Phase III Clinical Study of Domestic Recombinant Human Fo... | NCT02335879

Studies
Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation

NCT02335879

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jan 12, 2015Estimated

Enrollment

534Actual

Phase

Phase 3

Conditions

Anovulation

Interventions

Gonal-F

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Not provided

First Submitted Date

Jan 5, 2015

First Submission Date that Met QC Criteria

Jan 9, 2015

First Posted Date

Jan 12, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2015

Last Update Posted Date

Jan 12, 2015Estimated

Name	Class
Peking University People's Hospital	OTHER
Peking University First Hospital	OTHER
Reproductive & Genetic Hospital of CITIC-Xiangya	OTHER
Qilu Hospital of Shandong University

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

534Actual

Label	Type	Description	Intervention Names
Recombinant Human Follitropin	Experimental		Biological: Gonal-F

Name	Type	Description	Arm Group Labels	Other Names
Gonal-F	Biological		Recombinant Human Follitropin

Measure	Description	Time Frame
The efficiency reached mature follicle (the diameter of follicular ≥18mm by type-B ultrasonic) within the start period on the day of HCG day.		participants will be followed within the HCG day, an expected average of 14±2 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Married infertile women at the age of 21-38.
BMI<28kg/m2.
According to the detection level of serum estradiol (E2), prolactin (PRL), progesterone (P), testosterone (T), luteinizing hormone (LH), follicle stimulating hormone (FSH), subjects were diagnosed of WHO class II anovulation or oligo-ovulation, and the above hormone level of the subject is normal or normal after treatment at the beginning of study, and FSH<10IU/L.
Bilateral fallopian tubes are unobstructed proved by hysterosalpingograph or laparoscopic examination within one year, no history of abortion or pelvic infection after the examination, the researcher decide whether the above examination need to repeat. If the subject had salpingoplasty under laparoscope, and the bilateral fallopian tubes are unobstructed after the surgery, there is no need to have the hysterosalpingograph. If it can not be confirmed, it must be done again to prove that the bilateral fallopian tubes are unobstructed.
Vaginal B-ultrasound examination shows that there is no ovarian pathological tumor, no hysteromyoma or hysteromyoma<4cm, and does not affect the endometrial function.
Two examinations of spouse semen are normal within six months, or comply with the IUI standard.
No history of drug abuse.
Voluntarily sign the informed consent form and agree with medication and accepting evaluation according to the requirements of the research protocol.

Exclusion Criteria:

The subject use gonadotropin therapy within the past three months (regardless the result of treatment).
The uterine factors affect pregnancy and other tumors.
Pregnancy contraindication, such as genetic diseases, mental diseases, drug abuse, sexually transmitted diseases, severe heart disease and hepatic and kidney function insufficiency.
Obscure vaginal bleeding.
Subjects are allergic to the application of FSH/HMG and HCG in the past.
Other conditions that the researchers think they are not suitable for the clinical trials.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases