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Not yet recruitingNCT06717087Updated Dec 4, 2024

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

An interventional study of Acupuncture+lifestyle intervention and Metformin+lifestyle intervention in Polycystic Ovary Syndrome, Metformin and Acupuncture, sponsored by RenJi Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Polycystic Ovary Syndrome
  • Metformin
  • Acupuncture
03

In context

Polycystic Ovary Syndrome

975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.

This study's planned enrollment of 92 is above the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 550 studies on the registry; 248 are open to participants now.

Browse RenJi Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
92 participants (estimated)

Study arms

  • Experimental
    acupuncture+ intensive lifestyle intervention

    8 weeks acupuncture+ intensive lifestyle intervention

    Other: Acupuncture+lifestyle intervention

  • 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

Interventions

  • OtherAcupuncture+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)

    Also known as: group 1(Pulse Acupuncture and Moxibustion Therapeutic Instrument:KWD-808I,KWD-808II,KWD-808III )

  • OtherMetformin+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)

    Also known as: group 2

06

What researchers measure

Primary outcomes

  1. the level of body fat distribution

    Compared with the baseline in two groups, the level of body fat distribution to evaluate weight control outcome

    Time frame: up to 8 weeks

  2. Pregnancy rates after intervention

    Compared with the baseline in two groups, pregnancy rate is one of the index to evaluate reproductive outcome

    Time frame: up to 1 year

  3. Body mass index

    Compared with the baseline in two groups, the level of body mass index to evaluate weight control outcome.

    Time frame: up to 8 weeks

Secondary outcomes

  1. 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.

    Time frame: up to 8 weeks

  2. 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)

    Time frame: up to 8 weeks

  3. Female menstrual pattern

    Sex hormones, anti-mullerian hormone (AMH) and 21-day progesterone measurement

    Time frame: up to 8 weeks

  4. 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.

    Time frame: up to 8 weeks

07

Study locations

1 site
  • Renji Hospital, School of Medicine, Shanghai Jiaotong University
    Shanghai, 200127, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2024; primary completion for Aug 2025, 7 months later.

Of 206 non-industry interventional studies with no phase under Polycystic Ovary Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's planned 7 months is below that.

Counting every sponsor, half of 221 studies reached it within 18 months; a quarter within 7 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 24, 2024
First posted
Dec 4, 2024
StartEst.
Dec 20, 2024
Primary completionEst.
Aug 1, 2025
CompletionEst.
Jun 1, 2026
Last update
Dec 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06717087
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Dec 4, 2024
Start date
Dec 20, 2024 (estimated)
Primary completion
Aug 1, 2025 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Dec 4, 2024

Study contacts

Tao Tao, MD
Contact
taotaozhen@hotmail.com
+86-13817701776
Tao Tao, MD
principal investigator · RenJi Hospital Department of Endocrinology and Metabolism

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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