Infertility, Female
Conditions
Keywords
IVF, rhFSH
Brief summary
This study is for evaluating safety and efficacy of Recombinant human follicle-stimulating hormone (Follitrope) injection compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China
Detailed description
This is a Phase 3, multicenter, blinded, randomized, controlled, parallel, comparative study for the evaluation of safety and efficacy of Recombinant human follicle-stimulating hormone injection (Follitrope) compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China.
Interventions
BIOLOGICALFollitrope PFS
Follitrope PFS
BIOLOGICALGonal-f pen
Gonal-f pen
Sponsors
LG Chem
Hangzhou YuYuan Bioscience Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
1. Infertile adult women between 20 and 39 years at screening. 2. Infertile adult women with regular menstrual cycles of 25 to 35 days at screening. 3. Normal basal serum FSH, LH, E2, and P levels at the early follicular phase at screening. 4. If the cause of infertility is due to following reasons: * Tubal factor * Unknown reason * Male infertility * Combined factors 5. Willing to give voluntary written informed consent.
Exclusion criteria
1. Patients with a clinically significant systemic disease, endocrine or metabolic abnormalities. 2. Body Mass Index \> 30 (BMI; kg/m2) at screening. 3. Patients with a uterine (fibroids (diameter greater than or equal to 2CM endometrium), endometrial polyps, intrauterine adhesions, uterine malformations), ovaries (polycystic ovary, ovarian cysts) or adnexa (hydrosalpinx) abnormalities at screening. 4. patients with uterine, ovarian surgery treatment 5. Patients who experienced of severe ovarian hyperstimulation symptoms (OHSS) in previous IVF cycles. 6. Patients who have shown poor response with gonadotropin hormone therapy. \*At least two of the following three features must be present: ① A previous POR(≤3 retrieved oocyte with a conventional stimulation protocol) ② An abnormal ovarian reserve test (i.e. AFC \< 5 follicles) at screening. 7. Abnormal metrorrhagia due to unknown reason at screening. 8. At least one of husband and wife to accept donor sperm or donor eggs or PGD subject 9. Subjects who are positive for HIV or syphilis at screening. 10. Significant known psychiatric disorder or who unable to understand the objectives and methods, etc. of this clinical trial and unable to comply with the study procedures at screening. 11. Presence of elicit alcohol, smoke or drug abuse habit at screening. 12. History of hypersensitivity to rhFSH or other pharmaceutical excipients of this drug. 13. Participation in any other clinical trial after registering for this study or have participated in another clinical study within 3 month before randomization in this study. 14. History of tumors of the ovary, breast, uterus, hypothalamus or pituary gland. 15. More than 3 times previously consecutive unsuccessful in vitro fertilization cycles at screening. 16. Subjects with no clomiphene citrate or gonadotropin treatment within 1 month before randomization. 17. Positive serum pregnancy test at screening. 18. 14 ± 2 days after the demotion, results of subjects who does not belong to the standard (antral follicle size ≥10mm)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total number of oocytes retrieved | 15 days after using FSH | The total number of oocytes retrieved |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total dose and duration of FSH administration | Throughout the study completion (e.g., 10 days) | Total dose and duration of FSH administration |
| No. of follicles with diameter equal or more than 14 mm on hGH injection day | The day of hGH injection | No. of follicles with diameter equal or more than 14 mm on hGH injection day |
| No. of embryo transferred | 3 days after the ovum pick-up | No. of embryo transferred |
| Clinical pregnancy rate | 5 weeks after the embryo transfer | Clinical pregnancy rate by g-sac |
| On-going pregnancy rate | 10 weeks after the embryo transfer | On-going pregnancy rate by fetal heart-beat |
Countries
China
Outcome results
None listed