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Polycystic Ovary SyndromeNCT05463627

Effects of Metformin on Metabolic and Reproductive Outcomes in Chinese PCOS Patients

An observational study of Polycystic Ovary Syndrome and Metformin, run by RenJi Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Polycystic ovary syndrome (PCOS) is a reproductive endocrine disease characterized by reproductive and metabolic abnormalities, which is a crucial cause of female infertility and an essential risk factor for type 2 diabetes. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome, Metformin
What is being tested?
Metformin
How many people
1,440 participants
Where
1 siteChina
Study dates
1 Jan 2016to 1 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Obese,overweight and normal-weight women aged 18-45 years (in childbearing age)with PCOS or/and IGR/DM were expected enrolled in our study

Who may be able to join

  • Females at the age of 18-45years old;
  • Diagnosed with PCOS or/and impaired glucose regulation (IGR)/diabetes(DM)
  • Metformin regimens were used without other metabolic agents
  • The diagnosis of PCOS is based on the 2003 Rotterdam criteria and the diagnostic criteria for impaired glucose regulation (IGR) and type 2 diabetes are based on the 2021 American Diabetes Association(ADA) diagnosis criteria.

Who cannot join

  • Severe liver and kidney dysfunction (ALT is greater than 2.5 times the upper limit of normal, or Cr>132umol/l, or eGFR <60 mL/min/1.73m2), psychosis, accompanied by severe infection, severe anemia, neutropenia disease;
  • Participated in clinical trials of other drugs within 3 months;
  • In the past 5 years, there have been treated or untreated organ system tumors (except local skin basal cell carcinoma), regardless of whether there is evidence of local recurrence or metastasis;
  • A history of psychoactive substance abuse, including alcohol and a history of alcohol-related illnesses in the past 2 years;
  • Any conditions judged by the investigator that affect enrollment.

Trial locations and contacts

1 site in 1 country.

Tao Tao, Dr. contact

86-021-68383073

taotaosh76@163.com

China1 site, 1 recruiting

  • Renji Hospital Department of Endocrinology and Metabolism

    Shanghai, Shanghai Municipality

    Wei Liu, MD, +86-18918358342, sue_liuwei@163.com

    Tao Tao, MD, +86-021-68383073, taotaosh76@163.com

    Recruiting

Other trials in China

About this study

Polycystic ovary syndrome (PCOS) is a reproductive endocrine disease characterized by reproductive and metabolic abnormalities, which is a crucial cause of female infertility and an essential risk factor for type 2 diabetes. At present, there exist several clinical trials and studies on the usage of metformin in the treatment of PCOS patients in prediabetes, and the practical application of metformin in clinical practice has years of history. The treatment plan of metformin is of great significance in preventing type 2 diabetes in PCOS patients and assisting pregnancy in PCOS infertile patients.

Read the detailed description

The purpose of this study is to conduct a real world study on effects of metformin on the improvement of metabolism and reproductive outcome in Chinese prediabetic PCOS patients by collecting relevant medical system records from Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine as real world data and a significant supplement to clinical trial studies. At the same time, obese and non-obese PCOS patients may have different mechanisms of insulin resistance, so this study stratified PCOS patients to analyze whether metformin can improve treatment results for PCOS patients with prediabetes according to different body mass index (BMI).The investigator's study is the first real world study to investigate Chinese pre-diabetes PCOS patients treated by metformin and the metabolic and reproductive outcomes, which is innovative. The investigator's research also has a guiding significance for the practical application of metformin in improving glucose metabolism and reproductive outcomes in patients with different body weight in clinical practice, and has great relevance for PCOS patients to reduce long-term complications and improve quality of life.

Being tested
Metformin
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.

  • MetforminDrug

    Also called melbine

    All participants among the three groups were treated with metformin

Study groups in NCT05463627
Study groupRoleWhat they receive
BMI<24 kg/m2women diagnosed with PCOS with BMI<24 kg/m2
Receives: Drug: Metformin
BMI24-28 kg/m2women diagnosed with PCOS with BMI24-28 kg/m2
Receives: Drug: Metformin
BMI>28 kg/m2women diagnosed with PCOS with BMI>28kg/m2
Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reversed insulin resistance or restored glucose homeostasis in women with PCOS

    Compared with the baseline in three groups, the rate of reversed insulin resistance or restored glucose homeostasis

    Measured: 5 years

Secondary outcomes (20)

  1. change in the level of BMI

    Compared with the baseline in three groups, the level of BMI is one of the metabolic index to evaluate metabolic outcome

    Measured: 5 years

  2. change in the level of glycated hemoglobin(HbA1c)

    Compared with the baseline in three groups, the level of HbA1c is one of the metabolic index to evaluate glucose metabolic outcome

    Measured: 5 years

  3. change in the level of 0'-180'Plasma Glucose(PG)

    Compared with the baseline in three groups, the level of 0'-180'PG from oral glucose tolerance test is one of the metabolic index to evaluate glucose metabolic outcome

    Measured: 5 years

  4. change in the level of 0'-180'insulin(ins)

    Compared with the baseline in three groups, the level of 0'-180'ins from oral glucose tolerance test is one of the metabolic index to evaluate glucose metabolic outcome

    Measured: 5 years

  5. change in the level of 0'-180'C-Peptide

    Compared with the baseline in three groups, the level of 0'-180'C-Peptide from oral glucose tolerance test is one of the metabolic index to evaluate glucose metabolic outcome

    Measured: 5 years

  6. change in the level of β cell homeostatic model assessment(HOMA-β)

    Compared with the baseline in three groups, the level of HOMA-β calculated from oral glucose tolerance test is one of the metabolic index to evaluate glucose metabolic outcome

    Measured: 5 years

  7. change in the level of Matsuda Index(MI)

    Compared with the baseline in three groups, the level of MI calculated from oral glucose tolerance test is one of the metabolic index to evaluate glucose metabolic outcome

    Measured: 5 years

  8. change in the level of deposition index(DI)

    Compared with the baseline in three groups, the level of DI calculated from oral glucose tolerance test is one of the metabolic index to evaluate glucose metabolic outcome

    Measured: 5 years

  9. change in the level of waist-hip ratio(WHR)

    Compared with the baseline in three groups, the level of WHR is one of the metabolic index to evaluate metabolic outcome

    Measured: 5 years

  10. change in the level of Luteinizing hormone(LH)

    Compared with the baseline in three groups, the level of LH is one of the metabolic index to evaluate Reproductive outcome

    Measured: 5 years

  11. change in the level of Follicle stimulating hormone(FSH)

    Compared with the baseline in three groups, the level of FSH is one of the metabolic index to evaluate Reproductive outcome

    Measured: 5 years

  12. change in the level of Prolactin(PRL)

    Compared with the baseline in three groups, the level of PRL is one of the metabolic index to evaluate Reproductive outcome

    Measured: 5 years

  13. change in the level of estradiol(E2)

    Compared with the baseline in three groups, the level of E2 is one of the metabolic index to evaluate Reproductive outcome

    Measured: 5 years

  14. change in the level of testosterone(T)

    Compared with the baseline in three groups, the level of T is one of the metabolic index to evaluate Reproductive outcome

    Measured: 5 years

  15. change in the level of Sex hormone-binding globulin(SHBG)

    Compared with the baseline in three groups, the level of SHBG is one of the metabolic index to evaluate Reproductive outcome

    Measured: 5 years

  16. change in the level of Dehydroepiandrosterone sulfate(DHEAS)

    Compared with the baseline in three groups, the level of DHEAS is one of the metabolic index to evaluate Reproductive outcome

    Measured: 5 years

  17. change in the level of Androstenedione(A2)

    Compared with the baseline in three groups, the level of A2 is one of the metabolic index to evaluate Reproductive outcome

    Measured: 5 years

  18. pregnancy rate

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

    Measured: 5 years

  19. live birth rate

    Compared with the baseline in three groups, live birth rate is one of the index to evaluate Reproductive outcome

    Measured: 5 years

  20. improvement rate of menstrual cycle

    Compared with the baseline in three groups, improvement rate of menstrual cycle is one of the index to evaluate Reproductive outcome

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2022
  2. Study start1 Jan 2016
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion1 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05463627
Sponsor's protocol ID
KY2021-184-B
Status last verified
Mar 2022
First submitted
24 Mar 2022
Last updated
19 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pedersen AJT, Stage TB, Glintborg D, Andersen M, Christensen MMH. The Pharmacogenetics of Metformin in Women with Polycystic Ovary Syndrome: A Randomized Trial. Basic Clin Pharmacol Toxicol. 2018 Feb;122(2):239-244. doi: 10.1111/bcpt.12874. Epub 2017 Sep 19.

    PubMed 28834135

  • Li Y, Tan J, Wang Q, Duan C, Hu Y, Huang W. Comparing the individual effects of metformin and rosiglitazone and their combination in obese women with polycystic ovary syndrome: a randomized controlled trial. Fertil Steril. 2020 Jan;113(1):197-204. doi: 10.1016/j.fertnstert.2019.09.011. Epub 2019 Nov 9.

    PubMed 31718828

  • Xiong F, Xiao J, Bai Y, Zhang Y, Li Q, Lishuang X. Metformin inhibits estradiol and progesterone-induced decidualization of endometrial stromal cells by regulating expression of progesterone receptor, cytokines and matrix metalloproteinases. Biomed Pharmacother. 2019 Jan;109:1578-1585. doi: 10.1016/j.biopha.2018.10.128. Epub 2018 Nov 15.

    PubMed 30551411

Questions about this trial

What is this clinical trial studying?

An observational study of 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 5 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: status not confirmed, as of the sponsor's last update on 19 Jul 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tao Tao, Dr. (86-021-68383073, taotaosh76@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reversed insulin resistance or restored glucose homeostasis in women with PCOS (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05463627, which also lists 3 linked publications.

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 19 Jul 2022.

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