infertile but ovulatory women undergoing superovulation for assisted reproduction technologies MedDRA version: 12.1 Level: LLT Classification code 10016398 Term: Female infertility
Conditions
Interventions
Product Name: XM17
Product Code: XM17
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Follitropin alfa
CAS Number: not assigned
Current Sponsor code: XM17
Other descriptive name: reco
Sponsors
BioGeneriX AG
Eligibility
Sex/Gender
All
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/m2 inclusive. 6. Transvaginal ultrasound documenting the presence of both ovaries without abnormalities and normal adnexa within the last six 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 six months prior to study entry. 10. Negative pregnancy test prior to starting pituitary down-regulation. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. More than two previously completed consecutive unsuccessful IVF cycles (i.e. completed cycle = oocyte retrieval). 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 > 160 mmHg and diastolic blood pressure > 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 radiotherapy. 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 three years), current or past (three months) smoking habits of >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 |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate the equivalence of XM17 compared to Gonal-f® with respect to the primary efficacy endpoint of the number of oocytes retrieved in infertile but ovulatory women undergoing superovulation for ART.;Secondary Objective: 1. To compare the efficacy of XM17 against that of Gonal-f® with respect to: • Total recombinant human follicle-stimulating hormone (r-hFSH) dose (IU) and number of days of r-hFSH stimulation. • Number of patients needing dose adaptations. • Number of oocytes retrieved in patients with no r-hFSH adaptation. • Number of follicles (=10 mm, >10-14 mm, >14-17 mm, >17 mm) on stimulation Day 6 prior to dose adaptation and number of follicles >14 mm on the day of human chorionic gonadotropin (hCG) injection. • 17-ß estradiol serum concentration on stimulation Day 6 and on the day of hCG injection. • Endometrial thickness on stimulation Day 6 prior to dose adaptation and on the day of hCG administration. • Cancellation rate prior to oocyte retrieval. • Oocyte maturity. • Oocyte quality. • Fertilisation rate. • Clinical pregnancy rate. 2. To demonstrate the safety and tolerability of XM17 compared to Gonal-f® in women undergoing ART.;Primary end point(s): Number of oocytes retrieved in the main study | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Poland
Outcome results
None listed