Clinical trial NCT05263388: A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 302
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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 eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI)
* Infertility for at least one year for participants ≤ 37 years or for at least 6 months for participants ≥ 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

Primary outcomes:
measure: Number of Oocytes Retrieved
timeFrame: On day of oocyte retrieval (Up to 22 days after start of stimulation)
Secondary outcomes:
measure: Number of Follicles (Total) at End-of-stimulation
timeFrame: At end-of-stimulation (up to 20 stimulation days)
measure: Size of the Follicles at End-of-stimulation
timeFrame: At end-of-stimulation (up to 20 stimulation days)
measure: Serum Concentrations of Estradiol at End-of-stimulation
timeFrame: At end-of-stimulation (up to 20 stimulation days)
measure: Serum Concentrations of Progesterone at End-of-stimulation
timeFrame: At end-of-stimulation (up to 20 stimulation days)
measure: Number of Fertilized Oocytes
timeFrame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
measure: Fertilization Rate
timeFrame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
measure: Number of Blastocysts and Number of Good Quality Blastocysts
timeFrame: On Day 5 or Day 6 (as applicable) after oocyte retrieval (up to 27 or 28 days after start of stimulation)
measure: Total Gonadotropin Dose
timeFrame: Up to 20 stimulation days
measure: Number of Stimulation Days
timeFrame: Up to 20 stimulation days
measure: Proportion of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Overall and by Grade) and/or Preventive Interventions for Early OHSS
timeFrame: Up to 9 days after triggering of final follicular maturation
Other outcomes:
Locations:
city: Wals-Seizenheim
country: Austria
facility: Ferring Investigational Site
state: Salzburg
city: Wien
country: Austria
facility: Ferring Investigational Site
city: Montpellier
country: France
facility: Ferring Investigational Site
city: Paris
country: France
facility: Ferring Investigational Site
city: Firenze
country: Italy
facility: Ferring Investigational Site
city: Milano
country: Italy
facility: Ferring Investigational Site
city: Napoli
country: Italy
facility: Ferring Investigational Site
city: Roma
country: Italy
facility: Ferring Investigational Site
city: Alicante
country: Spain
facility: Ferring Investigational Site
city: Barcelona
country: Spain
facility: Ferring Investigational Site
city: Bilbao
country: Spain
facility: Ferring Investigational Site
city: Madrid
country: Spain
facility: Ferring Investigational Site
city: Malaga
country: Spain
facility: Ferring Investigational Site
city: Valladolid
country: Spain
facility: Ferring Investigational Site
city: Coventry
country: United Kingdom
facility: Ferring Investigational Site
city: Liverpool
country: United Kingdom
facility: Ferring Investigational Site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: