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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.

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.

Condition or disease Intervention/treatment Phase
Ovarian Hyperstimulation Syndrome Drug: Triptorelin for Injection Drug: Recombinant Human Choriogonadotropin alfa Solution for Injection Drug: Progesterone Soft Capsules Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Study of Recombinant Human Follitropin for Injection Assisted in Controlled Ovarian Hyperstimulation Assisted IVF-ET
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : May 2018

Arm Intervention/treatment
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.
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).

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.
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).




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The number of follicle-1 [ Time Frame: on the day of hCG day ]
    The number of follicle with diameter more than 18mm

  2. The number of follicle-2 [ Time Frame: on the fifth day of rhFSH ovarian stimulation ]
    The number of follicle with diameter more than 18mm

  3. Number of 2PN oocytes [ Time Frame: Collected on the day of embryo transfer day after three days of ovum picking up. ]
  4. 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. ]
  5. Number of transferred embryos [ Time Frame: Collected on the day of embryo transfer day after three days of ovum picking up. ]
  6. Number of high quality embryos [ Time Frame: Collected on the day of embryo transfer day after three days of ovum picking up. ]
  7. Fresh cycle embryo implantation [ Time Frame: Collected on the day of embryo transfer day after three days of ovum picking up. ]
  8. rhFSH administered days and vials; administered total dose of rhFSH (IU) [ Time Frame: Collected on the day of hCG day. ]
  9. Serum E2 level [ Time Frame: Collected on the day of hCG day. ]
  10. High quality embryos rate [ Time Frame: Collected on the day of embryo transfer day after three days of ovum picking up. ]
  11. Fertilization rate [ Time Frame: Collected on the day of embryo transfer day after three days of ovum picking up. ]
  12. Fresh cycle embryo implantation rate [ Time Frame: Collected between 28-35 days after embryo transfer. ]
  13. Biochemical pregnancy rate [ Time Frame: Collected between 14-16 days after embryo transfer. ]
  14. Clinical pregnancy rate [ Time Frame: Collected between 28-35 days after embryo transfer. ]
  15. Continuous pregnancy rate [ Time Frame: Collected after 12 weeks of embryo transfer. ]
  16. The number of follicle-3 [ Time Frame: on the day of hCG day ]
    The number of follicle with diameter between 14mm and 18mm.

  17. The number of follicle-4 [ Time Frame: on the day of hCG day ]
    The number of follicle with diameter less than 14mm

  18. Endometrium thickness (mm) [ Time Frame: on the day of hCG ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071172


Contacts
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Contact: Rui Yang 010-82265080 yrjeff@126.com

Locations
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China, Anhui
The first Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
China, Guangdong
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
China, Hunan
Xiangya Hospital Central South University
Changsha, Hunan, China
China, Zhejiang
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
China
Peking University Third Hospital
Beijing, China
Jiangsu Province Hospital
Nanjing, China
Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
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
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Principal Investigator: Rong Li, Doctor Peking University Third Hospital
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Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03071172    
Other Study ID Numbers: GenSci 067 CT
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Triptorelin Pamoate
Chorionic Gonadotropin
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents