Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®
- Registration Number
- NCT01794208
- Lead Sponsor
- Glycotope GmbH
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 267
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description treatment 1 Follitropin Epsilon Follitropin Epsilon 52.5 IU quaque die (QD) s.c. treatment 6 Follitropin Alfa Follitropin alfa 150 IU QD s.c. treatment 2 Follitropin Epsilon Follitropin Epsilon 75 IU QD s.c. treatment 3 Follitropin Epsilon Follitropin Epsilon 112.5 IU QD s.c. treatment 4 Follitropin Epsilon Follitropin Epsilon 150 IU QD s.c. treatment 5 Follitropin Epsilon Follitropin Epsilon 150 IU quaque altera die (QAD) s.c.
- Primary Outcome Measures
Name Time Method Number of follicles day of hCG injection; variable timeframe; up to 18 days for maximum 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
Name Time Method Cumulus-oocyte-complexes at oocyte retrieval; 32 - 36 hours after hCG injection Number of retrieved cumulus-oocyte-complexes
Oocytes retrieved at oocyte retrieval; 32 - 36 hours after hCG injection Number of oocytes retrieved (metaphase II)
Follicular response every second day up to hCG injection; variable timeframe; up to 18 days for maximum 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
Two pronuclei oocytes one day after oocyte retrieval Number of two pronuclei (2PN) oocytes one day after follicle puncture
Biochemical pregnancy rate 14 to 20 days after oocyte retrieval Based on positive β-hCG pregnancy test
Clinical pregnancy rate approx. 4 to 6 weeks after last FSH dose Based on clinical or ultrasound parameters (gestational sac, foetal heart beat
Implantation rate approx. 4 to 6 weeks after last FSH dose Number of foetal sacs on sonography divided by number of embryos transferred per embryo transfer
Estradiol and inhibin B serum levels every second day up to hCG injection; variable timeframe; up to 18 days maximum Concentration of Estradiol and Inhibin B in Serum after FSH stimulation
Adverse events, ovarian hyperstimulation syndrome, anti-drug-antibodies, overall tolerability up to 4 to 6 weeks after last FSH dose Incidence of adverse events, ovarian hyperstimulation syndrome, anti-drug-antibodies, overall tolerability
Number of doses and total dose of FSH variable timeframe; up to 18 days for maximum The total dose is the amount of FSH-GEX(TM) or Gonal-f® administered to each patient during the stimulation period
Trial Locations
- Locations (2)
Glycotope Investigational Site
🇭🇺Tapolca, Hungary
Glycotope Investigational Medical Director
🇩🇪Bielefeld, Germany