Polycystic Ovary SyndromeNCT06717087
Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight/Obese PCOS Patients
A study testing Acupuncture+lifestyle intervention and Metformin+lifestyle intervention in people with Polycystic Ovary Syndrome and Metformin, run by RenJi Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Metformin, Acupuncture
- What is being tested?
- Acupuncture+lifestyle intervention and Metformin+lifestyle intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Age from ≥ 20 years old (legal age of marriage) to ≤ 40 years old
- PCOS patients: BMI ≥ 25 to ≤40kg/m2.
- Willing to sign the consent form.
Who cannot join
- History of severe heart disease, hematologic disease;
- Known kidney disease (creatinine clearance rate <45mL/min), liver function ALT, AST more than 3 times the normal value, autoimmune disease or cancer;
- Any acute disease that has the potential to alter renal function or cause tissue hypoxia;
- Type I diabetes mellitus;
- 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);
- Allergy to metformin hydrochloride or any excipients;
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- Blood pressure > 160/100 mm Hg;
- Pregnancy or breastfeeding in the past three months;
- No history of acupuncture treatment within 2 months;
- Alcohol dependence
- Persons with disabilities with language impairment or reduced ability to understand the information provided;
- Those who have participated in other clinical studies within three months;
- The man clearly diagnoses infertility-related diseases and factors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200127
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome, Metformin, Acupuncture
- Being tested
- Acupuncture+lifestyle intervention, Metformin+lifestyle intervention
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture+lifestyle interventionOther
Also called group 1(Pulse Acupuncture and Moxibustion Therapeutic Instrument:KWD-808I,KWD-808II,KWD-808III )
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)
Metformin+lifestyle interventionOther
Also called group 2
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)
| Study group | Role | What they receive |
|---|---|---|
| acupuncture+ intensive lifestyle intervention | Experimental | 8 weeks acupuncture+ intensive lifestyle intervention Receives: Other: Acupuncture+lifestyle intervention |
| metformin + intensive lifestyle intervention | Active comparator | 8 weeks metformin treatment(metformin 500 mg three times a day with meals)+ intensive lifestyle intervention Receives: Other: Metformin+lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the level of body fat distribution
Compared with the baseline in two groups, the level of body fat distribution to evaluate weight control outcome
Measured: up to 8 weeks
Pregnancy rates after intervention
Compared with the baseline in two groups, pregnancy rate is one of the index to evaluate reproductive outcome
Measured: up to 1 year
Body mass index
Compared with the baseline in two groups, the level of body mass index to evaluate weight control outcome.
Measured: up to 8 weeks
Secondary outcomes (4)
Standardized TCM syndrome differentiation and classification of PCOS patients
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.
Measured: up to 8 weeks
Glucose metabolism
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)
Measured: up to 8 weeks
Female menstrual pattern
Sex hormones, anti-mullerian hormone (AMH) and 21-day progesterone measurement
Measured: up to 8 weeks
Intestinal bacteria microbiota
Such measurement is tested through gene and microbiota testing. Those who have taken antibiotics and live bacteria within one week are excluded.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Tao, MD, Principal investigator, RenJi Hospital Department of Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717087
- Sponsor's protocol ID
- IIT-2023-0156
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight/Obese Polycystic Ovary Syndrome Patients
- ClinicalTrials.gov ID
- NCT06717087
- Acronym / sponsor ID
- IIT-2023-0156
- Conditions
- Polycystic Ovary Syndrome, Metformin, Acupuncture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture+ intensive lifestyle intervention | Experimental | Other: Acupuncture+lifestyle intervention8 weeks acupuncture+ intensive lifestyle intervention |
| metformin + intensive lifestyle intervention | Active comparator | Other: Metformin+lifestyle intervention8 weeks metformin treatment(metformin 500 mg three times a day with meals)+ intensive lifestyle intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
- Age from ≥ 20 years old (legal age of marriage) to ≤ 40 years old
- PCOS patients: BMI ≥ 25 to ≤40kg/m2.
- Willing to sign the consent form.
Key exclusion criteria (13 listed)
- History of severe heart disease, hematologic disease;
- Known kidney disease (creatinine clearance rate <45mL/min), liver function ALT, AST more than 3 times the normal value, autoimmune disease or cancer;
- Any acute disease that has the potential to alter renal function or cause tissue hypoxia;
- Type I diabetes mellitus;
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture+lifestyle interventionAlso: group 1(Pulse Acupuncture and Moxibustion Therapeutic Instrument:KWD-808I,KWD-808II,KWD-808III )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 | acupuncture+ intensive lifestyle intervention |
| Metformin+lifestyle interventionAlso: group 28 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 | metformin + intensive lifestyle intervention |
Primary outcome
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
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
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.
4 secondary outcomes
Standardized TCM syndrome differentiation and classification of PCOS patients
Time frame: up to 8 weeks
Glucose metabolism
Time frame: up to 8 weeks
Female menstrual pattern
Time frame: up to 8 weeks
Intestinal bacteria microbiota
Time frame: up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tao Tao, MD principal investigator
RenJi Hospital Department of Endocrinology and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture+lifestyle intervention and Metformin+lifestyle intervention in people with Polycystic Ovary Syndrome and Metformin, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Tao, MD (+86-13817701776, taotaozhen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the level of body fat distribution (time frame: up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.