Clinical trial
A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Ovarian Response of a Starting Dose of 15 μg Follitropin Delta (REKOVELLE) to a Starting Dose of 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme
Name
000401
Description
Hormone preparations like REKOVELLE and GONAL-F are used to make the body produce multiple egg sacs, allowing more eggs to be collected from women undergoing infertility treatment.
The main purpose of this trial is to see how many eggs are produced with a starting dose of 15 µg REKOVELLE compared to a starting dose of 225 IU GONAL-F. This research is intended to provide more knowledge about REKOVELLE, including the doses given in the trial.
Trial arms
Trial start
2022-07-10
Estimated PCD
2024-04-15
Trial end
2024-04-15
Status
Recruiting
Phase
Early phase I
Treatment
REKOVELLE (Follitropin Delta)
REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE is 15 μg fixed for the first four stimulation days. Dose adjustments may be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, can occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose can be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose is 5 μg and the maximum REKOVELLE is 20 μg. Subjects can be treated for a maximum of 20 days.
Arms:
REKOVELLE (Follitropin Delta)
GONAL-F (Follitropin Alfa)
GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F is 225 IU fixed for the first four stimulation days. Dose adjustments may be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, can occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose may be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose is 75 IU and the maximum GONAL-F dose is 300 IU. Subjects can be treated for a maximum of 20 days.
Arms:
GONAL-F (Follitropin Alfa)
Size
300
Primary endpoint
Number of oocytes retrieved
On day of oocyte retrieval (Up to 22 days after start of stimulation)
Eligibility criteria
Inclusion Criteria:
* Infertile women aged 18-40 years
* Diagnosed with tubal infertility, unexplained infertility, mild endometriosis (stage I/II) or partners with decreased sperm quality
* Medically prepared for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI)
* Infertility for at least one year for participants below 37 years or for at least 6 months for participants above 38 years
* Regular menstrual cycles of 21-35 days.
Exclusion Criteria:
* Known condition of not functioning ovaries
* Known advanced endometriosis (stage III/IV)
* Considered unsuitable for controlled ovarian stimulation with a dosing regimen corresponding to approximately 225 IU/day gonadotropin, as judged by the investigator
* History of previous episode of OHSS or exuberant ovarian response to gonadotropins, and polycystic ovarian syndrome
* Any known hormonal or metabolic abnormalities which can compromise participation in the trial
* Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2024-02-23
1 organization
Organization
Ferring Pharmaceuticals