Ovarian Hyperstimulation SyndromePhase 3NCT03071172
Clinical Study of Recombinant Human Follitropin for Injection Assisted in COH Assisted IVF-ET
A Phase 3 study testing Triptorelin for Injection, Recombinant Human Choriogonadotropin alfa Solution for Injection and Progesterone Soft Capsules in people with Ovarian Hyperstimulation Syndrome, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 7 sites in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- Triptorelin for Injection, Recombinant Human Choriogonadotropin alfa Solution for Injection and Progesterone Soft Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 7 sitesChina
- Study dates
- Mar 2017to May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking University Third Hospital
Beijing
Xiangya Hospital Central South University
Changsha, Hunan
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang
The first Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Jiangsu Province Hospital
Nanjing
About this study
Official title: Clinical Study of Recombinant Human Follitropin for Injection Assisted in Controlled Ovarian Hyperstimulation Assisted IVF-ET
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
- Ovarian Hyperstimulation Syndrome
- Being tested
- Triptorelin for Injection, Recombinant Human Choriogonadotropin alfa Solution for Injection, Progesterone Soft Capsules
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin for InjectionDrug
Also called Gonadotropin releasing hormone agonists
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Recombinant Human Choriogonadotropin alfa Solution for InjectionDrug
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
Progesterone Soft CapsulesDrug
Drugs for IVF-ET (in vitro fertilization and embryo transfer).
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Follitropin | Experimental | 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. Receives: Drug: Triptorelin for Injection; Drug: Recombinant Human Choriogonadotropin alfa Solution for Injection; Drug: Progesterone Soft Capsules |
| Gonal-F | Active comparator | 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. Receives: Drug: Triptorelin for Injection; Drug: Recombinant Human Choriogonadotropin alfa Solution for Injection; Drug: Progesterone Soft Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total number of oocytes obtained during the start-up period
Routine ova harvest to determine the number of obtained oocytes
Measured: On the days of ovum picking up (hCG trigger 36-38h)
Secondary outcomes (18)
The number of follicle-1
The number of follicle with diameter more than 18mm
Measured: on the day of hCG day
The number of follicle-2
The number of follicle with diameter more than 18mm
Measured: on the fifth day of rhFSH ovarian stimulation
Number of 2PN oocytes
Measured: Collected on the day of embryo transfer day after three days of ovum picking up.
Number of metaphase II oocytes
Measured: 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
Measured: Collected on the day of embryo transfer day after three days of ovum picking up.
Number of high quality embryos
Measured: Collected on the day of embryo transfer day after three days of ovum picking up.
Fresh cycle embryo implantation
Measured: 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)
Measured: Collected on the day of hCG day.
Serum E2 level
Measured: Collected on the day of hCG day.
High quality embryos rate
Measured: Collected on the day of embryo transfer day after three days of ovum picking up.
Fertilization rate
Measured: Collected on the day of embryo transfer day after three days of ovum picking up.
Fresh cycle embryo implantation rate
Measured: Collected between 28-35 days after embryo transfer.
Biochemical pregnancy rate
Measured: Collected between 14-16 days after embryo transfer.
Clinical pregnancy rate
Measured: Collected between 28-35 days after embryo transfer.
Continuous pregnancy rate
Measured: Collected after 12 weeks of embryo transfer.
The number of follicle-3
The number of follicle with diameter between 14mm and 18mm.
Measured: on the day of hCG day
The number of follicle-4
The number of follicle with diameter less than 14mm
Measured: on the day of hCG day
Endometrium thickness (mm)
Measured: on the day of hCG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study startMar 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Hyperstimulation SyndromeStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Investigators
- Rong Li, Doctor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071172
- Sponsor's protocol ID
- GenSci 067 CT
- Status last verified
- Feb 2017
- First submitted
- 20 Feb 2017
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Recombinant Human Follitropin for Injection Assisted in Controlled Ovarian Hyperstimulation Assisted IVF-ET
- ClinicalTrials.gov ID
- NCT03071172
- Acronym / sponsor ID
- GenSci 067 CT
- Conditions
- Ovarian Hyperstimulation Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- 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
- Study start
- Mar 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 6 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Follitropin | Experimental | Drug: Triptorelin for Injection, Drug: Recombinant Human Choriogonadotropin alfa Solution for Injection, Drug: Progesterone Soft CapsulesExperimental 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 comparator | Drug: Triptorelin for Injection, Drug: Recombinant Human Choriogonadotropin alfa Solution for Injection, Drug: Progesterone Soft CapsulesPositive 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. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptorelin for InjectionAlso: Gonadotropin releasing hormone agonistsDrugs for IVF-ET (in vitro fertilization and embryo transfer). | Drug | Gonal-F, Recombinant Human Follitropin |
| Recombinant Human Choriogonadotropin alfa Solution for InjectionDrugs for IVF-ET (in vitro fertilization and embryo transfer). | Drug | Gonal-F, Recombinant Human Follitropin |
| Progesterone Soft CapsulesDrugs for IVF-ET (in vitro fertilization and embryo transfer). | Drug | Gonal-F, Recombinant Human Follitropin |
Primary outcome
The total number of oocytes obtained during the start-up period
Time frame: On the days of ovum picking up (hCG trigger 36-38h)
Routine ova harvest to determine the number of obtained oocytes
18 secondary outcomes
The number of follicle-1
Time frame: on the day of hCG day
The number of follicle-2
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
Time frame: on the day of hCG day
The number of follicle-4
Time frame: on the day of hCG day
Endometrium thickness (mm)
Time frame: on the day of hCG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong Li, Doctor principal investigator
Peking University Third Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triptorelin for Injection, Recombinant Human Choriogonadotropin alfa Solution for Injection and Progesterone Soft Capsules in people with Ovarian Hyperstimulation Syndrome, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui Yang (010-82265080, yrjeff@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total number of oocytes obtained during the start-up period (time frame: On the days of ovum picking up (hCG trigger 36-38h)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.