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

NCT ID: NCT01794208

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 267 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-08
• Study Completion Date: 2013-07-30

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

treatment 1

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

Group Type: EXPERIMENTAL

Follitropin Epsilon

Intervention Type: DRUG

treatment 2

Follitropin Epsilon 75 IU QD s.c.

Group Type: EXPERIMENTAL

Follitropin Epsilon

Intervention Type: DRUG

treatment 3

Follitropin Epsilon 112.5 IU QD s.c.

Group Type: EXPERIMENTAL

Follitropin Epsilon

Intervention Type: DRUG

treatment 4

Follitropin Epsilon 150 IU QD s.c.

Group Type: EXPERIMENTAL

Follitropin Epsilon

Intervention Type: DRUG

treatment 5

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

Group Type: EXPERIMENTAL

Follitropin Epsilon

Intervention Type: DRUG

treatment 6

Follitropin alfa 150 IU QD s.c.

Group Type: ACTIVE_COMPARATOR

Follitropin Alfa

Intervention Type: DRUG

Interventions

Follitropin Epsilon

Intervention Type: DRUG

Follitropin Alfa

Intervention Type: DRUG

Other Intervention Names

FSH-GEX(TM); Gonal-f(R)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Glycotope GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Glycotope GmbH

Locations

Glycotope Investigational Site

Berlin, , Germany

Glycotope Investigational Site

Berlin, , Germany

Glycotope Investigational Medical Director

Bielefeld, , Germany

Glycotope Investigational Site

Düsseldorf, , Germany

Glycotope Investigational Site

Heidelberg, , Germany

Glycotope Investigational Site

Lübeck, , Germany

Glycotope Investigational Site

Budapest, , Hungary

Glycotope Investigational Site

Tapolca, , Hungary

Countries

Germany; Hungary

References

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.

Reference Type: RESULT

PMID: 31982355 (View on PubMed)

Other Identifiers

GEXGP24201

Identifier Type: -

Identifier Source: org_study_id