Assisted ReproductionPhase 2NCT07236476
Identify Effective Doses of LY01021 in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)
A Phase 2 study testing LY01021 in people with Assisted Reproduction, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This is a multicentre, open-label, dose-finding, phase 2 study that will recruit approximately 90 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI). Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Assisted Reproduction
- What is being tested?
- LY01021
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2024to 31 Dec 2025
- Phase
- Phase 2
- 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
- Informed consent of subjects and their spouses;
- Married infertile female subjects aged 20 to 40 years (40 years exclusive) with indications for in vitro fertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI);
- Weight 45Kg ~ 80Kg (both inclusive), and body mass index (BMI) 19.0 ~ 28.0kg/m2;
- Regular menstrual cycle (24 ~ 35 days, both inclusive) for the last 3 months prior to screening;
- Anticipated normal ovarian response;
- Willingness of the subject to undergo fresh cycle transfer with one or two embryos at a time in the first IVF-ET cycle；
- Normal cervical cytology results (TCT) or with limited clinically significance within 6 months prior to screening; or subjects with atypical squamous cells of undetermined significance (ASC-US) of TCT tested negative for high-risk types of human papillomavirus (HPV).
Who cannot join
- Prior to screening, individuals underwent three or more IVF/ICSI-ET COH cycles without achieving clinical pregnancy；
- Previous IVF/ ICSI failure due to sperm/fertilization problems/low fertilization rate(<30%) and no improvement in related medical condition;
- Subjects with more than 2 times of spontaneous abortion;
- Subjects at high risk of OHSS, judged by the investigator according to the Golan classification (e.g., those with moderate to severe OHSS during previous COH cycles, polycystic ovary syndrome (PCOS), or with previous cancelled COH cycles due to OHSS);
- Subjects with low ovarian function;
- Any pregnancy that occurred within 3 months prior to screening;
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- Unexplained abnormal vaginal bleeding within 6 months prior to screening;
- Subjects with serious infection, severe trauma or major surgical procedure within 6 months prior to screening.
- ALT and AST levels at the screening visit or the start of ovarian stimulation were more than twice the upper limit of normal;
- Positive serum β-hCG test at the screening visit or the start day of ovarian stimulation;
- Past medical history or gynecological ultrasound indicates clinically significant conditions;
- Any disease or symptom that can affect systemic function or may affect the absorption, accumulation, metabolism, or excretion of the test drug (e.g., chronic intestinal diseases, Crohn's disease, ulcerative colitis).
- Major systemic diseases, endocrine or metabolic abnormalities;
- Thromboembolic diseases or a history of thromboembolic diseases;
- The subject or her spouse or both of them carry a chromosomal abnormality, or suffer from a known monogenic hereditary disease or a severe disease with genetic susceptibility requiring pre-implantation genetic testing (excluding chromosomal polymorphisms);
- Malignant tumor or history of malignant tumor (except basal cell or squamous cell skin cancer, papillary thyroid carcinoma, in situ cancer );
- Use of fertility regulators within 1 month prior to ovarian stimulation, such as clomiphene citrate, letrozole, gonadotropins (Gn), hormonal drugs (including oral contraceptives, estrogens, progestogens, etc.) bromocriptine, etc..
- Subjects who have used strong inducers/inhibitors of cytochrome P450 3A4 (CYP3A4), strong inducers/inhibitors of P-glycoprotein (P-gp), or gastric acid secretion inhibitors within 2 weeks or 5 half-lives (whichever is longer) before the first administration of LY01021;
- Any other reasons deemed by the researcher as unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Open-label, Dose-finding, Phase 2 Study to Investigate the Efficacy, and Safety of Different Doses of LY01021 in Controlled Ovarian Hyperstimulation(COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)
This is a multicentre, open-label, dose-finding, phase 2 study that will recruit approximately 90 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI). Three LY01021 dose groups of 40 mg QD, 30 mg QD, and 20 mg QD will be included, with not exceed 45 subjects in each group to investigate the efficacy and safety.
- Conditions
- Assisted Reproduction
- Being tested
- LY01021
- Keywords
- Controlled Ovarian Hyperstimulation (COH), Assisted Reproductive Technology (ART)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY01021Drug
LY01021 should be taken orally once a day.
| Study group | Role | What they receive |
|---|---|---|
| LY01021 | Experimental | Treatment group 40mg: oral LY01021; 40mg QD p.o.; Treatment group 30mg: oral LY01021; 30mg QD p.o.; Treatment group 20mg: oral LY01021; 20mg QD p.o.; Receives: Drug: LY01021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition rate of premature LH surge
Measured: From Day 5 to the hCG injection 1 day
Secondary outcomes (7)
Number of oocyte retrieved per COH cycle
Measured: On oocyte retrieval 1 day
2PN rate.
Measured: 16-18 hours (h) after fertilization
High quality embryo rate.
Measured: 3 days after fertilization
Chemical pregnancy rate.
Measured: 13-15 days after transplantation
Clinical pregnancy rate.
Measured: 30-37 days after transplantation
Persistent pregnancy rate.
Measured: 70-84 days after transplantation
Adverse events.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start9 Oct 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted ReproductionStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236476
- Sponsor's protocol ID
- LY01021/CT-CHN-204
- Status last verified
- Nov 2025
- First submitted
- 27 Aug 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label, Dose-finding, Phase 2 Study to Investigate the Efficacy, and Safety of Different Doses of LY01021 in Controlled Ovarian Hyperstimulation(COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)
- ClinicalTrials.gov ID
- NCT07236476
- Acronym / sponsor ID
- LY01021/CT-CHN-204
- Conditions
- Assisted Reproduction
- Keywords
- Controlled Ovarian Hyperstimulation (COH), Assisted Reproductive Technology (ART)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Nov 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.
This is a multicentre, open-label, dose-finding, phase 2 study that will recruit approximately 90 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI). Three LY01021 dose groups of 40 mg QD, 30 mg QD, and 20 mg QD will be included, with not exceed 45 subjects in each group to investigate the efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY01021 | Experimental | Drug: LY01021Treatment group 40mg: oral LY01021; 40mg QD p.o.; Treatment group 30mg: oral LY01021; 30mg QD p.o.; Treatment group 20mg: oral LY01021; 20mg QD p.o.; |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Informed consent of subjects and their spouses;
- Married infertile female subjects aged 20 to 40 years (40 years exclusive) with indications for in vitro fertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI);
- Weight 45Kg ~ 80Kg (both inclusive), and body mass index (BMI) 19.0 ~ 28.0kg/m2;
- Regular menstrual cycle (24 ~ 35 days, both inclusive) for the last 3 months prior to screening;
- Anticipated normal ovarian response;
Key exclusion criteria (19 listed)
- Prior to screening, individuals underwent three or more IVF/ICSI-ET COH cycles without achieving clinical pregnancy；
- Previous IVF/ ICSI failure due to sperm/fertilization problems/low fertilization rate(<30%) and no improvement in related medical condition;
- Subjects with more than 2 times of spontaneous abortion;
- Subjects at high risk of OHSS, judged by the investigator according to the Golan classification (e.g., those with moderate to severe OHSS during previous COH cycles, polycystic ovary syndrome (PCOS), or with previous cancelled COH cycles due to OHSS);
- Subjects with low ovarian function;
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 |
|---|---|---|
| LY01021LY01021 should be taken orally once a day. | Drug | LY01021 |
Primary outcome
Inhibition rate of premature LH surge
Time frame: From Day 5 to the hCG injection 1 day
7 secondary outcomes
Number of oocyte retrieved per COH cycle
Time frame: On oocyte retrieval 1 day
2PN rate.
Time frame: 16-18 hours (h) after fertilization
High quality embryo rate.
Time frame: 3 days after fertilization
Chemical pregnancy rate.
Time frame: 13-15 days after transplantation
Clinical pregnancy rate.
Time frame: 30-37 days after transplantation
Persistent pregnancy rate.
Time frame: 70-84 days after transplantation
Adverse events.
Time frame: Through study completion, an average of 3 months
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 19 Nov 2025.
- 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.
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 2 study testing LY01021 in people with Assisted Reproduction, run by Luye Pharma Group 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 7 inclusion and 19 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 19 Nov 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Inhibition rate of premature LH surge (time frame: From Day 5 to the hCG injection 1 day). 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 19 Nov 2025.