Identify Effective Doses of LY01021 in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)

NCT07236476 | Active Not Recruiting Phase 2

• 1 other identifier: LY01021/CT-CHN-204
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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). 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

Keywords

Controlled Ovarian Hyperstimulation (COH); Assisted Reproductive Technology (ART)

Outcome Measures

Primary Outcomes (1)

• Inhibition rate of premature LH surge

  From Day 5 to the hCG injection 1 day

Secondary Outcomes (7)

• Number of oocyte retrieved per COH cycle

  On oocyte retrieval 1 day

• 2PN rate.

  16-18 hours (h) after fertilization

• High quality embryo rate.

  3 days after fertilization

• Chemical pregnancy rate.

  13-15 days after transplantation

• Clinical pregnancy rate.

  30-37 days after transplantation

Study Arms (1)

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.;

Drug: LY01021

Interventions

LY01021 DRUG

LY01021 should be taken orally once a day.

LY01021

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: November 19, 2025
• Study Start: October 9, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)