female infertility MedDRA version: 16.0 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 100000004872
Conditions
Interventions
Trade Name: Fostimon
Product Name: Fostimon
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: Gonal-F
Product Name: Gonal-F
Pharmaceutical Form: Powder and solvent for so
Sponsors
IBSA Institut Biochimique S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule; -> =18 and =18 and 10 antral follicles 2-10 mm in size for both ovaries combined (measured day 2-4 of menstrual cycle) -AMH > 1 ng/ml (7.15 pmol/l) and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Age =39 years; -Primary ovarian failure or women known as poor responders (according to the Bologna criteria1); -PCO & PCOS (according to Rotterdam criteria2); -Severe OHSS in a previous COH cycle; -Uterine malformation that may impair the possibility to get pregnant; -Ovarian cysts >10 mm; -Hydrosalpinx that have not been surgically removed or ligated; -Endometriosis stage 3 or 4; -Oocyte donation; -Severe male factor -Patients affected by pathologies associated with any contraindication of being pregnant; -History of recurrent miscarriage (i.e. more than 3 previous miscarriages); -Hypersensitivity to the study medication; -Abnormal bleeding of undetermined origin; -Uncontrolled thyroid or adrenal dysfunction; -Neoplasias; -Severe impairment of renal and/or hepatic function; -use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon®, IBSA Institut Biochimique SA versus Gonal-F®) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle;Secondary Objective: 1) Ovarian stimulation 2) Oocyte quality 3) Embryo quality 4) Final result ;Primary end point(s): Clinical pregnancy rate, per stimulated cycle, per oocyte retrieval and per embryo transfer. A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation.;Timepoint(s) of evaluation of this end point: week 8 of pregnancy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Ovarian stimulation • Mean FSH dose (daily and total); • Number of days of FSH stimulation; • Number of follicles >16 mm on the day of hCG injection; • Progesterone and 17 beta-estradiol levels on the day of hCG triggering; • Cancellation rate with reasons. 2) Oocyte quality • Total number of oocytes retrieved; • Mean number of mature oocytes (grade III-metaphase II) and ratio MII/Total oocytes retrieved; • Mean number of immature oocytes and ration Immature/total oocytes retrieved; • Mean number inseminated/injected oocytes; • Fertilization rate: defined as the number of 2PN (or already cleaved) embryos on Day 1 divided by the total number of injected/ inseminated oocytes; • Cleavage rate: defined as the number of cleaved embryos on culture day 2 divided by the total number of injected/inseminated oocytes. 3) Embryo quality • Total number of embryos obtained, plus number transferred and frozen; • Embryo quality: assessment of blastomeres number and embryo morphology parameters: degree of fragmentation and cell division aspect. 4) Final result • Positive beta-hCG test per oocyte retrieval and per embryo transfer; • Implantation rate, defined as the ratio of the number of implanted embryos (presence of gestational sac assessed by ultrasound) and the number of transferred embryos. ;Timepoint(s) of evaluation of this end point: Ovarian stimulation: Visit 4 (induction of ovulation) Oocite quality: Visit 5 (oocyte collection) and V6 (embryo transfer) Embryo quality: Visit 6 (embryo transfer) Final result: visit 7 (pregnancy test) and Visit 8 (pregnancy confirmation and TVUS) | — |
Countries
Belgium, Italy, Spain, Switzerland, Turkey, United Kingdom
Contacts
Public ContactClinical Operations Department
LB Research srl
Outcome results
None listed