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

Phase 3

Completed

• Conditions: Infertility, Female
• Interventions: Biological: Gonal-f pen; Biological: Follitrope PFS

• Registration Number: NCT03506243
• Lead Sponsor: Hangzhou YuYuan Bioscience Technology Co., Ltd.

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 Timeline

• Study Start: 2015-04
• Primary Completion: 2016-09
• Study Completion: 2017-05
• Status Verified: 2018-04
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-22
• Last Update Submitted: 2018-04-22
• Study First Posted: 2018-04-24
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 451

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Gonal-f pen	Gonal-F pen
Test group	Follitrope PFS	Follitrope PFS

Primary Outcome Measures

Name	Time	Method
The total number of oocytes retrieved	15 days after using FSH	The total number of oocytes retrieved

Secondary Outcome Measures

Name	Time	Method
Total dose and duration of FSH administration	Throughout the study completion (e.g., 10 days)	Total dose and duration of FSH administration
Clinical pregnancy rate	5 weeks after the embryo transfer	Clinical pregnancy rate by g-sac
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
On-going pregnancy rate	10 weeks after the embryo transfer	On-going pregnancy rate by fetal heart-beat
No. of embryo transferred	3 days after the ovum pick-up	No. of embryo transferred

Trial Locations

Locations (1)

Hangzhou Yuyuan Bioscience Technology Co.,Ltd; 🇨🇳 Hangzhou, Zhejiang, China