Clinical trial NCT01794208: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Keywords: in-vitro fertilization
reproductive disorder
Lead sponsor: Glycotope GmbH
Sponsor class: INDUSTRY
First posted: 2013-02-18
Enrollment: 267
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of follicles
timeFrame: day of hCG injection; variable timeframe; up to 18 days for maximum
Secondary outcomes:
measure: Follicular response
timeFrame: every second day up to hCG injection; variable timeframe; up to 18 days for maximum
measure: Cumulus-oocyte-complexes
timeFrame: at oocyte retrieval; 32 - 36 hours after hCG injection
measure: Oocytes retrieved
timeFrame: at oocyte retrieval; 32 - 36 hours after hCG injection
measure: Two pronuclei oocytes
timeFrame: one day after oocyte retrieval
measure: Biochemical pregnancy rate
timeFrame: 14 to 20 days after oocyte retrieval
measure: Clinical pregnancy rate
timeFrame: approx. 4 to 6 weeks after last FSH dose
measure: Implantation rate
timeFrame: approx. 4 to 6 weeks after last FSH dose
measure: Estradiol and inhibin B serum levels
timeFrame: every second day up to hCG injection; variable timeframe; up to 18 days maximum
measure: Adverse events, ovarian hyperstimulation syndrome, anti-drug-antibodies, overall tolerability
timeFrame: up to 4 to 6 weeks after last FSH dose
measure: Number of doses and total dose of FSH
timeFrame: variable timeframe; up to 18 days for maximum
Other outcomes:
measure: Ongoing pregnancy rate
timeFrame: 10 weeks after gestation
measure: Life birth rate
timeFrame: up to nine month after embryo transfer
Locations:
city: Berlin
country: Germany
facility: Glycotope Investigational Site
city: Berlin
country: Germany
facility: Glycotope Investigational Site
city: Bielefeld
country: Germany
facility: Glycotope Investigational Medical Director
city: Düsseldorf
country: Germany
facility: Glycotope Investigational Site
city: Heidelberg
country: Germany
facility: Glycotope Investigational Site
city: Lübeck
country: Germany
facility: Glycotope Investigational Site
city: Budapest
country: Hungary
facility: Glycotope Investigational Site
city: Tapolca
country: Hungary
facility: Glycotope Investigational Site
Study officials:
affiliation: Glycotope GmbH
name: Study Director
role: STUDY_DIRECTOR
References:
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.