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

Ovarian Hyperstimulation Syndrome Clinical Trial

Official title:

Clinical Study of Recombinant Human Follitropin for Injection Assisted in Controlled Ovarian Hyperstimulation Assisted IVF-ET

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03071172
• Other study ID #: GenSci 067 CT
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 20, 2017
• Last updated: February 28, 2017
• Start date: March 2017
• Est. completion date: May 2018

Study information

• Verified date: February 2017
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Rui Yang
• Phone: 010-82265080
• Email: yrjeff[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 252
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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 ? ~ 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 ? 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.

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang
China	The first Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Jiangsu Province Hospital	Nanjing

Sponsors (8)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.	Peking University Third Hospital, 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, The First Affiliated Hospital with Nanjing Medical University, Women's Hospital School Of Medicine Zhejiang University, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of follicle-1	The number of follicle with diameter more than 18mm	on the day of hCG day
Secondary	The number of follicle-2	The number of follicle with diameter more than 18mm	on the fifth day of rhFSH ovarian stimulation
Secondary	Number of 2PN oocytes		Collected on the day of embryo transfer day after three days of ovum picking up.
Secondary	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.
Secondary	Number of transferred embryos		Collected on the day of embryo transfer day after three days of ovum picking up.
Secondary	Number of high quality embryos		Collected on the day of embryo transfer day after three days of ovum picking up.
Secondary	Fresh cycle embryo implantation		Collected on the day of embryo transfer day after three days of ovum picking up.
Secondary	rhFSH administered days and vials; administered total dose of rhFSH (IU)		Collected on the day of hCG day.
Secondary	Serum E2 level		Collected on the day of hCG day.
Secondary	High quality embryos rate		Collected on the day of embryo transfer day after three days of ovum picking up.
Secondary	Fertilization rate		Collected on the day of embryo transfer day after three days of ovum picking up.
Secondary	Fresh cycle embryo implantation rate		Collected between 28-35 days after embryo transfer.
Secondary	Biochemical pregnancy rate		Collected between 14-16 days after embryo transfer.
Secondary	Clinical pregnancy rate		Collected between 28-35 days after embryo transfer.
Secondary	Continuous pregnancy rate		Collected after 12 weeks of embryo transfer.
Secondary	The number of follicle-3	The number of follicle with diameter between 14mm and 18mm.	on the day of hCG day
Secondary	The number of follicle-4	The number of follicle with diameter less than 14mm	on the day of hCG day
Secondary	Endometrium thickness (mm)		on the day of hCG