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

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

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

Interventional

Enrollment (Estimated)

66

Phase

  • 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 Locations

    • 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

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
Intervention / Treatment
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
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.
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

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

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.

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)

July 1, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

September 3, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

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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