Skip to content

Health technology assessment study of traditional Chinese medicine for premature ovarian insufficiency in pregnancy outcome based on real world data

Basic scientific research Funds of China Academy of Chinese Medical Sciences

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055886
Enrollment
Unknown
Registered
2022-01-22
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

premature ovarian insufficiency

Interventions

Traditional Chinese medicine treatment group:None
The conventional treatment control group:None

Sponsors

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnosis of early onset ovarian insufficiency (POI) based on the 2016 European Society of Human Reproduction and Embryology (ESHRE) POI guidelines: (1) Aged under 40 years old; (2) Two measurements (the second to fourth day of the menstrual cycle test, at least 4 weeks apart) FSH>25 iu/L; (3) Menstrual thinning or amenorrhea for at least 4 months. 2. Married women older than 18 years old have the requirement to have children; 3. Voluntarily participate in the study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Congenital abnormal development of reproductive organs, or hysterectomy, bilateral ovaries or bilateral salpingectomy; 2. Polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, hypothyroidism, chronic adrenal hypothyroidism and other endocrine diseases affecting ovulation; 3. Complicated with serious cardiovascular, cerebrovascular, liver, kidney, hematopoietic system or malignant tumor, mental disease; 4. No pregnancy outcome; 5. POI subclinical patients; 6. The male body is healthy (no organic lesions in the reproductive system), and semen routine is basically normal; 7. Those who meet the inclusion criteria but cannot objectively cooperate with treatment;

Design outcomes

Primary

MeasureTime frame
Pregnancy outcomes;

Secondary

MeasureTime frame
AMH;Follicle stimulating hormone;Luteinizing hormone;Estradiol;Progesterone;Testosterone;Prolactin;MENQoL scale;FertiQoL scale;Adverse event;Health economics;

Countries

China

Contacts

Public ContactLiu Jia

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine Sciences

marie_liujia@sina.cn+86 18810877011

Outcome results

None listed

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