Clinical trial • Not applicable • Other

Dydrogesterone for Female infertility

Not applicable trial of Dydrogesterone for Female infertility.

Overview

Trial Therapeutic Area
Other
Trial Disease
Female infertility
Trial Stage
Not applicable
Drug Modality
Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
30-07-2024
First CTIS Authorization Date
10-10-2024

Trial design

Randomised, conventional early follicular phase ovarian stimulation (comparator arm); specific drug doses/schedules not specified in ctis record.-controlled Not applicable trial across 1 site in Belgium.

Randomised
Yes
Comparator
Conventional early follicular phase ovarian stimulation (comparator arm); specific drug doses/schedules not specified in CTIS record.
Target Sample Size
277

Eligibility

Recruits 277 No vulnerable population selected. Participants must provide signed informed consent. Subject information and informed consent forms available in NL, FR and ENG..

Vulnerable Population
No vulnerable population selected. Participants must provide signed informed consent. Subject information and informed consent forms available in NL, FR and ENG.

Inclusion criteria

  • {"criterion_text":"- \tAge from ≥ 25 to ≤ 39 years"}
  • {"criterion_text":"- \tBody mass Index (BMI) ≥18 to < 30 kg/m2"}
  • {"criterion_text":"- \tSigned informed consent"}
  • {"criterion_text":"- \tRegular menstrual cycle length i.e. 24-35 days"}
  • {"criterion_text":"- \tPatients who are not taking hormonal contraception or who stopped hormonal contraception at least 2 months ago"}
  • {"criterion_text":"- \tNormally accessible ovaries/ ovary"}

Exclusion criteria

  • {"criterion_text":"- \tPatients currently taking hormonal contraception (including intrauterine devices)"}
  • {"criterion_text":"- \tContraindications to the use of gonadotropins"}
  • {"criterion_text":"- \tEndometriosis grade 3-4"}
  • {"criterion_text":"- \tPatients with Anti-müllerian hormone (AMH) <0.5 ng/mL (Revelli et al., JARG 2016) or AMH >3.2 ng/mL (Roche Diagnostics PCOM)"}
  • {"criterion_text":"- \tAny untreated endocrine abnormality"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Total number of mature cryopreserved oocytes per ovarian stimulation (OS) cycle in elective oocyte cryopreservation.","definition_or_measurement_approach":"Measured as the total number (count) of mature cryopreserved oocytes obtained per ovarian stimulation cycle."}

Secondary endpoints

  • {"endpoint_text":"- \tThe total number of oocytes retrieved","definition_or_measurement_approach":"Measured as the total number (count) of oocytes retrieved per cycle."}
  • {"endpoint_text":"- \tTotal consumption of gonadotropins (IU) used during Ovarian Stimulation","definition_or_measurement_approach":"Measured as total international units (IU) of gonadotropins administered during ovarian stimulation."}
  • {"endpoint_text":"- \tDuration of Ovarian Stimulation, defined as the time from the first day of stimulation until the application of the trigger for the final oocyte maturation","definition_or_measurement_approach":"Measured as number of days from first day of stimulation to trigger application."}

Recruitment

Planned Sample Size
277
Recruitment Window Months
36
Consent Approach
Signed informed consent required from participant. Subject information and informed consent forms available in NL, FR and ENG. No assent or proxy consent described.

Geography

Total Number Of Sites
1
Total Number Of Participants
277

Belgium

Earliest CTIS Part Ii Submission Date
24-09-2024
Latest Decision Or Authorization Date
05-02-2025
Processing Time Days
134
Number Of Sites
1
Number Of Participants
277

Sites

Site Name
Universitair Ziekenhuis Brussel
Department Name
Brussels IVF
Principal Investigator Name
Michel De Vos
Principal Investigator Email
michel.devos@uzbrussel.be
Contact Person Name
Michel De Vos
Contact Person Email
michel.devos@uzbrussel.be

Sponsor

Primary sponsor

Full Name
UZ Brussel
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
Duphaston 10 mg (dydrogesterone)
Active Substance
Dydrogesterone
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Marketing authorisation present (marketingAuthNumber: BE071951)
Maximum Dose
30 mg (max daily dose)
Investigational Product Name
Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen (follitropin alfa)
Active Substance
Follitropin alfa
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Marketing authorisation present (marketingAuthNumber: EU/1/13/909/004)
Maximum Dose
300 IU (max daily dose)
Investigational Product Name
Gonapeptyl Daily 0,1 mg/1 ml, solution injectable (triptorelin acetate)
Active Substance
Triptorelin acetate
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Marketing authorisation present (marketingAuthNumber: BE 339902)
Maximum Dose
0.2 mg/ml (max daily dose as listed)
Combination Treatment
Yes

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