Status unknownNCT03071172Updated Mar 6, 2017

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

A Phase 3 interventional study of Triptorelin for Injection and Recombinant Human Choriogonadotropin alfa Solution for Injection in Ovarian Hyperstimulation Syndrome, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Status unknown at 7 sites in China. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2017-03-06.

Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 3
Study type: Interventional
Enrollment: 252
Allocation: Randomized
Ages: 20 Years to 39 Years
Sex: Female

Study 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.

Conditions studied

Ovarian Hyperstimulation Syndrome

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Ovarian Hyperstimulation Syndrome 64

In context

Ovarian Hyperstimulation Syndrome

64 studies on the registry are indexed under Ovarian Hyperstimulation Syndrome; 3 are open to participants now.

This study's planned enrollment of 252 is above the median of 100 across 48 interventional studies indexed under Ovarian Hyperstimulation Syndrome.

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Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 108 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 39 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 252 participants (estimated)

Study arms

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 · Drug: Recombinant Human Choriogonadotropin alfa Solution for Injection · Drug: Progesterone Soft Capsules
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 · Drug: Recombinant Human Choriogonadotropin alfa Solution for Injection · Drug: Progesterone Soft Capsules

Interventions

DrugTriptorelin for Injection
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Also known as: Gonadotropin releasing hormone agonists
DrugRecombinant Human Choriogonadotropin alfa Solution for Injection
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
DrugProgesterone Soft Capsules
Drugs for IVF-ET (in vitro fertilization and embryo transfer).

What researchers measure

Primary outcomes

The total number of oocytes obtained during the start-up period
Routine ova harvest to determine the number of obtained oocytes
Time frame: On the days of ovum picking up (hCG trigger 36-38h)

Secondary outcomes

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

Study locations

7 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03071172
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
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
Responsible party: Sponsor
First posted: Mar 6, 2017
Start date: Mar 2017 (estimated)
Primary completion: Dec 2017 (estimated)
Completion: May 2018 (estimated)
Last update: Mar 6, 2017

Study contacts

Rui Yang

Contact

yrjeff@126.com

010-82265080

Rong Li, Doctor

principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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