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

GeneScience Pharmaceuticals (GenSci)

Status and phase: Unknown; Phase 3

Conditions: Ovarian Hyperstimulation Syndrome

Treatments: Drug: Recombinant Human Choriogonadotropin alfa Solution for Injection; Drug: Triptorelin for Injection; Drug: Progesterone Soft Capsules

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03071172

GenSci 067 CT

Details and patient eligibility

About

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.

Enrollment: 252 estimated patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 2 patient groups

Recombinant Human Follitropin

Experimental group

Description:

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.

Treatment:

Drug: Recombinant Human Choriogonadotropin alfa Solution for Injection

Drug: Triptorelin for Injection

Drug: Progesterone Soft Capsules

Gonal-F

Active Comparator group

Description:

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.

Treatment:

Drug: Recombinant Human Choriogonadotropin alfa Solution for Injection

Drug: Triptorelin for Injection

Drug: Progesterone Soft Capsules