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A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation (ADAPT-1)

Primary Purpose

Infertility

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
REKOVELLE (Follitropin Delta)
GONAL-F (Follitropin Alfa)
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational Site
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

REKOVELLE (Follitropin Delta)

GONAL-F (Follitropin Alfa)

Arm Description

Outcomes

Primary Outcome Measures

Number of oocytes retrieved
The number of oocytes retrieved will be recorded at the oocyte retrieval visit.

Secondary Outcome Measures

Number of follicles (total) at end-of-stimulation
Counted by ultrasound for the right and left ovary for each subject.
Size of the follicles at end-of-stimulation
Counted by ultrasound for the right and left ovary for each subject.
Serum concentrations of estradiol at end-of-stimulation
Blood samples for analysis of circulating concentrations of estradiol will be drawn.
Serum concentrations of progesterone at end-of-stimulation
Blood samples for analysis of circulating concentrations of progesterone will be drawn.
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.
Fertilization rate
The fertilization rate was defined as the number of oocytes with 2PN divided by the number of oocytes retrieved.
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.
Total gonadotropin dose
Calculated by start dates, end dates and daily dose of investigational medicinal product (IMP).
Number of stimulation days
Calculated by start dates and end dates.
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.

Full Information

First Posted
November 16, 2021
Last Updated
September 6, 2023
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05263388
Brief Title
A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2022 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REKOVELLE (Follitropin Delta)
Arm Type
Experimental
Arm Title
GONAL-F (Follitropin Alfa)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
REKOVELLE (Follitropin Delta)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
GONAL-F (Follitropin Alfa)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of oocytes retrieved
Description
The number of oocytes retrieved will be recorded at the oocyte retrieval visit.
Time Frame
On day of oocyte retrieval (Up to 22 days after start of stimulation)
Secondary Outcome Measure Information:
Title
Number of follicles (total) at end-of-stimulation
Description
Counted by ultrasound for the right and left ovary for each subject.
Time Frame
At end-of-stimulation (up to 20 stimulation days)
Title
Size of the follicles at end-of-stimulation
Description
Counted by ultrasound for the right and left ovary for each subject.
Time Frame
At end-of-stimulation (up to 20 stimulation days)
Title
Serum concentrations of estradiol at end-of-stimulation
Description
Blood samples for analysis of circulating concentrations of estradiol will be drawn.
Time Frame
At end-of-stimulation (up to 20 stimulation days)
Title
Serum concentrations of progesterone at end-of-stimulation
Description
Blood samples for analysis of circulating concentrations of progesterone will be drawn.
Time Frame
At end-of-stimulation (up to 20 stimulation days)
Title
Number of fertilized oocytes
Description
The number of pronuclei will be counted after insemination. Fertilized oocytes with 2 pronuclei (2PN) will be regarded as correctly fertilized.
Time Frame
On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Title
Fertilization rate
Description
The fertilization rate was defined as the number of oocytes with 2PN divided by the number of oocytes retrieved.
Time Frame
On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Title
Number of Blastocysts and Number of Good Quality Blastocysts
Description
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.
Time Frame
On Day 5 or Day 6 (as applicable) after oocyte retrieval (up to 27 or 28 days after start of stimulation)
Title
Total gonadotropin dose
Description
Calculated by start dates, end dates and daily dose of investigational medicinal product (IMP).
Time Frame
Up to 20 stimulation days
Title
Number of stimulation days
Description
Calculated by start dates and end dates.
Time Frame
Up to 20 stimulation days
Title
Proportion of subjects with early ovarian hyperstimulation syndrome (OHSS) (overall and by grade) and/or preventive interventions for early OHSS
Description
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.
Time Frame
Up to 9 days after triggering of final follicular maturation

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Global Clinical Compliance
Phone
+1 833-548-1402 (US/Canada)
Email
DK0-Disclosure@ferring.com
First Name & Middle Initial & Last Name or Official Title & Degree
Global Clinical Compliance
Phone
+1 862-286-5200 (outside US)
Email
DK0-Disclosure@ferring.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Compliance
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Ferring Investigational Site
City
Wals-Siezenheim
Country
Austria
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Wien
Country
Austria
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Paris
Country
France
Individual Site Status
Suspended
Facility Name
Ferring Investigational Site
City
Firenze
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Alicante
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Bilbao
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Malaga
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Valladolid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Coventry
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Liverpool
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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