Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight/Obese PCOS Patients

November 29, 2024 updated by: RenJi Hospital

A Randomized Controlled Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight/Obese Polycystic Ovary Syndrome Patients

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility and is characterized by ovulatory dysfunction, increased androgens, and polycystic ovaries. The goal of this randomized control study is to compare the efficacy between acupuncture and metformin both with intensive lifestyle intervention for overweight /obese PCOS patients in weight and pregnancy rates improvement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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

A randomized control study is designed to compare the efficacy of acupuncture and metformin with intensive lifestyle intervention for overweight /obese PCOS patients in weight and pregnancy rate improvement. 92 patients will be enrolled from Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine and will be divided into 2 groups: acupuncture+ intensive lifestyle intervention group and metformin + intensive lifestyle intervention group. Each group used a specific treatment (shown as the group name) for 8 weeks. In this study, the role of acupuncture in improving weight control and pregnancy rate in overweight/obese PCOS patients will be evaluated, the safety and efficacy of acupuncture as well as metabolic measurements. Molecular targets and models for predicting the sensitivity and prognosis of acupuncture treatment, as well as in-depth research on the molecular mechanism of acupuncture in treating PCOS, have a guiding significance and promote the modernization of traditional 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.
92

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
      • Shanghai, China, 200127
        • Renji Hospital, School of Medicine, Shanghai Jiaotong University

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

No

Description

Inclusion Criteria:

  1. Diagnosis of PCOS according to the 2003 Rotterdam criteria with at least two of the following three symptoms: clinical and/or biochemical signs of hyperandrogenism (hirsutism or acne), oligomerism/amenorrhea, and/or polycystic ovaries (PCOS). Biochemical hyperandrogenism is defined as total testosterone > 2.6 nmol/L or free androgen index >7. Hirsutism is defined as an FG score ≥7. Oligomenorrhea is defined as menstrual bleeding > 35 days between menstrual periods in the past year, < 8 menstrual bleeding. Amenorrhea is < 3 cycles per year. PCO is defined by transvaginal ultrasound, where one or both ovaries ≥ 12 follicles 2-9 mm and/or ovarian volume ≥ 10 mL. Other endocrine disorders such as atypical congenital adrenal hyperplasia (17-hydroxyprogesterone <3 nmol/L), androgen-secreting tumors, or suspected Cushing syndrome are excluded.
  2. Age from ≥ 20 years old (legal age of marriage) to ≤ 40 years old
  3. PCOS patients: BMI ≥ 25 to ≤40kg/m2.
  4. Willing to sign the consent form.

Exclusion Criteria:

  1. History of severe heart disease, hematologic disease;
  2. Known kidney disease (creatinine clearance rate <45mL/min), liver function ALT, AST more than 3 times the normal value, autoimmune disease or cancer;
  3. Any acute disease that has the potential to alter renal function or cause tissue hypoxia;
  4. Type I diabetes mellitus;
  5. Medication within 12 weeks (hormonal drugs, antidepressants, other anti-diabetic drugs, contraceptives, ovulation induction drugs or other drugs that affect the trial in the judgment of the investigator);
  6. Allergy to metformin hydrochloride or any excipients;
  7. Blood pressure > 160/100 mm Hg;
  8. Pregnancy or breastfeeding in the past three months;
  9. No history of acupuncture treatment within 2 months;
  10. Alcohol dependence
  11. Persons with disabilities with language impairment or reduced ability to understand the information provided;
  12. Those who have participated in other clinical studies within three months;
  13. The man clearly diagnoses infertility-related diseases and factors.

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: None (Open Label)

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: acupuncture+ intensive lifestyle intervention
8 weeks acupuncture+ intensive lifestyle intervention
Other: Acupuncture+lifestyle intervention
8 weeks Acupuncture treatment for 2-3 times/week, 30min each time and lifestyle intervention((1) Daily intake of 1200~1500kcal of energy, dietary carbohydrate function ratio of 45-55%, lipid energy supply ratio of 20-30%, protein energy ratio of 20-30% (2) At least 150 minutes of moderate-intensity physical activity (e.g., brisk walking) per week (3) Quit smoking and drinking, and adjust psychologically)
Other Names:
  • group 1(Pulse Acupuncture and Moxibustion Therapeutic Instrument:KWD-808I,KWD-808II,KWD-808III )
Active Comparator: metformin + intensive lifestyle intervention
8 weeks metformin treatment(metformin 500 mg three times a day with meals)+ intensive lifestyle intervention
Other: Metformin+lifestyle intervention
8 weeks Metformin 500 mg three times a day with meals and lifestyle intervention ((1) Daily intake of 1200~1500kcal of energy, dietary carbohydrate function ratio of 45-55%, lipid energy supply ratio of 20-30%, protein energy ratio of 20-30% (2) At least 150 minutes of moderate-intensity physical activity (e.g., brisk walking) per week (3) Quit smoking and drinking, and adjust psychologically)
Other Names:
  • group 2

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
the level of body fat distribution
Time Frame: up to 8 weeks
Compared with the baseline in two groups, the level of body fat distribution to evaluate weight control outcome
up to 8 weeks
Pregnancy rates after intervention
Time Frame: up to 1 year
Compared with the baseline in two groups, pregnancy rate is one of the index to evaluate reproductive outcome
up to 1 year
Body mass index
Time Frame: up to 8 weeks
Compared with the baseline in two groups, the level of body mass index to evaluate weight control outcome.
up to 8 weeks

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
Standardized TCM syndrome differentiation and classification of PCOS patients
Time Frame: up to 8 weeks
Through the "tongue and pulse image, meridians, and constitution identification collection analyzer" (registration certificate number: Ji Machinery Note 20202200354), the standardized TCM syndrome differentiation and classification of PCOS patients was clarified.
up to 8 weeks
Glucose metabolism
Time Frame: up to 8 weeks
the area under the curve (AUC insulin), fasting insulin, glucose, computational homeostatic model assessment (HOMA)-IR and HOMA-B (i.e., isis β cell function) were calculated during the insulin-to-glucose tolerance test (OGTT)
up to 8 weeks
Female menstrual pattern
Time Frame: up to 8 weeks
Sex hormones, anti-mullerian hormone (AMH) and 21-day progesterone measurement
up to 8 weeks
Intestinal bacteria microbiota
Time Frame: up to 8 weeks
Such measurement is tested through gene and microbiota testing. Those who have taken antibiotics and live bacteria within one week are excluded.
up to 8 weeks

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.
RenJi Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tao Tao, MD, RenJi Hospital Department of Endocrinology and Metabolism

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 (Estimated)

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.
December 20, 2024

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.
August 1, 2025

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.
June 1, 2026

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).
November 24, 2024

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 29, 2024

First Posted (Estimated)

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.
December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
December 4, 2024

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 29, 2024

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, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • IIT-2023-0156

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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