Status:
COMPLETED
Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®
Lead Sponsor:
Glycotope GmbH
Conditions:
Infertility
Eligibility:
FEMALE
18-37 years
Phase:
PHASE2
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 follic...
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 recomme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2013
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT01794208
Start Date
January 8 2013
End Date
July 30 2013
Last Update
May 7 2021
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Glycotope Investigational Site
Berlin, Germany, 10117
2
Glycotope Investigational Site
Berlin, Germany, 14050
3
Glycotope Investigational Medical Director
Bielefeld, Germany, 33619
4
Glycotope Investigational Site
Düsseldorf, Germany, 40219