation.","definition_or_measurement_approach":"Serum levels measured on days 1, 6, 8, 10 and the final day of oocyte maturation; P4/E2 ratio measured at these timepoints."}
- {"endpoint_text":"- Progesterone-to-follicle Index (PFI) on the day of ovulation triggering","definition_or_measurement_approach":"PFI calculated on the day of ovulation triggering."}
- {"endpoint_text":"- Number of oocytes.","definition_or_measurement_approach":"Count of oocytes retrieved per participant."}
- {"endpoint_text":"- Number of patients with optimal number of oocytes retrieved (≥10 oocytes).","definition_or_measurement_approach":"Proportion of patients with ≥10 oocytes retrieved."}
- {"endpoint_text":"- Number of embryos.","definition_or_measurement_approach":"Count of embryos generated per participant."}
- {"endpoint_text":"- Good-quality embryos.","definition_or_measurement_approach":"Number or proportion of embryos meeting predefined 'good-quality' criteria (as per protocol)."}
- {"endpoint_text":"- Number of blastocysts.","definition_or_measurement_approach":"Count of blastocysts per participant."}
- {"endpoint_text":"- Clinical pregnancy defined as the presence of intrauterine gestational sac at 6-7 weeks of gestation.","definition_or_measurement_approach":"Clinical pregnancy assessed by ultrasound detection of intrauterine gestational sac at 6-7 weeks."}
- {"endpoint_text":"- Ongoing pregnancy defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 8-9 weeks of gestation.","definition_or_measurement_approach":"Ongoing pregnancy assessed by ultrasound detection of gestational sac with embryonic pole cardiac activity at 8-9 weeks."}
Recruitment
- Planned Sample Size
- 120
- Recruitment Window Months
- 72
- Consent Approach
- Participants must be able and willing to sign the Patient Consent Form (informed consent provided by the participant). Consent documentation is available in English and Spanish (documents L1_HIPCI PEARL EN and L1_HIPCI PEARL ESP). No assent procedures are specified.
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 120
Spain
- Earliest CTIS Part Ii Submission Date
- 24-04-2024
- Latest Decision Or Authorization Date
- 23-09-2024
- Processing Time Days
- 152
- Number Of Sites
- 4
- Number Of Participants
- 120
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- institut Clínic de Ginecologia, obstetricia i neonatologia (ICGON)
- Contact Person Name
- Dolors Manau
- Contact Person Email
- dmanau@clinic.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Unidad de Reproducción Humana
- Contact Person Name
- Laura De la Fuente
- Contact Person Email
- lauradlfb@gmail.com
- Site Name
- Hospital Universitari Dexeus Grupo Quironsalud
- Department Name
- Department of Reproductive Medicine
- Contact Person Name
- Nikolaos Polyzos
- Contact Person Email
- nikpol@dexeus.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Unidad de Reproducción Asistida Servicio de Obstetricia y Ginecologia
- Contact Person Name
- Antonio Gosalvez
- Contact Person Email
- antonio.gosalvez@gmail.com
Sponsor
Primary sponsor
- Full Name
- Santiago Dexeus Fontacio Privada
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- GONAL-f 900 IU/1.44 mL solution for injection in pre-filled pen
- Active Substance
- FOLLITROPIN ALFA
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 300 IU (rhFSH) [as per trial arm]
- Dose Levels
- maxDailyDoseAmount: 300 IU; maxTotalDoseAmount: 4500 IU
- Maximum Dose
- 300 IU (max daily)
- Investigational Product Name
- Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen
- Active Substance
- FOLLITROPIN ALFA, LUTROPIN ALFA
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 300 IU rhFSH + 150 IU rhLH (as per trial comparator arm)
- Dose Levels
- maxDailyDoseAmount: 300 IU; maxTotalDoseAmount: 4500 IU
- Maximum Dose
- 300 IU (max daily rhFSH component)
- Investigational Product Name
- Cetrotide 0.25 mg powder and solvent for solution for injection
- Active Substance
- CETRORELIX
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 0.25 mg (product name / typical dose)
- Dose Levels
- maxDailyDoseAmount: 0.25 mg; maxTotalDoseAmount: 2.25 mg
- Maximum Dose
- 0.25 mg (max daily)
- Investigational Product Name
- Crinone 8% gel vaginal
- Active Substance
- PROGESTERONE
- Modality
- Small molecule
- Routes Of Administration
- VAGINAL USE
- Route
- Vaginal
- Authorisation Status
- Authorised
- Dose Levels
- maxDailyDoseAmount: 90 mg; maxTotalDoseAmount: 3780 mg
- Maximum Dose
- 90 mg (max daily)
- Investigational Product Name
- Ovitrelle 250 micrograms solution for injection in pre-filled pen
- Active Substance
- CHORIOGONADOTROPIN ALFA
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 250 micrograms (product name)
- Dose Levels
- maxDailyDoseAmount: 6500 IU (product data), maxTotalDoseAmount: 6500 IU
- Maximum Dose
- 6500 IU (product max daily/total as listed)
- Combination Treatment
- Yes
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