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

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

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

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Biological: Follitrope PFS; Biological: Gonal-f pen

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 Type: Interventional
• Enrollment (Actual): 451
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310018
      • Hangzhou Yuyuan Bioscience Technology Co.,Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; Follitrope PFS	Biological: Follitrope PFS; Follitrope PFS
Active Comparator: Control group; Gonal-F pen	Biological: Gonal-f pen; Gonal-f pen

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hangzhou YuYuan Bioscience Technology Co., Ltd.
• Collaborators: LG Chem
• Investigators: Principal Investigator: Ying Pu Sun, the First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 22, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 22, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: IVF, rhFSH
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: TG1409CPL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No