Infertility, FemalePhase 3NCT03506243
Randomized Controlled Study of Comparing Follitrope Versus Gonal-f in Chinese Infertility Women.
A Phase 3 study testing Follitrope PFS and Gonal-f pen in people with Infertility, Female, run by Hangzhou YuYuan Bioscience Technology Co., Ltd. at 1 site in China.
Trial summary
This study is for evaluating safety and efficacy of Recombinant human follicle-stimulating hormone (Follitrope) injection compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Follitrope PFS and Gonal-f pen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to May 2017
- 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
- Infertile adult women between 20 and 39 years at screening.
- Infertile adult women with regular menstrual cycles of 25 to 35 days at screening.
- Normal basal serum FSH, LH, E2, and P levels at the early follicular phase at screening.
- If the cause of infertility is due to following reasons:
- Tubal factor
- Unknown reason
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- Male infertility
- Combined factors
- Willing to give voluntary written informed consent.
Who cannot join
- Patients with a clinically significant systemic disease, endocrine or metabolic abnormalities.
- Body Mass Index > 30 (BMI; kg/m2) at screening.
- Patients with a uterine (fibroids (diameter greater than or equal to 2CM endometrium), endometrial polyps, intrauterine adhesions, uterine malformations), ovaries (polycystic ovary, ovarian cysts) or adnexa (hydrosalpinx) abnormalities at screening.
- patients with uterine, ovarian surgery treatment
- Patients who experienced of severe ovarian hyperstimulation symptoms (OHSS) in previous IVF cycles.
- Patients who have shown poor response with gonadotropin hormone therapy.
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- At least two of the following three features must be present:
- ① A previous POR(≤3 retrieved oocyte with a conventional stimulation protocol)
- ② An abnormal ovarian reserve test (i.e. AFC < 5 follicles) at screening.
- Abnormal metrorrhagia due to unknown reason at screening.
- At least one of husband and wife to accept donor sperm or donor eggs or PGD subject
- Subjects who are positive for HIV or syphilis at screening.
- Significant known psychiatric disorder or who unable to understand the objectives and methods, etc. of this clinical trial and unable to comply with the study procedures at screening.
- Presence of elicit alcohol, smoke or drug abuse habit at screening.
- History of hypersensitivity to rhFSH or other pharmaceutical excipients of this drug.
- Participation in any other clinical trial after registering for this study or have participated in another clinical study within 3 month before randomization in this study.
- History of tumors of the ovary, breast, uterus, hypothalamus or pituary gland.
- More than 3 times previously consecutive unsuccessful in vitro fertilization cycles at screening.
- Subjects with no clomiphene citrate or gonadotropin treatment within 1 month before randomization.
- Positive serum pregnancy test at screening.
- 14 ± 2 days after the demotion, results of subjects who does not belong to the standard (antral follicle size ≥10mm)
Trial locations and contacts
1 site in 1 country.
China1 site
Hangzhou Yuyuan Bioscience Technology Co.,Ltd
Hangzhou, Zhejiang, 310018
About this study
Official title: A Phase III, Multicenter, Blinded, Randomized, Controlled, Parallel, Comparative Study for the Evaluation of Safety and Efficacy of rhFSH Injection Compared With Gonal-F® Pen Undergoing Controlled Ovarian Hyper Stimulation IVF-ET
This study is for evaluating safety and efficacy of Recombinant human follicle-stimulating hormone (Follitrope) injection compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China
Read the detailed description
This is a Phase 3, multicenter, blinded, randomized, controlled, parallel, comparative study for the evaluation of safety and efficacy of Recombinant human follicle-stimulating hormone injection (Follitrope) compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China.
- Conditions
- Infertility, Female
- Being tested
- Follitrope PFS, Gonal-f pen
- Keywords
- IVF, rhFSH
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitrope PFSBiological
Follitrope PFS
Gonal-f penBiological
Gonal-f pen
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Follitrope PFS Receives: Biological: Follitrope PFS |
| Control group | Active comparator | Gonal-F pen Receives: Biological: Gonal-f pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total number of oocytes retrieved
The total number of oocytes retrieved
Measured: 15 days after using FSH
Secondary outcomes (5)
Total dose and duration of FSH administration
Total dose and duration of FSH administration
Measured: Throughout the study completion (e.g., 10 days)
No. of follicles with diameter equal or more than 14 mm on hGH injection day
No. of follicles with diameter equal or more than 14 mm on hGH injection day
Measured: The day of hGH injection
No. of embryo transferred
No. of embryo transferred
Measured: 3 days after the ovum pick-up
Clinical pregnancy rate
Clinical pregnancy rate by g-sac
Measured: 5 weeks after the embryo transfer
On-going pregnancy rate
On-going pregnancy rate by fetal heart-beat
Measured: 10 weeks after the embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study startApr 2015
- Primary completionSep 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou YuYuan Bioscience Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- LG Chem
- Responsible party
- Sponsor
- Investigators
- Ying Pu Sun, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506243
- Sponsor's protocol ID
- TG1409CPL
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Blinded, Randomized, Controlled, Parallel, Comparative Study for the Evaluation of Safety and Efficacy of rhFSH Injection Compared With Gonal-F® Pen Undergoing Controlled Ovarian Hyper Stimulation IVF-ET
- ClinicalTrials.gov ID
- NCT03506243
- Acronym / sponsor ID
- TG1409CPL
- Conditions
- Infertility, Female
- Keywords
- IVF, rhFSH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Hangzhou YuYuan Bioscience Technology Co., Ltd.University, hospital or other
- Collaborators
- LG Chem
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Apr 2018 (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.
This study is for evaluating safety and efficacy of Recombinant human follicle-stimulating hormone (Follitrope) injection compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China
Detailed description
This is a Phase 3, multicenter, blinded, randomized, controlled, parallel, comparative study for the evaluation of safety and efficacy of Recombinant human follicle-stimulating hormone injection (Follitrope) compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Biological: Follitrope PFSFollitrope PFS |
| Control group | Active comparator | Biological: Gonal-f penGonal-F pen |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Infertile adult women between 20 and 39 years at screening.
- Infertile adult women with regular menstrual cycles of 25 to 35 days at screening.
- Normal basal serum FSH, LH, E2, and P levels at the early follicular phase at screening.
- If the cause of infertility is due to following reasons:
- Willing to give voluntary written informed consent.
Key exclusion criteria (21 listed)
- Patients with a clinically significant systemic disease, endocrine or metabolic abnormalities.
- Body Mass Index > 30 (BMI; kg/m2) at screening.
- Patients with a uterine (fibroids (diameter greater than or equal to 2CM endometrium), endometrial polyps, intrauterine adhesions, uterine malformations), ovaries (polycystic ovary, ovarian cysts) or adnexa (hydrosalpinx) abnormalities at screening.
- patients with uterine, ovarian surgery treatment
- Patients who experienced of severe ovarian hyperstimulation symptoms (OHSS) in previous IVF cycles.
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 |
|---|---|---|
| Follitrope PFSFollitrope PFS | Biological | Test group |
| Gonal-f penGonal-f pen | Biological | Control group |
Primary outcome
The total number of oocytes retrieved
Time frame: 15 days after using FSH
The total number of oocytes retrieved
5 secondary outcomes
Total dose and duration of FSH administration
Time frame: Throughout the study completion (e.g., 10 days)
No. of follicles with diameter equal or more than 14 mm on hGH injection day
Time frame: The day of hGH injection
No. of embryo transferred
Time frame: 3 days after the ovum pick-up
Clinical pregnancy rate
Time frame: 5 weeks after the embryo transfer
On-going pregnancy rate
Time frame: 10 weeks after the embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Ying Pu Sun principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Follitrope PFS and Gonal-f pen in people with Infertility, Female, run by Hangzhou YuYuan Bioscience Technology Co., Ltd. at 1 site 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 9 inclusion and 21 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: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total number of oocytes retrieved (time frame: 15 days after using FSH). 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 24 Apr 2018.