Infertility Urological and Genital Diseases Female infertility
Conditions
Interventions
After checking the suitability of the patient, the patients will be down-regulated with a gonadotropin releasing hormone agonist. After successful down-regulation the patients will be randomised to a
Sponsors
BioGeneriX AG (Germany)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Infertile female patients of any racial origin undergoing superovulation for ART 2. Aged 18 - 37 years (inclusive) at the time of enrolment 3. Good physical and mental health 4. Regular menstrual cycles of 21 - 35 days and presumed to be ovulatory 5. Body mass index (BMI) between 18 - 29 kg/m^2 inclusive 6. Transvaginal ultrasound documenting the presence of both ovaries without abnormalities and normal adnexa within the last 6 months 7. Basal follicle stimulating hormone (FSH), estradiol, prolactin, thyroid stimulating hormone (TSH) within the normal reference ranges at enrolment 8. Normal or clinically insignificant haematology, clinical chemistry and urinalysis parameters 9. Negative cervical Pap test within the last 6 months prior to study entry 10. Negative pregnancy test prior to starting pituitary downregulation 11. Able to understand and follow instructions and able to participate in the study for the entire period 12. Signed and dated written informed consent
Exclusion criteria
Exclusion criteria: 1. More than two previously completed consecutive unsuccessful in-vitro fertilisation (IVF) cycles 2. Primary ovarian failure or women known as poor responders 3. More than three miscarriages 4. History of a severe ovarian hyperstimulation syndrome (OHSS) 5. Malformations of sexual organs incompatible with pregnancy 6. One or both ovaries inaccessible for oocyte retrieval 7. Ovarian enlargement or cyst of more than 2 cm 8. Hydrosalpinx that has not been surgically removed or ligated 9. Patient affected by pathologies associated with any contraindication of being pregnant 10. Gynaecological haemorrhages of unknown aetiology 11. Uncontrolled moderate arterial hypertension defined as systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 100 mmHg 12. Any significant cardiovascular, pulmonary, neurologic, allergic, endocrine, hepatic, renal or systemic disease 13. Patient with insulin-dependent diabetes mellitus 14. History of coagulation disorders 15. Known positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B or hepatitis C 16. Neoplasm (e.g. tumours of the ovary, breast, uterus, hypothalamus or pituitary gland) 17. History of chemo- or radio-therapy 18. Use of concomitant medications that might interfere with study evaluations (e.g., prostaglandin inhibitors, psychotropic agents) 19. Known allergy or hypersensitivity to recombinant FSH preparations or one of their excipients 20. History of drug or alcohol abuse (last 3 years), current or past (3 months) smoking habits of greater than 10 cigarettes per day 21. Pregnancy or lactation at enrolment 22. Administration of clomiphene or gonadotropins within 30 days prior to enrolment 23. Administration of investigational drugs within 90 days prior to enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of cumulus oocyte complexes retrieved | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1. Total r-hFSH dose 2. Number of days of r-hFSH stimulation 3. Number of follicles, 17-ß estradiol serum concentration and endometrial thickness on stimulation Day 6 prior to dose adaptation and on the day of hCG injection 4. Cancellation rate 5. Oocyte maturity and quality 6. Fertilisation rate 7. Clinical pregnancy rate Safety: 8. Frequency of OHSS 9. Adverse events 10. Vital signs 11. Laboratory tests 12. Physical examination, body weight 13. 12-lead electrocardiogram (ECG) 14. Tolerability (overall and local) 15. Immunogenicity (anti-FSH antibody formation) | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Poland, United Kingdom
Outcome results
None listed