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New pill could make IVF easier and more effective

NCT ID NCT07236476

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests an oral drug called LY01021 in about 90 women undergoing IVF or ICSI. The drug aims to prevent premature hormone surges that can disrupt egg retrieval. Researchers are testing three doses to find the best balance of effectiveness and safety, with the goal of improving pregnancy rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY01021 (oral drug to control hormone levels during IVF)
What this could lead to
If successful, this could provide a more convenient oral option to prevent premature ovulation during IVF, potentially improving egg retrieval and pregnancy rates.
What could go wrong
This is an early phase 2 dose-finding study with only 90 participants. The drug may not work better than existing treatments, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 39 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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); * 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Peking University Third Hospital

    Beijing, China

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