NCT03506243CompletedPhase 3
A Phase III, Multicenter, Blinded, Randomized, Controlled, Parallel, Comparative Study for the Evaluation of Safety and Efficacy of rhFSH Injection Compared With Gonal-F® Pen Undergoing Controlled Ovarian Hyper Stimulation IVF-ET
Hangzhou YuYuan Bioscience Technology Co., Ltd.1 site in 1 country451 target enrollmentStarted: April 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 451
- Locations
- 1
- Primary Endpoint
- The total number of oocytes retrieved
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Infertile adult women between 20 and 39 years at screening.
- •Infertile adult women with regular menstrual cycles of 25 to 35 days at screening.
- •Normal basal serum FSH, LH, E2, and P levels at the early follicular phase at screening.
- •If the cause of infertility is due to following reasons:
- •Tubal factor
- •Unknown reason
- •Male infertility
- •Combined factors
- •Willing to give voluntary written informed consent.
Exclusion Criteria
- •Patients with a clinically significant systemic disease, endocrine or metabolic abnormalities.
- •Body Mass Index > 30 (BMI; kg/m2) at screening.
- •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.
- •patients with uterine, ovarian surgery treatment
- •Patients who experienced of severe ovarian hyperstimulation symptoms (OHSS) in previous IVF cycles.
- •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.
- •Abnormal metrorrhagia due to unknown reason at screening.
- •At least one of husband and wife to accept donor sperm or donor eggs or PGD subject
- •Subjects who are positive for HIV or syphilis at screening.
- •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.
- •Presence of elicit alcohol, smoke or drug abuse habit at screening.
- •History of hypersensitivity to rhFSH or other pharmaceutical excipients of this drug.
- •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.
- •History of tumors of the ovary, breast, uterus, hypothalamus or pituary gland.
- •More than 3 times previously consecutive unsuccessful in vitro fertilization cycles at screening.
- •Subjects with no clomiphene citrate or gonadotropin treatment within 1 month before randomization.
- •Positive serum pregnancy test at screening.
- •14 ± 2 days after the demotion, results of subjects who does not belong to the standard (antral follicle size ≥10mm)
Arms & Interventions
Test group
Experimental
Follitrope PFS
Intervention: Follitrope PFS (Biological)
Control group
Active Comparator
Gonal-F pen
Intervention: Gonal-f pen (Biological)
Outcomes
Primary Outcomes
The total number of oocytes retrieved
Time Frame: 15 days after using FSH
The total number of oocytes retrieved
Secondary Outcomes
- Total dose and duration of FSH administration(Throughout the study completion (e.g., 10 days))
- Clinical pregnancy rate(5 weeks after the embryo transfer)
- No. of follicles with diameter equal or more than 14 mm on hGH injection day(The day of hGH injection)
- On-going pregnancy rate(10 weeks after the embryo transfer)
- No. of embryo transferred(3 days after the ovum pick-up)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Phase 3
To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for InjectionIdiopathic Hypogonadotropic HypogonadismNCT06561594Changchun GeneScience Pharmaceutical Co., Ltd.60
Unknown
Phase 3
FSH Treatment for Non-obstructive Azoospermic PatientsAzoospermiaNCT02275169Azienda Sanitaria Locale Bari200
Unknown
Phase 3
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before TransplantationDwarfismNCT03535415Changchun GeneScience Pharmaceutical Co., Ltd.68
Completed
Phase 1
Rekovelle PK Trial in Chinese WomenInfertilityNCT04150861Ferring Pharmaceuticals24
Unknown
Phase 3
Clinical Study of Recombinant Human Follitropin for Injection Assisted in COH Assisted IVF-ETOvarian Hyperstimulation SyndromeNCT03071172Changchun GeneScience Pharmaceutical Co., Ltd.252