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Clinical randomized controlled trial of Qigong pill combined with IVF-ET in the treatment of phlegm-damp polycystic ovary syndrome infertility

Effect of Qigong Pill on the expression of apoptosis-related protein gene of ovarian granulosa cells in infertile patients with phlegm-damp polycystic ovary syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063299
Enrollment
Unknown
Registered
2022-09-03
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Polycystic Ovary Syndrome

Interventions

Qigong Pill Treatment Group:Oral OC + Qigong pill decoction, twice a day, until the trigger day.
placebo control group:Oral OC + placebo, twice a day, until the trigger day.

Sponsors

Dalian Women and Children's Medical Group
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Aged 25-40 years; 2. Meet the diagnostic criteria of PCOS: oligomenorrhea or amenorrhea or irregular uterine bleeding is a necessary condition for diagnosis, in addition to one of the following two items, namely suspected PCOS can be diagnosed: (1) Clinical manifestations of hyperandrogenism or hyperandrogenism; (2) Ultrasound manifestations are >= 12 follicles with a diameter of 2-9 mm in one or both ovaries, or ovarian volume >= 10cm3; With the above-mentioned suspected PCOS diagnostic conditions, other diseases that may cause hyperandrogenism and diseases that cause abnormal ovulation must be excluded one by one to confirm the diagnosis; 3. Meet the diagnostic criteria of infertility certificate: couples of childbearing age who have normal sexual life and live together for 1 year or more without pregnancy without contraception; 4. Meet the diagnostic criteria for phlegm-dampness syndrome: amenorrhea, infertility; concurrent symptoms: physical fatigue, drowsiness, lethargy, fatigue, or low menstrual flow, dull menstrual color, or fullness in the chest and abdomen, or excessive vaginal discharge, pale tongue or tooth marks and white coating or white greasy, slippery pulse or heavy, slow, ups and downs. The main certificate has 1 item, and the secondary certificate has 3 or more items; 5. Voluntarily participate in this trial and sign the informed consent; 6. Those who intend to undergo IVF-ET assisted pregnancy in our center.

Exclusion criteria

Exclusion criteria: 1. Severe endometriosis, such as adenomyosis, ovarian chocolate cyst; 2. Uncured endometrial diseases, such as endometrial polyps, endometrial lesions, intrauterine adhesions, etc.; 3. Congenital uterine malformation or lack of ovaries; 4. Bilateral hydrosalpinx; 5. Complicated with diabetes, hypertension, thyroid disease, etc.; 6. Those who participated in other clinical trials at the same time during treatment or were unable to follow up and take medicine on time; 7. Those who planned to undergo IVF whole embryo freezing.

Design outcomes

Primary

MeasureTime frame
clinical pregnancy rate;

Secondary

MeasureTime frame
Total amount of Gn;Days using Gn;Endometrial thickness on HCG day;Number of eggs retrieved;High quality embryo rate;Incidence of Ovarian hyperstimulation syndrome;Scores of each dimension of Chinese quality of life scale;

Countries

China

Contacts

Public ContactMeiwei Zhang

Dalian Women and Children's Medical Group

404443615@qq.com+86 18845723085

Outcome results

None listed

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