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

November 20, 2025 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Yiwu, Zhejiang, China, 322000
        • Recruiting
        • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Dietary supplement: 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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anti-Müllerian hormone
Time Frame: From enrollment to the end of treatment at 1 month
Ovarian function testing indicator
From enrollment to the end of treatment at 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sex hormone levels
Time Frame: From enrollment to the end of treatment at 1 month
Basic follicle-stimulating hormone
From enrollment to the end of treatment at 1 month
Endometrial receptivity
Time Frame: From enrollment to the end of treatment at 1 month
Ultrasound examination during the luteal phase to assess endometrial receptivity
From enrollment to the end of treatment at 1 month
Sex hormone levels
Time Frame: From enrollment to the end of treatment at 1 month
Basic luteinizing hormone
From enrollment to the end of treatment at 1 month
Sex hormone levels
Time Frame: From enrollment to the end of treatment at 1 month
Basal estradiol hormone
From enrollment to the end of treatment at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY-2025-121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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