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Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Follitropin Epsilon
Follitropin Alfa
Sponsored by
Glycotope GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring in-vitro fertilization, reproductive disorder

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patient for whom ICSI treatment is justified
  • Serum follicle-stimulating hormone concentration
  • Anti-mullerian hormone concentration
  • Antral follicle count
  • Body mass index and body weight
  • Presence of both ovaries
  • Regular spontaneous cycles between 21 and 35 days in length
  • Normal uterine cavity as assessed by transvaginal sonography at Screening
  • Willing and able to comply with the protocol
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Patients who had more than two unsuccessful previous assisted reproduction technology cycles before inclusion into the study
  • Previous poor responders
  • Patients with previous hyperstimulation syndrome or cycle cancellation because of imminent hyperstimulation syndrome
  • Patients with a history of or current polycystic ovarian morphology syndrome
  • Patients with a history of or current endometriosis III or IV
  • Presence of ovarian cyst at Screening
  • Any contraindication to becoming pregnant
  • History of ≥ 3 clinical or preclinical miscarriages
  • Abnormal cervical smear, Papanicolaou [PAP] score ≥ 3
  • Any history of malignant cancer other than in situ breast or skin cancer requiring local excision
  • Any endocrine abnormalities requiring treatment
  • Any clinically significant systematic disease
  • Any known infection with human immunodeficiency virus, hepatitis B or C
  • History of thrombosis or other risk factors including any coagulation abnormality leading to an increased risk of clotting
  • Family history of genetic risk factors concerning pregnancy or birth
  • Use of concomitant medication, which in the opinion of the investigator might interfere with ICSI preparation procedures
  • Active smoking
  • Any active substance abuse of drugs, medications or alcohol within the last five years
  • Patients in an institution by official or court order
  • Patients who are unable or unwilling to provide informed consent
  • Any participation in another clinical trial within the last 60 days before randomisation
  • Previous FSH-GEX™ administration.
  • Known hypersensitivity to any component of the investigational and non investigational products used in this study

Sites / Locations

  • Glycotope Investigational Site
  • Glycotope Investigational Site
  • Glycotope Investigational Medical Director
  • Glycotope Investigational Site
  • Glycotope Investigational Site
  • Glycotope Investigational Site
  • Glycotope Investigational Site
  • Glycotope Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

treatment 1

treatment 2

treatment 3

treatment 4

treatment 5

treatment 6

Arm Description

Follitropin Epsilon 52.5 IU quaque die (QD) s.c.

Follitropin Epsilon 75 IU QD s.c.

Follitropin Epsilon 112.5 IU QD s.c.

Follitropin Epsilon 150 IU QD s.c.

Follitropin Epsilon 150 IU quaque altera die (QAD) s.c.

Follitropin alfa 150 IU QD s.c.

Outcomes

Primary Outcome Measures

Number of follicles
The number of follicles with a diameter of ≥ 12 mm on the day of human chorionic gonadotropin (hCG) injection after stimulation with follicle stimulating hormone (FSH)

Secondary Outcome Measures

Follicular response
For each ovary the number of follicles were classified and summarised as follows: mean diameter 8.0 - 9.9 mm, 10.0 - 11.9 mm, 12.0 - 13.9 mm, 14.0 - 15.9 mm, 16.0 - 17.9 mm, 18.0 - 19.9 mm, and >19.9 mm as determined by transvaginal ultrasonography
Cumulus-oocyte-complexes
Number of retrieved cumulus-oocyte-complexes
Oocytes retrieved
Number of oocytes retrieved (metaphase II)
Two pronuclei oocytes
Number of two pronuclei (2PN) oocytes one day after follicle puncture
Biochemical pregnancy rate
Based on positive β-hCG pregnancy test
Clinical pregnancy rate
Based on clinical or ultrasound parameters (gestational sac, foetal heart beat
Implantation rate
Number of foetal sacs on sonography divided by number of embryos transferred per embryo transfer
Estradiol and inhibin B serum levels
Concentration of Estradiol and Inhibin B in Serum after FSH stimulation
Adverse events, ovarian hyperstimulation syndrome, anti-drug-antibodies, overall tolerability
Incidence of adverse events, ovarian hyperstimulation syndrome, anti-drug-antibodies, overall tolerability
Number of doses and total dose of FSH
The total dose is the amount of FSH-GEX(TM) or Gonal-f® administered to each patient during the stimulation period

Full Information

First Posted
January 23, 2013
Last Updated
May 4, 2021
Sponsor
Glycotope GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01794208
Brief Title
Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®
Official Title
A Phase II, Multicentre, Multinational, Randomised, Assessor-Blind Trial to Investigate the Efficacy and Safety of Various Dosages of FSH-GEX™ in Comparison With 150 IU Gonal-f® in Women Undergoing ICSI Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2013 (Actual)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glycotope GmbH

4. Oversight

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

5. Study Description

Brief Summary
The aim of the current study was the determination of the recommended standard treatment dose of FSH-GEX(TM) in women undergoing intracytoplasmic sperm injection (ICSI) treatment as assessed by follicle growth.
Detailed Description
This was a phase II, randomized, assessor-blind, comparator-controlled, multiple dose study in women undergoing ICSI treatment. The primary objective of the study was the determination of the recommended standard treatment dose of FSH-GEX™ as assessed by follicle growth dynamics in women between 18 and 37 years of age who were undergoing intracytoplasmic sperm injection treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
in-vitro fertilization, reproductive disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment 1
Arm Type
Experimental
Arm Description
Follitropin Epsilon 52.5 IU quaque die (QD) s.c.
Arm Title
treatment 2
Arm Type
Experimental
Arm Description
Follitropin Epsilon 75 IU QD s.c.
Arm Title
treatment 3
Arm Type
Experimental
Arm Description
Follitropin Epsilon 112.5 IU QD s.c.
Arm Title
treatment 4
Arm Type
Experimental
Arm Description
Follitropin Epsilon 150 IU QD s.c.
Arm Title
treatment 5
Arm Type
Experimental
Arm Description
Follitropin Epsilon 150 IU quaque altera die (QAD) s.c.
Arm Title
treatment 6
Arm Type
Active Comparator
Arm Description
Follitropin alfa 150 IU QD s.c.
Intervention Type
Drug
Intervention Name(s)
Follitropin Epsilon
Other Intervention Name(s)
FSH-GEX(TM)
Intervention Type
Drug
Intervention Name(s)
Follitropin Alfa
Other Intervention Name(s)
Gonal-f(R)
Primary Outcome Measure Information:
Title
Number of follicles
Description
The number of follicles with a diameter of ≥ 12 mm on the day of human chorionic gonadotropin (hCG) injection after stimulation with follicle stimulating hormone (FSH)
Time Frame
day of hCG injection; variable timeframe; up to 18 days for maximum
Secondary Outcome Measure Information:
Title
Follicular response
Description
For each ovary the number of follicles were classified and summarised as follows: mean diameter 8.0 - 9.9 mm, 10.0 - 11.9 mm, 12.0 - 13.9 mm, 14.0 - 15.9 mm, 16.0 - 17.9 mm, 18.0 - 19.9 mm, and >19.9 mm as determined by transvaginal ultrasonography
Time Frame
every second day up to hCG injection; variable timeframe; up to 18 days for maximum
Title
Cumulus-oocyte-complexes
Description
Number of retrieved cumulus-oocyte-complexes
Time Frame
at oocyte retrieval; 32 - 36 hours after hCG injection
Title
Oocytes retrieved
Description
Number of oocytes retrieved (metaphase II)
Time Frame
at oocyte retrieval; 32 - 36 hours after hCG injection
Title
Two pronuclei oocytes
Description
Number of two pronuclei (2PN) oocytes one day after follicle puncture
Time Frame
one day after oocyte retrieval
Title
Biochemical pregnancy rate
Description
Based on positive β-hCG pregnancy test
Time Frame
14 to 20 days after oocyte retrieval
Title
Clinical pregnancy rate
Description
Based on clinical or ultrasound parameters (gestational sac, foetal heart beat
Time Frame
approx. 4 to 6 weeks after last FSH dose
Title
Implantation rate
Description
Number of foetal sacs on sonography divided by number of embryos transferred per embryo transfer
Time Frame
approx. 4 to 6 weeks after last FSH dose
Title
Estradiol and inhibin B serum levels
Description
Concentration of Estradiol and Inhibin B in Serum after FSH stimulation
Time Frame
every second day up to hCG injection; variable timeframe; up to 18 days maximum
Title
Adverse events, ovarian hyperstimulation syndrome, anti-drug-antibodies, overall tolerability
Description
Incidence of adverse events, ovarian hyperstimulation syndrome, anti-drug-antibodies, overall tolerability
Time Frame
up to 4 to 6 weeks after last FSH dose
Title
Number of doses and total dose of FSH
Description
The total dose is the amount of FSH-GEX(TM) or Gonal-f® administered to each patient during the stimulation period
Time Frame
variable timeframe; up to 18 days for maximum
Other Pre-specified Outcome Measures:
Title
Ongoing pregnancy rate
Description
A pregnancy is considered an ongoing pregnancy if pregnancy can be confirmed for more than 10 weeks after gestation.
Time Frame
10 weeks after gestation
Title
Life birth rate
Description
The live birth rate will be calculated as the total number of live births divided by the number of randomised patients
Time Frame
up to nine month after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patient for whom ICSI treatment is justified Serum follicle-stimulating hormone concentration Anti-mullerian hormone concentration Antral follicle count Body mass index and body weight Presence of both ovaries Regular spontaneous cycles between 21 and 35 days in length Normal uterine cavity as assessed by transvaginal sonography at Screening Willing and able to comply with the protocol Willing and able to provide written informed consent Exclusion Criteria: Patients who had more than two unsuccessful previous assisted reproduction technology cycles before inclusion into the study Previous poor responders Patients with previous hyperstimulation syndrome or cycle cancellation because of imminent hyperstimulation syndrome Patients with a history of or current polycystic ovarian morphology syndrome Patients with a history of or current endometriosis III or IV Presence of ovarian cyst at Screening Any contraindication to becoming pregnant History of ≥ 3 clinical or preclinical miscarriages Abnormal cervical smear, Papanicolaou [PAP] score ≥ 3 Any history of malignant cancer other than in situ breast or skin cancer requiring local excision Any endocrine abnormalities requiring treatment Any clinically significant systematic disease Any known infection with human immunodeficiency virus, hepatitis B or C History of thrombosis or other risk factors including any coagulation abnormality leading to an increased risk of clotting Family history of genetic risk factors concerning pregnancy or birth Use of concomitant medication, which in the opinion of the investigator might interfere with ICSI preparation procedures Active smoking Any active substance abuse of drugs, medications or alcohol within the last five years Patients in an institution by official or court order Patients who are unable or unwilling to provide informed consent Any participation in another clinical trial within the last 60 days before randomisation Previous FSH-GEX™ administration. Known hypersensitivity to any component of the investigational and non investigational products used in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Glycotope GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Glycotope Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Glycotope Investigational Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Glycotope Investigational Medical Director
City
Bielefeld
ZIP/Postal Code
33619
Country
Germany
Facility Name
Glycotope Investigational Site
City
Düsseldorf
ZIP/Postal Code
40219
Country
Germany
Facility Name
Glycotope Investigational Site
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Glycotope Investigational Site
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Glycotope Investigational Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Glycotope Investigational Site
City
Tapolca
ZIP/Postal Code
8300
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31982355
Citation
Griesinger G, Dietrich B, Stockl L, Eckert K, Goletz S, Tandler-Schneider A. Fully human glyco-optimized recombinant FSH (follitropin epsilon) - a randomized, comparator-controlled phase II clinical trial. Reprod Biomed Online. 2020 Feb;40(2):331-341. doi: 10.1016/j.rbmo.2019.09.003. Epub 2019 Sep 16.
Results Reference
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Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®

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