Clinical trial NCT06049186: CRD vs. Met in Patients With Obese PCOS Infertility
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Shanghai 10th People's Hospital
First posted: 2023-09-22
Enrollment: 406
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Live birth during the period of ovulation induction
timeFrame: 18 months
Secondary outcomes:
measure: Fasting blood glucose (FBG)
timeFrame: Baseline period and 3 months
measure: Fasting insulin (FINS)
timeFrame: Baseline period and 3 months
measure: Oral glucose tolerance test (OGTT)
timeFrame: Baseline period and 3 months
measure: Insulin release test (IRT)
timeFrame: Baseline period and 3 months
measure: Blood lipid
timeFrame: Baseline period and 3 months
measure: Kidney function index
timeFrame: Baseline period and 3 months
measure: Liver function index
timeFrame: Baseline period and 3 months
measure: Free testosterone (FT)
timeFrame: Baseline period and 3 months
measure: Total testosterone (TT)
timeFrame: Baseline period and 3 months
measure: Sex Hormone Binding Globulin (SHBG)
timeFrame: Baseline period and 3 months
measure: Liver transient elastography(TE)
timeFrame: Baseline period and 3 months
measure: Weight
timeFrame: Baseline period and 3 months
measure: Height
timeFrame: Baseline period and 3 months
measure: Body Mass Index (BMI)
timeFrame: Baseline period and 3 months
measure: Waist circumference
timeFrame: Baseline period and 3 months
measure: Body fat
timeFrame: Baseline period and 3 months
measure: Lean body weight
timeFrame: Baseline period and 3 months
measure: Blood pressure (BP)
timeFrame: Baseline period and 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline period and 3 months
measure: Biochemical pregnancy
timeFrame: 8 months
measure: Ectopic pregnancy
timeFrame: 8 months
measure: Pregnancy failure
timeFrame: 8 months
measure: Birth weight
timeFrame: 18 months
measure: Neonatal complications
timeFrame: 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
state: Shanghai
Study officials:
affiliation: Shanghai First Maternity and Infant Hospital
name: Miaoxin Chen, Dr
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.