Clinical trial • Not applicable • Other

Follitropin delta for Oocyte donation (oocyte donors)

Not applicable trial of Follitropin delta for Oocyte donation (oocyte donors).

Overview

Trial Therapeutic Area
Other
Trial Disease
Oocyte donation (oocyte donors)
Trial Stage
Not applicable
Drug Modality
Peptide/protein/enzyme | Small molecule

Key dates

Initial CTIS Submission Date
08-07-2024
First CTIS Authorization Date
31-07-2024

Trial design

Randomised, two treatment strategies compared in a crossover design: luteal phase ovarian stimulation (lpos) using a primed progestin ovarian stimulation (ppos) protocol versus conventional follicular phase stimulation using a ppos protocol. no drug doses or schedules for comparator arms are specified in the available data.-controlled, crossover Not applicable trial across 1 site in Belgium.

Randomised
Yes
Comparator
Two treatment strategies compared in a crossover design: Luteal phase Ovarian Stimulation (LPOS) using a Primed Progestin Ovarian Stimulation (PPOS) protocol versus conventional follicular phase stimulation using a PPOS protocol. No drug doses or schedules for comparator arms are specified in the available data.
Crossover
Yes
Target Sample Size
50

Eligibility

Recruits 50 No vulnerable population selected. All participants are adult women (Age ≥ 18 to ≤ 36). Signed informed consent is required. Assent procedures for minors are not applicable/not mentioned. Subject information and informed consent forms are available (adult ICF documents available in NL, FR, EN)..

Vulnerable Population
No vulnerable population selected. All participants are adult women (Age ≥ 18 to ≤ 36). Signed informed consent is required. Assent procedures for minors are not applicable/not mentioned. Subject information and informed consent forms are available (adult ICF documents available in NL, FR, EN).

Inclusion criteria

  • {"criterion_text":"- Age from≥ 18 to ≤ 36 years"}
  • {"criterion_text":"- BMI ≥18 to < 28"}
  • {"criterion_text":"- Signed informed consent"}
  • {"criterion_text":"- Regular menstrual cycle length i.e. 24-35 days"}

Exclusion criteria

  • {"criterion_text":"- Contraindications to the use of gonadotropins"}
  • {"criterion_text":"- Endometriosis grade 3-4"}
  • {"criterion_text":"- Patients with AMH <1.1 ng/ml and/or AFC<7"}
  • {"criterion_text":"- Patients with FNPO (Follicle Number Per Ovary) ≥ 19 and/or AMH >5ng/ml"}
  • {"criterion_text":"- Patients under contraception with hormonal IUD"}
  • {"criterion_text":"- Any untreated endocrine abnormality"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Total number of retrieved COCs","definition_or_measurement_approach":"Not specified in the available documents"}

Secondary endpoints

  • {"endpoint_text":"- Endocrine profile in both treatment groups","definition_or_measurement_approach":"Not specified in the available documents"}
  • {"endpoint_text":"- Consumption (mcg) of gonadotrophins","definition_or_measurement_approach":"Not specified in the available documents"}
  • {"endpoint_text":"- Duration of ovarian stimulation","definition_or_measurement_approach":"Not specified in the available documents"}
  • {"endpoint_text":"- Days of progestin use","definition_or_measurement_approach":"Not specified in the available documents"}
  • {"endpoint_text":"- Total number of MII oocytes","definition_or_measurement_approach":"Not specified in the available documents"}

Recruitment

Planned Sample Size
50
Recruitment Window Months
42
Consent Approach
Signed informed consent required from each participant (adult). Subject information and ICF documents are provided for adults; ICFs available in Dutch (NL), French (FR) and English (EN). No assent or minor consent procedures described.

Geography

Total Number Of Sites
1
Total Number Of Participants
50

Belgium

Earliest CTIS Part Ii Submission Date
16-07-2024
Latest Decision Or Authorization Date
31-07-2024
Processing Time Days
15
Number Of Sites
1
Number Of Participants
50

Sites

Site Name
UZ Brussel
Department Name
Brussels IVF
Principal Investigator Name
Christophe Blockeel
Principal Investigator Email
christophe.blockeel@uzbrussel.be
Contact Person Name
Christophe Blockeel

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen
Active Substance
Follitropin delta
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised
Maximum Dose
12 µg per day
Investigational Product Name
REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen
Active Substance
Follitropin delta
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised
Maximum Dose
12 µg per day
Investigational Product Name
Duphaston 10 mg filmomhulde tabletten
Active Substance
Dydrogesterone
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Maximum Dose
20 mg per day
Investigational Product Name
REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen
Active Substance
Follitropin delta
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised
Maximum Dose
12 µg per day
Investigational Product Name
Duphaston 10 mg comprimés pelliculés
Active Substance
Dydrogesterone
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Maximum Dose
20 mg per day
Investigational Product Name
Duphaston 10 mg Filmtabletten
Active Substance
Dydrogesterone
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Maximum Dose
20 mg per day
Combination Treatment
Yes

Related trials

Other published trials that may interest you.