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

Hangzhou YuYuan Bioscience Technology

Status and phase: Completed; Phase 3

Conditions: Infertility, Female

Treatments: Biological: Follitrope PFS; Biological: Gonal-f pen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03506243

TG1409CPL

Details and patient eligibility

About

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

Full 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.

Enrollment: 451 patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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451 participants in 2 patient groups

Test group

Experimental group

Description:

Follitrope PFS

Treatment:

Biological: Follitrope PFS

Control group

Active Comparator group

Description:

Gonal-F pen

Treatment:

Biological: Gonal-f pen