Clinical trial • Phase IV • Other

FOLLITROPIN BETA for Subfertility

Phase IV trial of FOLLITROPIN BETA for Subfertility.

Overview

Trial Therapeutic Area
Other
Trial Disease
Subfertility
Trial Stage
Phase IV
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
27-06-2024

Trial design

Randomised, open-label, control arm: up to three modified natural cycles (mnc) (no specific drug detailed). intervention arm: a single corifollitropin alfa (cfa) stimulation (gnrh antagonist protocol); corifollitropin alfa product listed (elonva 150 micrograms solution for injection). Phase IV trial across 1 site in Belgium.

Randomised
Yes
Open Label
Yes
Comparator
Control arm: up to three Modified Natural Cycles (MNC) (no specific drug detailed). Intervention arm: a single corifollitropin alfa (CFA) stimulation (GnRH antagonist protocol); corifollitropin alfa product listed (Elonva 150 micrograms solution for injection).
Target Sample Size
300

Eligibility

Recruits 300 No vulnerable populations selected; only adult women (Age ≥ 18 and < 45). Informed consent is required: "Informed consent form (ICF) dated and signed" (subject information and ICF documents are listed in the trial documents). No assent process is specified..

Vulnerable Population
No vulnerable populations selected; only adult women (Age ≥ 18 and < 45). Informed consent is required: "Informed consent form (ICF) dated and signed" (subject information and ICF documents are listed in the trial documents). No assent process is specified.

Inclusion criteria

  • {"criterion_text":"- women with a clinical indication for ART with an expected low response to ovarian stimulation. Expected low prognosis will be defined according to the POSEIDON classification, which stratifies patients according to whether they have an unexpected (groups 1 and 2) or expected (groups 3 or 4) inappropriate ovarian response to gonadotropin stimulation. This trial only includes patients fulfilling the criteria of groups 3 or 4: • POSEIDON Group 3: patients < 35 years with poor ovarian reserve pre-stimulation parameters (AFC < 5 or AMH < 1.2 ng/ml*) • POSEIDON Group 4: patients ≥ 35 years with poor ovarian reserve pre-stimulation parameters (AFC < 5 or AMH < 1.2 ng/ml*) * AMH value should not be older than 12 months.\n- Informed consent form (ICF) dated and signed\n- Age ≥ 18 and < 45 years old\n- Body Mass Index (BMI) ≥ 18.5 kg/m² and < 35 kg/m²\n- Regular menstrual cycles (between 21 and 35 days)\n- Two ovaries present\n- Current pregnancy-wish\n- Single embryo transfer (SET)"}

Exclusion criteria

  • {"criterion_text":"- Basal FSH > 20 IU/L in the last 12 months\n- Simultaneous participation in another clinical study\n- Untreated and uncontrolled thyroid dysfunction\n- Tumors of the ovary, breast, uterus, pituitary or hypothalamus\n- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause\n- Malformations of the reproductive organs\n- Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy\n- Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin)\n- Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- the probability of having at least one good quality blastocyst after ART (on the day of embryo transfer) (binary endpoint).","definition_or_measurement_approach":"Binary endpoint assessed on the day of embryo transfer; 'good quality' is defined by the Gardner score 5AA, 5AB or 5BA."}

Secondary endpoints

  • {"endpoint_text":"- the relative number of blastocyts after ART (on the day of embryo transfer), relative to the number of oocytes (rate)","definition_or_measurement_approach":"Rate measured on the day of embryo transfer: number of blastocysts relative to number of oocytes retrieved."}
  • {"endpoint_text":"- the probability of having at least one blastocyst of good quality after ART (on the day of embryo transfer) (binary endpoint)","definition_or_measurement_approach":"Binary endpoint assessed on the day of embryo transfer; quality as per Gardner scoring."}
  • {"endpoint_text":"- the probability of having an ongoing pregnancy which is defined as 6 to 8 weeks gestational age (binary endpoint) o Related sensitivity endpoint:, as confirmed by ultrasound (time to event)","definition_or_measurement_approach":"Ongoing pregnancy defined as 6 to 8 weeks gestational age confirmed by ultrasound; includes time-to-event sensitivity analysis."}

Recruitment

Planned Sample Size
300
Recruitment Window Months
125
Consent Approach
Informed consent must be dated and signed by the participant. Participants are adult women (Age ≥ 18 and < 45). Subject information and ICF documents are listed (L1_ SIS and ICF adults and related documents). Protocol synopsis documents exist in Dutch and English (and other languages for the protocol synopsis), indicating materials are available in multiple languages; no assent process described.

Geography

Total Number Of Sites
1
Total Number Of Participants
300

Belgium

Earliest CTIS Part Ii Submission Date
10-01-2024
Latest Decision Or Authorization Date
28-04-2025
Processing Time Days
474
Number Of Sites
1
Number Of Participants
300

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Reproductive Medicine
Contact Person Name
Dominic Stoop
Contact Person Email
arg.studies@uzgent.be

Sponsor

Primary sponsor

Full Name
Universitair Ziekenhuis Gent
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
Puregon 150 IU/0.18 mL solution for injection
Active Substance
FOLLITROPIN BETA
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised (marketingAuthNumber: EU/1/96/008/040)
Starting Dose
150 IU
Maximum Dose
300 IU
Investigational Product Name
Puregon 300 IU/0.36 mL solution for injection
Active Substance
FOLLITROPIN BETA
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised (marketingAuthNumber: EU/1/96/008/038)
Starting Dose
300 IU
Maximum Dose
300 IU
Investigational Product Name
Puregon 600 IU/0.72 mL solution for injection
Active Substance
FOLLITROPIN BETA
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised (marketingAuthNumber: EU/1/96/008/039)
Starting Dose
600 IU
Maximum Dose
300 IU
Investigational Product Name
Puregon 900 IU/1.08 mL solution for injection
Active Substance
FOLLITROPIN BETA
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised (marketingAuthNumber: EU/1/96/008/041)
Starting Dose
900 IU
Maximum Dose
300 IU
Investigational Product Name
Elonva 150 micrograms solution for injection
Active Substance
CORIFOLLITROPIN ALFA
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised (marketingAuthNumber: EU/1/09/609/002)
Starting Dose
150 micrograms
Maximum Dose
150 micrograms
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
Route
Subcutaneous
Authorisation Status
Authorised (marketingAuthNumber: EU/1/00/165/007)
Starting Dose
250 micrograms
Maximum Dose
250 micrograms
Investigational Product Name
Orgalutran 0.25 mg/0.5 mL solution for injection
Active Substance
GANIRELIX
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised (marketingAuthNumber: EU/1/00/130/001 and EU/1/00/130/002 exist across products)
Starting Dose
0.25 mg
Maximum Dose
0.25 mg
Combination Treatment
Yes

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