CRD vs. Met in Patients With Obese PCOS Infertility

NCT06049186 | Recruiting

• 1 other identifier: CRD vs. Met in PCOS
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (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.

  18 months

Secondary Outcomes (24)

• Fasting blood glucose (FBG)

  Baseline period and 3 months

• Fasting insulin (FINS)

  Baseline period and 3 months

• Oral glucose tolerance test (OGTT)

  Baseline period and 3 months

• Insulin release test (IRT)

  Baseline period and 3 months

• Blood lipid

  Baseline period and 3 months

Study Arms (2)

CRD group

EXPERIMENTAL

Patients in the calorie-restricted diet (CRD) group will have strict calorie-restriction diets for 8 weeks and then weight stability for 4 weeks.

Behavioral: CRD

Control group

ACTIVE COMPARATOR

Patients 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.

Drug: Metformin

Interventions

CRD BEHAVIORAL

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.

Also known as: Calorie-restricted diet

CRD group

Metformin DRUG

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.

Also known as: Metformin treatment

Control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead
• RenJi Hospital: collaborator
• Shanghai 10th People's Hospital: collaborator

Study Sites (1)

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 201204, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 35669932 BACKGROUND

• 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.

  PMID: 32814159 BACKGROUND

• 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.

  PMID: 35199348 BACKGROUND

• 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.

  PMID: 34371961 BACKGROUND

• 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.

  PMID: 32103756 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Caloric Restriction; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Miaoxin Chen, Dr

  Shanghai First Maternity and Infant Hospital

  STUDY CHAIR

Central Study Contacts

Miaoxin Chen, Dr

CONTACT

20261000; chenmiaoxin@51mch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 22, 2023
• Study Start: September 15, 2023
• Primary Completion: January 1, 2026
• Study Completion: March 31, 2026
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)