Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle
Conditions
Interventions
FE999049 group:FE999049 treatment
GONAL-F group:GONAL-F treatment
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Signed and dated Informed Consent Form for participation in the trial, obtained before any trial-related procedures; 2.Signed and dated Informed Consent Form for data collection on the neonate, obtained before randomisation to treatment; 3.In good physical and mental health in the judgement of the investigator; 4.Chinese pre-menopausal female between the ages of 20 and 40 years; 5.at least 20 years (including the 20th birthday) when signing the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomisation; 6.Eligible for ovarian stimulation with a dose equivalent to 150 IU GONAL-F or 225 IU GONAL-F, as judged by the investigator; 7.Body mass index (BMI) between 17.5 and 32.0 kg/m^2 (both inclusive) at screening; 8.Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor; 9.Infertility for at least one year before randomisation for subjects =35 years (criteria not applicable in case of tubal or severe male factor infertility); 10.Regular menstrual cycles of 21-35 days (both inclusive), presumed to be ovulatory; 11.Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. no endometrioma greater than 3 cm, and no enlarged ovaries or ovarian cyst not due to polycystic ovarian syndrome, which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) within 1 year prior to randomisation. Both ovaries must be accessible for oocyte retrieval; 12.Early follicular phase (cycle day 2-4) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (results obtained within 3 months prior to randomisation); 13.Serum anti-Müllerian hormone (AMH) concentration of =10 mm (including cysts that cannot be punctured prior to stimulation) observed by transvaginal ultrasound;
Exclusion criteria
Exclusion criteria: 1.Primary ovarian failure; 2.Known endometriosis stage III-IV (defined by the revised ASRM classification, 1996); 3.More than three previous controlled ovarian stimulation cycles initiated, regardless of outcome; 4.History of previous episode of ovarian hyperstimulation syndrome (OHSS), exuberant ovarian response to gonadotropins, or polycystic ovarian syndrome; 5.Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial with the exception of controlled thyroid function disease; 6.Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins; 7.Fibroid tumours of the uterus incompatible with pregnancy; 8.Currently breast-feeding; 9.Undiagnosed vaginal bleeding; 10.Findings at the gynaecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g. congenital uterine abnormalities or retained intrauterine device; 11.Pregnancy (negative urinary pregnancy tests must be documented at screening and before randomisation to treatment) or contraindication to pregnancy; 12.Use of fertility modifiers during the last menstrual cycle before randomisation, including dehydroepiandrosterone (DHEA) or cycle programming with oral contraceptives, progestogen or estrogen preparations; 13.Known inherited or acquired thrombophilia disease; 14.Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events; 15.Known porphyria; 16.Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial; 17.Previous participation in the trial; 18.Use of any non-registered investigational drugs during the last 3 months prior to randomisation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of oocytes retrieved; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of fertilised oocytes and fertilisation rate;Serum concentrations of estradiol and progesterone;Implantation rate;Clinical pregnancy rate;Vital pregnancy rate;Ongoing pregnancy rate;Early ovarian hyperstimulation syndrome (OHSS), late OHSS, and total OHSS;Ongoing implantation rate;Number of follicles;Live birth rate;Neonatal health, including minor/major congenital anomalies, at birth and at 4 weeks after birth;Positive ßhCG rate;Total gonadotropin dose and number of stimulation days; | — |
Countries
China
Contacts
Public ContactYingpu Sun
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed