## Protocol Section
### Identification Module
**NCT ID:** NCT02335879

**Brief Title:** Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation

#### Organization Study ID Info
**ID:** GenSci 008 CT
#### Organization
**Class:** INDUSTRY
**Full Name:** Changchun GeneScience Pharmaceutical Co., Ltd.
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-01-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-01-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-08

**Type:** ACTUAL

#### Start Date
**Date:** 2008-05

**Status Verified Date:** 2015-01

#### Study First Post Date
**Date:** 2015-01-12
**Type:** ESTIMATED
**Study First Submit Date:** 2015-01-05
**Study First Submit QC Date:** 2015-01-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Peking University People's Hospital

**Class:** OTHER

**Name:** Peking University First Hospital

**Class:** OTHER

**Name:** Reproductive & Genetic Hospital of CITIC-Xiangya

**Class:** OTHER

**Name:** Qilu Hospital of Shandong University

**Class:** OTHER

**Name:** Wuhan Union Hospital, China

**Class:** OTHER

**Name:** Second Hospital of Jilin University

**Class:** OTHER

**Name:** Shengjing Hospital

**Class:** OTHER

**Name:** The First Affiliated Hospital of Dalian Medical University

**Class:** OTHER

**Name:** Second Affiliated Hospital of Wenzhou Medical University

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Changchun GeneScience Pharmaceutical Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the efficacy and safety of Domestic Recombinant Human Follitropin (Gonal-F) for Injection for treatment of WHO Ⅱ anovulation (including polycystic ovarian syndrome \[PCOS\] subjects).

### Conditions Module

**Conditions:**

- Anovulation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 534

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Biological: Gonal-F

**Label:** Recombinant Human Follitropin

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Recombinant Human Follitropin

**Name:** Gonal-F

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** The efficiency reached mature follicle (the diameter of follicular ≥18mm by type-B ultrasonic) within the start period on the day of HCG day.

**Time Frame:** 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.

**Maximum Age:** 38 Years

**Minimum Age:** 21 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010049

- Term: Ovarian Diseases

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000006058

- Term: Gonadal Disorders

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4184

- Name: Anovulation

- Relevance: HIGH

- As Found: Anovulation

- ID: M12972

- Name: Ovarian Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000858

- Term: Anovulation

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M8759

- Name: Follicle Stimulating Hormone

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
