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

NCT01794208 | Completed Phase 2

• 1 other identifier: GEXGP24201
• Study Type: interventional
• Target: 267
• Locations: 2 countries
• Sites: 8

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.

Conditions

Infertility

Keywords

in-vitro fertilization; reproductive disorder

Outcome Measures

Primary Outcomes (1)

• 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)

  day of hCG injection; variable timeframe; up to 18 days for maximum

Secondary Outcomes (10)

• Follicular response

  every second day up to hCG injection; variable timeframe; up to 18 days for maximum

• Cumulus-oocyte-complexes

  at oocyte retrieval; 32 - 36 hours after hCG injection

• Oocytes retrieved

  at oocyte retrieval; 32 - 36 hours after hCG injection

• Two pronuclei oocytes

  one day after oocyte retrieval

• Biochemical pregnancy rate

  14 to 20 days after oocyte retrieval

Other Outcomes (2)

• Ongoing pregnancy rate

  10 weeks after gestation

• Life birth rate

  up to nine month after embryo transfer

Study Arms (6)

treatment 1

EXPERIMENTAL

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

Drug: Follitropin Epsilon

treatment 2

EXPERIMENTAL

Follitropin Epsilon 75 IU QD s.c.

Drug: Follitropin Epsilon

treatment 3

EXPERIMENTAL

Follitropin Epsilon 112.5 IU QD s.c.

Drug: Follitropin Epsilon

treatment 4

EXPERIMENTAL

Follitropin Epsilon 150 IU QD s.c.

Drug: Follitropin Epsilon

treatment 5

EXPERIMENTAL

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

Drug: Follitropin Epsilon

treatment 6

ACTIVE COMPARATOR

Follitropin alfa 150 IU QD s.c.

Drug: Follitropin Alfa

Interventions

Follitropin Epsilon DRUG

Also known as: FSH-GEX(TM)

treatment 1; treatment 2; treatment 3; treatment 4; treatment 5

Follitropin Alfa DRUG

Also known as: Gonal-f(R)

treatment 6

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glycotope GmbH: lead

Study Sites (8)

Glycotope Investigational Site

Berlin, 10117, Germany

Location

Glycotope Investigational Site

Berlin, 14050, Germany

Location

Glycotope Investigational Medical Director

Bielefeld, 33619, Germany

Location

Glycotope Investigational Site

Düsseldorf, 40219, Germany

Location

Glycotope Investigational Site

Heidelberg, 69115, Germany

Location

Glycotope Investigational Site

Lübeck, 23538, Germany

Location

Glycotope Investigational Site

Budapest, 1125, Hungary

Location

Glycotope Investigational Site

Tapolca, 8300, Hungary

Location

Related Publications (1)

• 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.

  PMID: 31982355 RESULT

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Study Director

  Glycotope GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: February 18, 2013
• Study Start: January 8, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 30, 2013
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6); HU (2)