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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506243
• Other study ID #: TG1409CPL
• Status: Completed
• Phase: Phase 3
• First received: April 11, 2018
• Last updated: April 22, 2018
• Start date: April 2015
• Est. completion date: May 2017

Study information

• Verified date: April 2018
• Source: Hangzhou YuYuan Bioscience Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: May 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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:

? A previous POR(=3 retrieved oocyte with a conventional stimulation protocol)

? 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)

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Biological:
• Follitrope PFS
Follitrope PFS
• Gonal-f pen
Gonal-f pen

Locations

Country	Name	City	State
China	Hangzhou Yuyuan Bioscience Technology Co.,Ltd	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Hangzhou YuYuan Bioscience Technology Co., Ltd.	LG Chem

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total number of oocytes retrieved	The total number of oocytes retrieved	15 days after using FSH
Secondary	Total dose and duration of FSH administration	Total dose and duration of FSH administration	Throughout the study completion (e.g., 10 days)
Secondary	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
Secondary	No. of embryo transferred	No. of embryo transferred	3 days after the ovum pick-up
Secondary	Clinical pregnancy rate	Clinical pregnancy rate by g-sac	5 weeks after the embryo transfer
Secondary	On-going pregnancy rate	On-going pregnancy rate by fetal heart-beat	10 weeks after the embryo transfer