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A Randomized Controlled Trial of Lifestyle Intervention to Improve Endocrine and Metabolic Disorders in Adolescent PCOS

A Randomized Controlled Trial of Lifestyle Intervention to Improve Endocrine and Metabolic Disorders in Adolescent PCOS

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036436
Enrollment
Unknown
Registered
2020-08-23
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovarian syndrome

Interventions

Control:Periodic progesterone
Experimental group:Progesterone and Life style

Sponsors

International Peace Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
10 Years to 20 Years

Inclusion criteria

Inclusion criteria: 1. Chinese women aged 10 to 19 years; 2. According to the Rotterdam PCOS diagnostic criteria and the latest international guidelines for adolescent PCOS, the following three items were all met: (1) Irregular menstrual cycle defined according to the year after menarche; primary amenorrhea with any one cycle (more than 1 year after menarche) > 90 days, menstrual cycle 45 days (1-3 years after menarche), menstrual cycle 35 days (more than 3 years after menarche), and primary amenorrhea at the age of 15 years or more than 3 years after menarche. Irregular menstrual cycles (less than 1 year after menarche) represent normal puberty transition; (2) Hyperandrogenemia or clinical manifestations of hyperandrogenism (such as hirsutism, acne, etc.); (3) Ultrasound examination was performed 3-5 days after menstrual cycle or progesterone withdrawal. The results showed that there were more than 12 small follicles with diameter of 2-9 mm in both ovaries, that is, ovarian polycystic change, and / or ovarian volume increased (each side > 10 ml, ovarian volume = 0.15 x long cm x wide cm x thick cm); 3. Fully explain the nature of the study and obtain informed consent from the subject before performing any procedures specified in the study protocol. If the subject is incapable of expressing an opinion, written informed consent may be signed by the subject's legal representative.

Exclusion criteria

Exclusion criteria: Any of the following criteria should be excluded from this study: 1. Other causes of elevated androgen levels (including congenital adrenal hyperplasia, Cushing syndrome, androgen secreting tumors, etc.), and other diseases causing ovulation disorders (such as hyperprolactinemia, premature ovarian failure or hypothalamic pituitary amenorrhea, and thyroid dysfunction); 2. There are other serious metabolic diseases in endocrine system; 3. Severe cardiovascular disease, heart disease and intolerance of mild exercise.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose;Fasting insulin;OGTT 1/2h blood glucose;OGTT 1h blood glucose;OGTT 2h blood glucose;OGTT 3h blood glucose;Body fat ratio;BMI;Body adipose distribution;

Countries

China

Contacts

Public ContactXian-Hua Lin

International Peace Maternal and Child Health Hospital

xl_1290@126.com+86 18221939007

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026