Randomized Controlled Study of Comparing Follitrope Versus Gonal-f in Chinese Infertility Women.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Infertility, Female

Intervention / Treatment
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* Biological: Follitrope PFS
* Biological: Gonal-f pen


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Follitrope PFS | Biological: Follitrope PFS<br>* Follitrope PFS<br>|
| Active Comparator: Control group<br>Gonal-F pen | Biological: Gonal-f pen<br>* Gonal-f pen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total number of oocytes retrieved | The total number of oocytes retrieved | 15 days after using FSH | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose and duration of FSH administration | Total dose and duration of FSH administration | Throughout the study completion (e.g., 10 days) | 
| No. of follicles with diameter equal or more than 14 mm on hGH injection day | No. of follicles with diameter equal or more than 14 mm on hGH injection day | The day of hGH injection | 
| No. of embryo transferred | No. of embryo transferred | 3 days after the ovum pick-up | 
| Clinical pregnancy rate | Clinical pregnancy rate by g-sac | 5 weeks after the embryo transfer | 
| On-going pregnancy rate | On-going pregnancy rate by fetal heart-beat | 10 weeks after the embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, rhFSH