A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation

Infertility Clinical Trial

— ADAPT-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05263388
• Other study ID #: 000401
• Status: Completed
• Phase: Phase 3
• Start date: July 10, 2022
• Est. completion date: April 16, 2024

Study information

• Verified date: May 2024
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: April 16, 2024
• Est. primary completion date: April 16, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Austria	Ferring Investigational Site	Wals-Siezenheim
Austria	Ferring Investigational Site	Wien
France	Ferring Investigational Site	Montpellier
France	Ferring Investigational Site	Paris
Italy	Ferring Investigational Site	Firenze
Italy	Ferring Investigational Site	Milano
Italy	Ferring Investigational Site	Napoli
Italy	Ferring Investigational Site	Roma
Spain	Ferring Investigational Site	Alicante
Spain	Ferring Investigational Site	Barcelona
Spain	Ferring Investigational Site	Bilbao
Spain	Ferring Investigational Site	Madrid
Spain	Ferring Investigational Site	Malaga
Spain	Ferring Investigational Site	Valladolid
United Kingdom	Ferring Investigational Site	Coventry
United Kingdom	Ferring Investigational Site	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Austria,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes retrieved	The number of oocytes retrieved will be recorded at the oocyte retrieval visit.	On day of oocyte retrieval (Up to 22 days after start of stimulation)
Secondary	Number of follicles (total) at end-of-stimulation	Counted by ultrasound for the right and left ovary for each subject.	At end-of-stimulation (up to 20 stimulation days)
Secondary	Size of the follicles at end-of-stimulation	Counted by ultrasound for the right and left ovary for each subject.	At end-of-stimulation (up to 20 stimulation days)
Secondary	Serum concentrations of estradiol at end-of-stimulation	Blood samples for analysis of circulating concentrations of estradiol will be drawn.	At end-of-stimulation (up to 20 stimulation days)
Secondary	Serum concentrations of progesterone at end-of-stimulation	Blood samples for analysis of circulating concentrations of progesterone will be drawn.	At end-of-stimulation (up to 20 stimulation days)
Secondary	Number of fertilized oocytes	The number of pronuclei will be counted after insemination. Fertilized oocytes with 2 pronuclei (2PN) will be regarded as correctly fertilized.	On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Secondary	Fertilization rate	The fertilization rate was defined as the number of oocytes with 2PN divided by the number of oocytes retrieved.	On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Secondary	Number of Blastocysts and Number of Good Quality Blastocysts	Number of blastocysts and number of good quality blastocysts on Day 5 or 6 will be presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner & Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher.	On Day 5 or Day 6 (as applicable) after oocyte retrieval (up to 27 or 28 days after start of stimulation)
Secondary	Total gonadotropin dose	Calculated by start dates, end dates and daily dose of investigational medicinal product (IMP).	Up to 20 stimulation days
Secondary	Number of stimulation days	Calculated by start dates and end dates.	Up to 20 stimulation days
Secondary	Proportion of subjects with early ovarian hyperstimulation syndrome (OHSS) (overall and by grade) and/or preventive interventions for early OHSS	Early OHSS is defined as OHSS with onset =9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.	Up to 9 days after triggering of final follicular maturation