Clinical Study of Recombinant Human Follitropin for Injection Assisted in COH Assisted IVF-ET
1 other identifier
interventional
252
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2017
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedFirst Posted
Study publicly available on registry
March 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMarch 6, 2017
February 1, 2017
9 months
February 20, 2017
February 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The total number of oocytes obtained during the start-up period
Routine ova harvest to determine the number of obtained oocytes
On the days of ovum picking up (hCG trigger 36-38h)
Secondary Outcomes (18)
The number of follicle-1
on the day of hCG day
The number of follicle-2
on the fifth day of rhFSH ovarian stimulation
Number of 2PN oocytes
Collected on the day of embryo transfer day after three days of ovum picking up.
Number of metaphase II oocytes
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
Collected on the day of embryo transfer day after three days of ovum picking up.
- +13 more secondary outcomes
Study Arms (2)
Recombinant Human Follitropin
EXPERIMENTALExperimental 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.
Gonal-F
ACTIVE COMPARATORPositive 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
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Eligibility Criteria
You may qualify if:
- 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).
- kg/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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changchun GeneScience Pharmaceutical Co., Ltd.lead
- Peking University Third Hospitalcollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- Women's Hospital School Of Medicine Zhejiang Universitycollaborator
- Xiangya Hospital of Central South Universitycollaborator
- Sixth Affiliated Hospital, Sun Yat-sen Universitycollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- The First Affiliated Hospital of Anhui Medical Universitycollaborator
Study Sites (7)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rong Li, Doctor
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2017
First Posted
March 6, 2017
Study Start
March 1, 2017
Primary Completion
December 1, 2017
Study Completion
May 1, 2018
Last Updated
March 6, 2017
Record last verified: 2017-02