Clinical Study of Recombinant Human Follitropin for Injection Assisted in COH Assisted IVF-ET
NCT ID: NCT03071172
Last Updated: 2017-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
252 participants
INTERVENTIONAL
2017-03-31
2018-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference
NCT06091436
Randomized Controlled Study of Comparing Follitrope Versus Gonal-f in Chinese Infertility Women.
NCT03506243
Effect of Recombinant Human Growth Hormone Injection on the Clinical Outcome of POR in Patients Undergoing IVF/ET
NCT02801591
Gonadotrophin Releasing Hormone Agonist Addition for Luteal Support in In-vitro Fertilization and Embryo Transfer Cycles
NCT02908438
Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)
NCT00702546
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Triptorelin for Injection
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Recombinant Human Choriogonadotropin alfa Solution for Injection
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Progesterone Soft Capsules
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
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.
Triptorelin for Injection
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Recombinant Human Choriogonadotropin alfa Solution for Injection
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Progesterone Soft Capsules
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Triptorelin for Injection
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Recombinant Human Choriogonadotropin alfa Solution for Injection
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Progesterone Soft Capsules
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
20 Years
39 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University Third Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Women's Hospital School Of Medicine Zhejiang University
OTHER
Xiangya Hospital of Central South University
OTHER
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rong Li, Doctor
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The first Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Peking University Third Hospital
Beijing, , China
Jiangsu Province Hospital
Nanjing, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GenSci 067 CT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.