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

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

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.

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.

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