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

• Status: Completed
• Trial end date: 2013-07-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glycotope GmbH
• Treatments: Follicle Stimulating Hormone

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