A Randomized Controlled Study on the Effect of MRJPs on Improving Ovarian Function and Endometrial Receptivity

NCT ID: NCT07246733

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2028-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will assess the effects of the rose tablet candies produced by MRJPs on the subjects, evaluate the role of MRJPs in the ovarian function and endometrial receptivity of women, reveal the potential application value of MRJPs in reproductive health, and determine its safety and effectiveness.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Ovarian reserve function and endometrial receptivity are important components of female fertility. Ovarian function is regulated by various factors, including genetics, environment, oxidative stress, inflammatory response, and endocrine regulation. Decline in ovarian function is an important factor leading to decreased fertility and perimenopausal symptoms. Endometrial receptivity refers to the ability of the endometrium to accept embryos, that is, the ability to allow the embryo to undergo processes such as positioning, adhesion, and invasion in the uterine cavity. Endometrial receptivity is a key factor for successful embryo implantation.

Royal jelly, as a natural biological nutrient, is rich in proteins, lipids, carbohydrates, vitamins, and various bioactive components. It shows various potential health benefits in promoting growth and development, regulating immune function, and antioxidation. The main active component of royal jelly - royal jelly major protein (MRJPs), has been proven to have significant effects in cell proliferation, anti-inflammatory, antioxidant, and endocrine regulation. Studies have shown that MRJPs can significantly increase serum estradiol and progesterone levels, reduce follicle-stimulating hormone and luteinizing hormone contents, increase the expression levels of estrogen receptor genes and progesterone receptor genes, increase the average thickness of the endometrium, thereby improving ovarian function and enhancing endometrial receptivity.

The ELELADY Royal Jelly Major Protein Rose Pressed Tablet Candy (Food Production License Number:SC10644070506130) has two major patent technologies. The specific detection patent technology can quickly detect the freshness of royal jelly to ensure the quality of raw materials, and the green ultrafiltration membrane separation patent technology can obtain high-purity freeze-dried powder of royal jelly major protein and bee royal jelly small molecule active essence liquid that can be stored at room temperature.

This study intends to adopt a scientific and rigorous experimental design, through the combination of clinical trials and basic experiments, strictly following ethical principles, to ensure the rights and safety of the subjects, and at the same time, adopt scientific data management and analysis methods to ensure the reliability of the research results. The conduct of this study will help reveal the potential application value of MRJPs in reproductive health, provide scientific basis for its application in regulating ovarian function and endometrial receptivity and the prevention and treatment of related diseases, and also provide new ideas and research directions for the development and application of natural products in reproductive medicine.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diminished Ovarian Reserve (DOR) Thin Endometrium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

Oral MRJPs Candy (500 mg per tablet, containing 70% MRJPs freeze-dried powder + 20% sodium cellulose + 10% microcrystalline cellulose, with an appropriate amount of arabinose), taken twice a day, 1 tablet each time, for a total of 1 menstrual cycle

Group Type EXPERIMENTAL

Oral MRJPs Candy

Intervention Type DIETARY_SUPPLEMENT

500 mg per tablet, containing 70% MRJPs freeze-dried powder + 20% sodium cellulose + 10% microcrystalline cellulose, with an appropriate amount of arabinose, taken twice a day, 1 tablet each time, for a total of 1 menstrual cycle in the control group.

Control group

Oral placebo candy (500 mg per tablet, containing 70% whey protein powder + 20% sodium cellulose + 10% microcrystalline cellulose, with appropriate amount of arabinose), taken twice a day, 1 tablet each time, for a total of 1 menstrual cycle in the control group.

Group Type PLACEBO_COMPARATOR

Oral placebo candy

Intervention Type DIETARY_SUPPLEMENT

500 mg per tablet, containing 70% whey protein powder + 20% sodium cellulose + 10% microcrystalline cellulose, with appropriate amount of arabinose, taken twice a day, 1 tablet each time, for a total of 1 menstrual cycle in the control group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral MRJPs Candy

500 mg per tablet, containing 70% MRJPs freeze-dried powder + 20% sodium cellulose + 10% microcrystalline cellulose, with an appropriate amount of arabinose, taken twice a day, 1 tablet each time, for a total of 1 menstrual cycle in the control group.

Intervention Type DIETARY_SUPPLEMENT

Oral placebo candy

500 mg per tablet, containing 70% whey protein powder + 20% sodium cellulose + 10% microcrystalline cellulose, with appropriate amount of arabinose, taken twice a day, 1 tablet each time, for a total of 1 menstrual cycle in the control group.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Fertile women, aged 20 to 45 years old, with regular and normal menstrual cycles.

Exclusion Criteria

* ① Allergic to royal jelly or its components; ② Suffering from severe chronic diseases or endocrine system disorders; ③ Pregnant or breastfeeding; ④ Undergoing hormone replacement therapy (HRT) within the last month
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiaolin Wu

Role: CONTACT

+86-579-19548878600

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

XIaolin Wu

Role: primary

+86 19548878600

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY-2025-121

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.