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Clinical Study of Recombinant Human Follitropin for Injection Assisted in COH Assisted IVF-ET

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ClinicalTrials.gov Identifier: NCT03071172
Recruitment Status : Unknown
Verified February 2017 by GeneScience Pharmaceuticals Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Collaborators:
Peking University Third Hospital
The First Affiliated Hospital with Nanjing Medical University
Women's Hospital School Of Medicine Zhejiang University
Xiangya Hospital of Central South University
Sixth Affiliated Hospital, Sun Yat-sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The First Affiliated Hospital of Anhui Medical University
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

Tracking Information
First Submitted Date  ICMJE February 20, 2017
First Posted Date  ICMJE March 6, 2017
Last Update Posted Date March 6, 2017
Estimated Study Start Date  ICMJE March 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
The total number of oocytes obtained during the start-up period [ Time Frame: On the days of ovum picking up (hCG trigger 36-38h) ]
Routine ova harvest to determine the number of obtained oocytes
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
  • The number of follicle-1 [ Time Frame: on the day of hCG day ]
    The number of follicle with diameter more than 18mm
  • The number of follicle-2 [ Time Frame: on the fifth day of rhFSH ovarian stimulation ]
    The number of follicle with diameter more than 18mm
  • Number of 2PN oocytes [ Time Frame: Collected on the day of embryo transfer day after three days of ovum picking up. ]
  • Number of metaphase II oocytes [ Time Frame: Collected on the day of embryo transfer day after three days of ovum picking up, which only collected during ICSI cycle. ]
  • Number of transferred embryos [ Time Frame: Collected on the day of embryo transfer day after three days of ovum picking up. ]
  • Number of high quality embryos [ Time Frame: Collected on the day of embryo transfer day after three days of ovum picking up. ]
  • Fresh cycle embryo implantation [ Time Frame: Collected on the day of embryo transfer day after three days of ovum picking up. ]
  • rhFSH administered days and vials; administered total dose of rhFSH (IU) [ Time Frame: Collected on the day of hCG day. ]
  • Serum E2 level [ Time Frame: Collected on the day of hCG day. ]
  • High quality embryos rate [ Time Frame: Collected on the day of embryo transfer day after three days of ovum picking up. ]
  • Fertilization rate [ Time Frame: Collected on the day of embryo transfer day after three days of ovum picking up. ]
  • Fresh cycle embryo implantation rate [ Time Frame: Collected between 28-35 days after embryo transfer. ]
  • Biochemical pregnancy rate [ Time Frame: Collected between 14-16 days after embryo transfer. ]
  • Clinical pregnancy rate [ Time Frame: Collected between 28-35 days after embryo transfer. ]
  • Continuous pregnancy rate [ Time Frame: Collected after 12 weeks of embryo transfer. ]
  • The number of follicle-3 [ Time Frame: on the day of hCG day ]
    The number of follicle with diameter between 14mm and 18mm.
  • The number of follicle-4 [ Time Frame: on the day of hCG day ]
    The number of follicle with diameter less than 14mm
  • Endometrium thickness (mm) [ Time Frame: on the day of hCG ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Recombinant Human Follitropin for Injection Assisted in COH Assisted IVF-ET
Official Title  ICMJE Clinical Study of Recombinant Human Follitropin for Injection Assisted in Controlled Ovarian Hyperstimulation Assisted IVF-ET
Brief Summary The aim of this study was to evaluate the efficacy and safety of domestic recombinant human follicle stimulating hormone (rhFSH) stimulating ovarian to promote follicular development before assisted reproductive technology, which was non-inferiority than that of the imported rhFSH.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Hyperstimulation Syndrome
Intervention  ICMJE
  • Drug: Triptorelin for Injection
    Drugs for IVF-ET (in vitro fertilization and embryo transfer).
    Other Name: Gonadotropin releasing hormone agonists
  • Drug: Recombinant Human Choriogonadotropin alfa Solution for Injection
    Drugs for IVF-ET (in vitro fertilization and embryo transfer).
  • Drug: Progesterone Soft Capsules
    Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Study Arms  ICMJE
  • Experimental: Recombinant Human Follitropin
    Experimental group (domestic rhFSH, powder for injection, 5.5μg (75IU)/vial, initial dose 150-225IU/d, subcutaneous injection, adjust the dose according to ovarian reactivity after 5-7 days of injections, once a day until the HCG trigger day.
    Interventions:
    • Drug: Triptorelin for Injection
    • Drug: Recombinant Human Choriogonadotropin alfa Solution for Injection
    • Drug: Progesterone Soft Capsules
  • Active Comparator: Gonal-F
    Positive control group (imported rhFSH, powder for injection, 5.5μg (75IU)/vial, initial dose 150-225IU/d, subcutaneous injection, adjust the dose according to ovarian reactivity after 5-7 days of injections, once a day until the HCG trigger day.
    Interventions:
    • Drug: Triptorelin for Injection
    • Drug: Recombinant Human Choriogonadotropin alfa Solution for Injection
    • Drug: Progesterone Soft Capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 28, 2017)
252
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age is more than 20 years old and less than 39 years old, married.
  • Applicable for ART controlled ovarian hyperstimulation, such as IVF/ET, ICSI, GIFT, ZIFT and so on.
  • Regular menstrual cycle (25-35 days).
  • 18kg/m2≤BMI<30kg/m2.
  • The level of basic serum FSH <10IU / L in the 2nd-5th days of the menstrual cycle, the luteinizing hormone, estradiol and progesterone levels were normal.
  • The screening period or recent three months of vaginal ultrasound examination showed that the shape of bilateral ovarian and uterine size were normal and 5 ≤ number of basal antral follicle in unilateral ovarian <10, and follicular diameter <10 mm.
  • The in vitro fertilization and embryo transfer (IVF/ET) and (or) intracytoplasmic sperm injection (ICSI) technology were less than three times used prior to the reproductive treatment (provide copies of previous cases).
  • Volunteer to participate and sign informed consent.

Exclusion Criteria:

  • There are high risk of ovarian hyperstimulation syndrome (OHSS), such as the subject who has high response to gonadotropin in the previous ovarian hyperstimulation cycle, polycystic ovary syndrome (PCOS), the subject who has severe OHSS cancellation cycle.
  • Affect the outcome of pregnancy-related diseases (any one): untreated hydrosalpinx, untreated uterine polyps, untreated uterine infection, stage Ⅲ ~ IV endometriosis, ovarian cyst> 4cm , uterine fibroids diameter> 4cm, pelvic benign tumor> 4cm, pituitary tumors and malignant tumors of tissues and organs.
  • The subject has abnormal uterine bleeding.
  • Affect pregnancy-related endocrine and metabolic diseases (any one): hyperprolactinemia, thyroid disease (including hyperthyroidism, hypothyroidism), hyperandrogenism, adrenal dysfunction (including adrenal hyperfunction, adrenal cortical dysfunction).
  • The subject has severe liver and kidney dysfunction, which the levels of serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are 2.5 times higher than the upper limit of normal value, and serum creatinine (Cr) and urea nitrogen (BUN) are 2 times higher than the upper limit of normal value.
  • Severe heart disease, unstable angina pectoris, heart failure grade Ⅲ above, acute myocardial infarction and/or old myocardial infarction, hypertension diagnosed according to the 2010 edition of the Chinese Hypertension Prevention Guidelines.
  • The subject who have contraindications or allergic history for gonadotropin-releasing hormone agonists (GnRH-a), rFSH/human menopausal gonadotropin (hMG), human chorionic gonadotropin (hCG), progesterone drugs.
  • Positive HIV or syphilis.
  • The subject has alcoholism, smoking, drug abuse, bad drug abuse habits.
  • At least one of the spouses has received sperm donor or egg donor or PGD (genetic diagnosis before embryo transfer) and PGS (Preimplantation of embryos before genetic screening)。
  • The subject received clomiphene or gonadotropin therapy within 1 month before screening。
  • The subject was participated in last three months or are participating in other clinical research。
  • Patients with positive serum pregnancy test.
  • The investigators considered the subject inappropriate to be enrolled in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03071172
Other Study ID Numbers  ICMJE GenSci 067 CT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GeneScience Pharmaceuticals Co., Ltd.
Study Sponsor  ICMJE GeneScience Pharmaceuticals Co., Ltd.
Collaborators  ICMJE
  • Peking University Third Hospital
  • The First Affiliated Hospital with Nanjing Medical University
  • Women's Hospital School Of Medicine Zhejiang University
  • Xiangya Hospital of Central South University
  • Sixth Affiliated Hospital, Sun Yat-sen University
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • The First Affiliated Hospital of Anhui Medical University
Investigators  ICMJE
Principal Investigator: Rong Li, Doctor Peking University Third Hospital
PRS Account GeneScience Pharmaceuticals Co., Ltd.
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP