Female InfertilityPhase 4NCT06921395
Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulation in Infertile Women Undergoing in Vitro Fertilization-embryo Transfer (IVF-ET).
A Phase 4 study testing Fang Le Shu (Follitrope) and Guo Na Fen (Gonal-F) in people with Female Infertility, run by LG Chem at 1 site in China.
Trial summary
The aim of this randomized, open-label, active-controlled, parallel-group, multicenter, phase IV study is to assess the efficacy and safety of Fang Le Shu versus Guo Na Fen used for controlled ovarian stimulation in infertile women undergoing In Vitro Fertilization-Embryo Transfer. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- Fang Le Shu (Follitrope) and Guo Na Fen (Gonal-F)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Is pre-menopausal female aged ≥20 to <40 years.
- Has regular menstrual cycles of ≥25 to ≤35 days.
- Has Normal baseline serum FSH, LH, E2, P4.
- Is able to voluntarily sign the informed consent form (ICF).
- Has history of infertility for at least 1 year before the day of randomization; however, subjects with confirmed diagnosis of infertility are eligible without fulfilling the 1-year requirement.
Who cannot join
- Has any known clinically significant major systemic disease, or endocrine or metabolic abnormalities with the exception of controlled thyroid function disease.
- Has body mass index (BMI) of >30 kg/m2.
- Has clinically significant abnormalities of the uterus, ovary, or appendix prior to the day of randomization
- Has history of surgeries that may affect oocyte retrieval or pregnancy outcome, such as surgical resection of uterine mediastinum, fibroids, or cysts (however, patients who received polypectomy are allowed to enroll).
- Has history of severe ovarian hyperstimulation syndrome (OHSS) defined as Grade 4 or higher.
- Poor ovarian reponder according to Bologna criteria
Show all 12Show fewer
- Has plans to donate oocyte or recieve embryo from another women or undergo preimplantation genetic testing(PGT)
- Has history of three or more failures in previous IVF cycles
- Has history of recurrent miscarriage
- Has known current active pelvic inflammatory disease.
- Is currently breastfeeding.
- Has a contraindication to pregnancy that would preclude participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV, Prospective, Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Evaluate Efficacy and Safety of Fang Le Shu (Recombinant FSH) Versus Guo Na Fen Used for Controlled Ovarian Stimulation in Infertile Women Undergoing In Vitro Fertilization-Embryo Transfer.
The aim of this randomized, open-label, active-controlled, parallel-group, multicenter, phase IV study is to assess the efficacy and safety of Fang Le Shu versus Guo Na Fen used for controlled ovarian stimulation in infertile women undergoing In Vitro Fertilization-Embryo Transfer.
- Conditions
- Female Infertility
- Being tested
- Fang Le Shu (Follitrope), Guo Na Fen (Gonal-F)
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fang Le Shu (Follitrope)Drug
rFSH 150 IU, 225 IU, 300 IU per syringe
Guo Na Fen (Gonal-F)Drug
rFSH 450 IU per pen
| Study group | Role | What they receive |
|---|---|---|
| Fang Le Shu | Experimental | Fang Le Shu Receives: Drug: Fang Le Shu (Follitrope) |
| Guo Na Fen | Active comparator | Guo Na Fen Receives: Drug: Guo Na Fen (Gonal-F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
Measured: 36 ± 3 hours after HGC trigger
Secondary outcomes (6)
High quality embryo rate
Measured: 3 days after oocyte retrieval
Biochemical pregnancy rate
Measured: 14 days after embryo transfer
Clinical pregnancy rate
Measured: 5 weeks after embryo transfer
Ongoing pregnancy rate
Measured: 10 weeks after embryo transfer
Miscarriage rate
Measured: 28 weeks of gestation
Live birth rate
Measured: 40 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start15 Feb 2025
- Primary completion26 Dec 2025
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921395
- Sponsor's protocol ID
- LG-FSCL006
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Prospective, Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Evaluate Efficacy and Safety of Fang Le Shu (Recombinant FSH) Versus Guo Na Fen Used for Controlled Ovarian Stimulation in Infertile Women Undergoing In Vitro Fertilization-Embryo Transfer.
- ClinicalTrials.gov ID
- NCT06921395
- Acronym / sponsor ID
- LG-FSCL006
- Conditions
- Female Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 26 Dec 2025 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Apr 2025 (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 randomized, open-label, active-controlled, parallel-group, multicenter, phase IV study is to assess the efficacy and safety of Fang Le Shu versus Guo Na Fen used for controlled ovarian stimulation in infertile women undergoing In Vitro Fertilization-Embryo Transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fang Le Shu | Experimental | Drug: Fang Le Shu (Follitrope)Fang Le Shu |
| Guo Na Fen | Active comparator | Drug: Guo Na Fen (Gonal-F)Guo Na Fen |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Is pre-menopausal female aged ≥20 to <40 years.
- Has regular menstrual cycles of ≥25 to ≤35 days.
- Has Normal baseline serum FSH, LH, E2, P4.
- Is able to voluntarily sign the informed consent form (ICF).
- Has history of infertility for at least 1 year before the day of randomization; however, subjects with confirmed diagnosis of infertility are eligible without fulfilling the 1-year requirement.
Key exclusion criteria (12 listed)
- Has any known clinically significant major systemic disease, or endocrine or metabolic abnormalities with the exception of controlled thyroid function disease.
- Has body mass index (BMI) of >30 kg/m2.
- Has clinically significant abnormalities of the uterus, ovary, or appendix prior to the day of randomization
- Has history of surgeries that may affect oocyte retrieval or pregnancy outcome, such as surgical resection of uterine mediastinum, fibroids, or cysts (however, patients who received polypectomy are allowed to enroll).
- Has history of severe ovarian hyperstimulation syndrome (OHSS) defined as Grade 4 or higher.
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 |
|---|---|---|
| Fang Le Shu (Follitrope)rFSH 150 IU, 225 IU, 300 IU per syringe | Drug | Fang Le Shu |
| Guo Na Fen (Gonal-F)rFSH 450 IU per pen | Drug | Guo Na Fen |
Primary outcome
Number of oocytes retrieved
Time frame: 36 ± 3 hours after HGC trigger
6 secondary outcomes
High quality embryo rate
Time frame: 3 days after oocyte retrieval
Biochemical pregnancy rate
Time frame: 14 days after embryo transfer
Clinical pregnancy rate
Time frame: 5 weeks after embryo transfer
Ongoing pregnancy rate
Time frame: 10 weeks after embryo transfer
Miscarriage rate
Time frame: 28 weeks of gestation
Live birth rate
Time frame: 40 weeks of gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Female Infertility
RecruitingObservational study
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Acute Ovarian Failure, Infertility
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
Not yet recruitingObservational study
Low TGF-β and Embryo Implantation in the Context of Assisted Reproductive Technology: Confirmation of a Biomarker Predictive of Success and Characterization of the Immune Microenvironment.
Infertility, Female, Pregnancy Related
RecruitingObservational study
The Effects of Uterine Fibroids on Pregnancy in Women
Female Infertility, Uterine Fibroid
Not yet recruiting
Intra-ovarian CAPA-IVM vs Standard IVM
Infertility (IVF Patients), Infertility
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fang Le Shu (Follitrope) and Guo Na Fen (Gonal-F) in people with Female Infertility, run by LG Chem 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 5 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number of oocytes retrieved (time frame: 36 ± 3 hours after HGC trigger). 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 2 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.