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Polycystic Ovary SyndromeNCT06049186

CRD vs. Met in Patients With Obese PCOS Infertility

A study testing CRD and Metformin in people with Polycystic Ovary Syndrome, run by Shanghai First Maternity and Infant 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 The sponsor has not verified this record for over two years, so it may be out of date.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 common gynecological endocrine disease and a major cause of anovulatory infertility in reproductive-aged women. From 2010 to 2020, it was found that the prevalence of PCOS in reproductive-aged women in China reached 7.8%, an increase of 65% over 10 years ago. Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
CRD and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
1 siteChina
Study dates
15 Sep 2023to 31 Mar 2026
Phase
Interventional
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 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • a diagnosis of polycystic ovary syndrome (PCOS) based on the Rotterdam diagnostic criteria;
  • age 20-35 years old;
  • a body-mass index over 23;
  • have requirements for fertility.

Who cannot join

  • acute or chronic viral hepatitis;
  • serious liver dysfunction or chronic kidney disease;
  • serious cardiovascular or cerebrovascular disease;
  • patients with a history of acute/chronic infection, severe cardiovascular and cerebrovascular diseases, and malignant tumors;
  • have drugs for PCOS such as glucocorticoids and anti-androgen drugs (spironolactone, cyproterone acetate, flutamide, etc.) within 3 months;
  • congenital or secondary uterine abnormalities;
Show all 11Show fewer
  • use of medications that affect weight or energy balance such as Metformin within 3 months;
  • undergoing weight loss treatment (weight change greater than 5% in the past 3 months) or have a history of gastrointestinal surgery;
  • tubal obstruction;
  • the total number of motile sperm of male partner is less than 10 million;
  • any other situations that might affect the trial.

Trial locations and contacts

1 site in 1 country.

Miaoxin Chen, Dr contact

20261000

chenmiaoxin@51mch.com

China1 site, 1 recruiting
  • Shanghai First Maternity and Infant Hospital

    Shanghai, Shanghai Municipality, 201204

    Miao Chen, Dr, 20261000, chenmiaoxin@51mch.com

    Recruiting

Other trials in China

About this study

Official title: Comparison of Live Birth Rates Between Calorie-restricted Diets and Metformin Interventions Prior to Ovulation Induction Therapy in Patients With Overweight/Obese Polycystic Ovary Syndrome Combined With Infertility

Polycystic ovary syndrome (PCOS) is a common gynecological endocrine disease and a major cause of anovulatory infertility in reproductive-aged women. From 2010 to 2020, it was found that the prevalence of PCOS in reproductive-aged women in China reached 7.8%, an increase of 65% over 10 years ago. Many of them are overweight or obese. Weight loss including diet modifications can significantly reduce reproductive and metabolic disorders of PCOS and is recommended as a first step in the treatment of overweight or obese women with PCOS. Many weight loss programs have been proposed, including calorie-restriction diet (CRD) intervention. Whether CRD intervention prior to ovulation induction therapy could improve live birth rates in overweight/obese PCOS women has not been illustrated.

Read the detailed description

Polycystic ovary syndrome (PCOS) is a common gynecological endocrine disease and a major cause of anovulatory infertility in reproductive-aged women. Rotterdam criteria state the definition of PCOS is that women must present with two of the following three signs/symptoms-hyperandrogenism, chronic anovulation/oligomenorrhea, and polycystic ovaries-in the absence of other diseases that promote these symptoms. From 2010 to 2020, it was found that the prevalence of PCOS in reproductive-aged women in China reached 7.8%, an increase of 65% over 10 years ago. Many of them are overweight or obese. Weight loss including diet modifications can significantly reduce reproductive and metabolic disorders of PCOS and is recommended as a first step in the treatment of overweight or obese women with PCOS. Many weight loss programs have been proposed, including calorie-restriction diet (CRD) intervention. Whether CRD intervention prior to ovulation induction therapy could improve live birth rates in overweight/obese PCOS women has not been illustrated. This research is aimed to evaluate whether CRD intervention prior to ovulation induction could promote reproductive health in overweight or obese PCOS women with fertility requirements and provide an evidence-based nutrition advice for clinical practice.

Being tested
CRD, 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.

  • CRDBehavioural

    Also called Calorie-restricted diet

    During the initial 8 weeks of the trial, polycystic ovary syndrome (PCOS) patients are instructed to follow a diet of 1200 to 1500 kcal per day supervised by dietitians. The CRD includes a combination of 40 to 55% of calories from carbohydrates, 15 to 20% from protein, and 20 to 30% from fat; this regimen represented approximately 75% of the participants' daily caloric intake at baseline. All the participants receive dietary counseling daily during the trial.

  • MetforminDrug

    Also called Metformin treatment

    After randomization, patients entering the metformin group will be given 1500 mg daily (bid/tid) metformin and regular diets as control. Participants allocated to the control group are followed by the conventional approach (usual care) based on regular visits respecting the usual schedule dictated by the rules of general practice.

Study groups in NCT06049186
Study groupRoleWhat they receive
CRD groupExperimentalPatients in the calorie-restricted diet (CRD) group will have strict calorie-restriction diets for 8 weeks and then weight stability for 4 weeks.
Receives: Behavioral: CRD
Control groupActive comparatorPatients in the control group will receive regular diets and metformin 1500 mg daily for 12 weeks. Participants allocated to the control group are followed by the conventional approach (usual care) based on regular visits respecting the usual schedule dictated by the rules of general practice.
Receives: Drug: Metformin

What is being measured

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

  1. Live birth during the period of ovulation induction

    Live birth will be defined as the delivery of one or more living infants (≥22 week's gestation or birth weight more than 500g). The outcome could be assessed by clinical data and clinical diagnosis.

    Measured: 18 months

Secondary outcomes (24)
  1. Fasting blood glucose (FBG)

    A laboratory test that determines the level of glucose in the blood after an overnight fast, used especially to diagnose diabetes and prediabetes. The normal interval is 3.9-6.1mmol/L. The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  2. Fasting insulin (FINS)

    The level of insulin in the blood during fasting (usually in the morning when fasting). The normal interval is 5~20 μIU. The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  3. Oral glucose tolerance test (OGTT)

    An oral glucose tolerance test (OGTT) is a diagnostic tool used to evaluate how an individual's body metabolizes sugar. Often used to diagnose diabetic conditions, an oral glucose tolerance test requires minimal preparatory measures and may be safely administered during pregnancy. The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  4. Insulin release test (IRT)

    Quantitative oral glucose during fasting increases blood glucose and stimulates pancreatic β cells to release insulin. By measuring plasma insulin levels during fasting and 0.5h, 1h, 2h, and 3h after taking sugar, we can understand the secretion and reserve function of pancreatic β cells, which is also helpful for the classification of diabetes mellitus and guide treatment. The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  5. Blood lipid

    Lipid related indicators include cholesterol, triglycerides. The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  6. Kidney function index

    Blood tests that are included in the kidney function test include measuring for creatinine and blood urea nitrogen (BUN). The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  7. Liver function index

    Liver function index includes alanine aminotransferase (ALT), alkaline phosphatase (ALP) . The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  8. Free testosterone (FT)

    The average serum testosterone concentration is 0.43ng/ml, the high limit is 0.68ng/ml, if more than 0.7ng/m1 (equal to 2.44nmol/L), it is called hypertestosterone, or hyperandrogenemia. The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  9. Total testosterone (TT)

    The normal range of female testosterone is 0.1-0.75ng /ml, testosterone is the main sex hormone of the human body, men and women have secretion, male testosterone secretion is 20-30 times the amount of female testosterone secretion, it is very important to maintain the second sexual characteristics, bone and muscle strength. The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  10. Sex Hormone Binding Globulin (SHBG)

    A globulin synthesized by liver cells that can bind sex hormones, also known as testosterone - estrogen binding globulin or steroidal binding protein, is an important carrier of sex hormones, which can have an important impact on the regulation of sex hormone levels and bioavailability in the body. Clinical detection of SHBG level can provide scientific reference value for disease detection and judgment. The normal interval is 20-130nmol/L for women. The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  11. Liver transient elastography(TE)

    TE may be used to monitor disease progression or regression via serial measurements and to guide further management including treatment. The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  12. Weight

    Unit: kilogram (kg). The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  13. Height

    Unit: meter (m). The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  14. Body Mass Index (BMI)

    BMI = weight (in kg)/ height^2 (in m^2).

    Measured: Baseline period and 3 months

  15. Waist circumference

    Unit: centimeter (cm). The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  16. Body fat

    Body fat is measured by body fat scale. The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  17. Lean body weight

    Lean body weight refers to the total weight of organs, bones, and muscles. The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  18. Blood pressure (BP)

    Blood pressure is a measurement of the force of blood against the arterial walls when the heart pumps. The pressure is measured in millimeters of mercury (mmHg) and is expressed as two numbers. For example, the optimal BP for an adult is 120 over 80, or 120/80. A pressure reading of 120 over 80 or lower is considered healthy. If the systolic number ranges above 120 to 139 or the diastolic number ranges above 80 to 89, a person is considered to have pre-hypertension. Systolic readings from 140 to 159 or diastolic readings from 90 to 99 are classified as stage 1 hypertension. Systolic measurements of 160 or above or diastolic measurements of 100 or above indicate the severe condition of stage 2 hypertension. The outcome could be assessed by clinical data and clinical test.

    Measured: Baseline period and 3 months

  19. Hospital Anxiety and Depression Scale (HADS)

    The purpose of the HADS was to screen for clinically significant anxiety and depressive symptoms in medically ill patients. Content The HADS-A includes specific items that assess generalized anxiety including tension, worry, fear, panic, difficulties in relaxing, and restlessness. The total score for the HADS-A can range from 0 to 21. The following guidelines are recommended for the interpretation of scores: 0-7 for normal or no anxiety, 8-10 for mild anxiety, 11-14 for moderate anxiety, and 12-21 for severe anxiety.

    Measured: Baseline period and 3 months

  20. Biochemical pregnancy

    A pregnancy diagnosed only by the detection of beta hCG in serum or urine. The outcome could be assessed by clinical data and clinical diagnosis.

    Measured: 8 months

  21. Ectopic pregnancy

    Ectopic pregnancy (EP) is defined as the implantation and development of a fertilized ovum anywhere outside of the uterine cavity. The outcome could be assessed by clinical data and clinical diagnosis.

    Measured: 8 months

  22. Pregnancy failure

    Pregnancy failure, otherwise termed as pregnancy loss or miscarriage, can occur at different stages during this process and many different pathophysiological mechanisms may be implicated. The outcome could be assessed by clinical data and clinical diagnosis.

    Measured: 8 months

  23. Birth weight

    Macrosomia is defined in a newborn as a birth weight more than two standard deviations above the mean percentile for gestational age, >90th percentile weight for gestational age, or a birth weight greater than 4000g at term. The outcome could be assessed by clinical data and clinical diagnosis.

    Measured: 18 months

  24. Neonatal complications

    Neonatal complications include intraventricular hemorrhage, necrotizing enterocolitis, respiratory distress syndrome, bronchopulmonary dysplasia, jaundice. The outcome could be assessed by clinical data and clinical diagnosis.

    Measured: 18 months

Timeline

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

  1. First posted22 Sep 2023
  2. Study start15 Sep 2023 (estimated)
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

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
Model description
Comparison of live birth rates between calorie-restricted diets and metformin interventions prior to ovulation induction therapy in patients with overweight/obese polycystic ovary syndrome combined with Infertility.
Masking
None (open label)
Enrolment
406 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06049186
Sponsor's protocol ID
CRD vs. Met in PCOS
Status last verified
Sep 2023
First submitted
31 Aug 2023
Last updated
22 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yang R, Li Q, Zhou Z, Qian W, Zhang J, Wu Z, Jin L, Wu X, Zhang C, Zheng B, Tan J, Hao G, Li S, Tian T, Hao Y, Zheng D, Wang Y, Norman RJ, Li R, Liu P, Qiao J. Changes in the prevalence of polycystic ovary syndrome in China over the past decade. Lancet Reg Health West Pac. 2022 May 31;25:100494. doi: 10.1016/j.lanwpc.2022.100494. eCollection 2022 Aug.

    PubMed 35669932
  • Lie Fong S, Douma A, Verhaeghe J. Implementing the international evidence-based guideline of assessment and management of polycystic ovary syndrome (PCOS): how to achieve weight loss in overweight and obese women with PCOS? J Gynecol Obstet Hum Reprod. 2021 Jun;50(6):101894. doi: 10.1016/j.jogoh.2020.101894. Epub 2020 Aug 16.

    PubMed 32814159
  • Shahid R, Iahtisham-Ul-Haq, Mahnoor, Awan KA, Iqbal MJ, Munir H, Saeed I. Diet and lifestyle modifications for effective management of polycystic ovarian syndrome (PCOS). J Food Biochem. 2022 Jul;46(7):e14117. doi: 10.1111/jfbc.14117. Epub 2022 Feb 24.

    PubMed 35199348
  • Szczuko M, Kikut J, Szczuko U, Szydlowska I, Nawrocka-Rutkowska J, Zietek M, Verbanac D, Saso L. Nutrition Strategy and Life Style in Polycystic Ovary Syndrome-Narrative Review. Nutrients. 2021 Jul 18;13(7):2452. doi: 10.3390/nu13072452.

    PubMed 34371961
  • Paoli A, Mancin L, Giacona MC, Bianco A, Caprio M. Effects of a ketogenic diet in overweight women with polycystic ovary syndrome. J Transl Med. 2020 Feb 27;18(1):104. doi: 10.1186/s12967-020-02277-0.

    PubMed 32103756
  • Lu Y, Qu J, Yang Y, Sun J, Geng L, Hong L, Moran L, Teede H, Zhang M, Wang L, Chen M. Comparison of live birth rates between calorie-restricted diet and metformin prior to ovulation induction therapy in women with polycystic ovary syndrome and overweight/obesity: a protocol for a multicenter, randomized comparative effectiveness trial. Front Public Health. 2026 Sep 10;14:1881719. doi: 10.3389/fpubh.2026.1881719. eCollection 2026.

    PubMed 42787272

Questions about this trial

What is this clinical trial studying?

A study testing CRD and Metformin in people with Polycystic Ovary Syndrome, run by Shanghai First Maternity and Infant 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 11 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 22 Sep 2023. 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 Miaoxin Chen, Dr (20261000, chenmiaoxin@51mch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live birth during the period of ovulation induction (time frame: 18 months). 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 NCT06049186, which also lists 6 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 22 Sep 2023.

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