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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794208
• Other study ID #: GEXGP24201
• Status: Completed
• Phase: Phase 2
• Start date: January 8, 2013
• Est. completion date: July 30, 2013

Study information

• Verified date: May 2021
• Source: Glycotope GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: July 30, 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Follitropin Epsilon

• Follitropin Alfa

Locations

Country	Name	City	State
Germany	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
Hungary	Glycotope Investigational Site	Budapest
Hungary	Glycotope Investigational Site	Tapolca

Sponsors (1)

Lead Sponsor	Collaborator
Glycotope GmbH

Countries where clinical trial is conducted

Germany,  Hungary, 

References & Publications (1)

Griesinger G, Dietrich B, Stöckl 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ongoing pregnancy rate	A pregnancy is considered an ongoing pregnancy if pregnancy can be confirmed for more than 10 weeks after gestation.	10 weeks after gestation
Other	Life birth rate	The live birth rate will be calculated as the total number of live births divided by the number of randomised patients	up to nine month after embryo transfer
Primary	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	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	every second day up to hCG injection; variable timeframe; up to 18 days for maximum
Secondary	Cumulus-oocyte-complexes	Number of retrieved cumulus-oocyte-complexes	at oocyte retrieval; 32 - 36 hours after hCG injection
Secondary	Oocytes retrieved	Number of oocytes retrieved (metaphase II)	at oocyte retrieval; 32 - 36 hours after hCG injection
Secondary	Two pronuclei oocytes	Number of two pronuclei (2PN) oocytes one day after follicle puncture	one day after oocyte retrieval
Secondary	Biochemical pregnancy rate	Based on positive ß-hCG pregnancy test	14 to 20 days after oocyte retrieval
Secondary	Clinical pregnancy rate	Based on clinical or ultrasound parameters (gestational sac, foetal heart beat	approx. 4 to 6 weeks after last FSH dose
Secondary	Implantation rate	Number of foetal sacs on sonography divided by number of embryos transferred per embryo transfer	approx. 4 to 6 weeks after last FSH dose
Secondary	Estradiol and inhibin B serum levels	Concentration of Estradiol and Inhibin B in Serum after FSH stimulation	every second day up to hCG injection; variable timeframe; up to 18 days maximum
Secondary	Adverse events, ovarian hyperstimulation syndrome, anti-drug-antibodies, overall tolerability	Incidence of adverse events, ovarian hyperstimulation syndrome, anti-drug-antibodies, overall tolerability	up to 4 to 6 weeks after last FSH dose
Secondary	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	variable timeframe; up to 18 days for maximum