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

Primary Purpose

Anovulation

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Gonal-F
Sponsored by
Changchun GeneScience Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anovulation

Eligibility Criteria

21 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Recombinant Human Follitropin

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2015
    Last Updated
    January 9, 2015
    Sponsor
    Changchun GeneScience Pharmaceutical Co., Ltd.
    Collaborators
    Peking University People's Hospital, Peking University First Hospital, Reproductive & Genetic Hospital of CITIC-Xiangya, Qilu Hospital of Shandong University, Wuhan Union Hospital, China, Second Hospital of Jilin University, Shengjing Hospital, The First Affiliated Hospital of Dalian Medical University, Second Affiliated Hospital of Wenzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02335879
    Brief Title
    Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Changchun GeneScience Pharmaceutical Co., Ltd.
    Collaborators
    Peking University People's Hospital, Peking University First Hospital, Reproductive & Genetic Hospital of CITIC-Xiangya, Qilu Hospital of Shandong University, Wuhan Union Hospital, China, Second Hospital of Jilin University, Shengjing Hospital, The First Affiliated Hospital of Dalian Medical University, Second Affiliated Hospital of Wenzhou Medical University

    4. Oversight

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anovulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    N/A
    Enrollment
    534 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Recombinant Human Follitropin
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    Gonal-F
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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