Randomized Controlled Study of Comparing Follitrope Versus Gonal-f in Chinese Infertility Women.
NCT ID: NCT03506243
Last Updated: 2018-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
451 participants
INTERVENTIONAL
2015-04-30
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Test group
Follitrope PFS
Follitrope PFS
Follitrope PFS
Control group
Gonal-F pen
Gonal-f pen
Gonal-f pen
Interventions
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Follitrope PFS
Follitrope PFS
Gonal-f pen
Gonal-f pen
Eligibility Criteria
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Inclusion Criteria
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
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)
20 Years
39 Years
FEMALE
No
Sponsors
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LG Chem
INDUSTRY
Hangzhou YuYuan Bioscience Technology Co., Ltd.
OTHER
Responsible Party
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Principal Investigators
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Ying Pu Sun
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Locations
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Hangzhou Yuyuan Bioscience Technology Co.,Ltd
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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TG1409CPL
Identifier Type: -
Identifier Source: org_study_id
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