Infertility
Conditions
Keywords
in-vitro fertilization, reproductive disorder
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.
Interventions
DRUGFollitropin Epsilon
DRUGFollitropin Alfa
Sponsors
Glycotope GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 10 weeks after gestation | A pregnancy is considered an ongoing pregnancy if pregnancy can be confirmed for more than 10 weeks after gestation. |
| Life birth rate | up to nine month after embryo transfer | The live birth rate will be calculated as the total number of live births divided by the number of randomised patients |
Countries
Germany, Hungary
Outcome results
None listed