Skip to content

The combination of "disease and syndrome" treatment on ovulatory dysfunction infertility: A randomized controlled trail

The combination of disease and syndrome treatment onovulatory dysfunction infertility: A randomized controlled trail

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-14005404
Enrollment
Unknown
Registered
2014-10-27
Start date
2012-12-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

infertility

Interventions

Chinese herbal medicine group:Chinese herbal medicine
Conventional medicine:Conventional medicine

Sponsors

Guangdong Provincal hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Infertility is the failure to conceive (regardless of cause) after 1 year of unprotected intercourse; 2. Meet the western medicine diagnostic criterion and syndrome criterion in TCM; (1) Infertility diagnostic criterion: Infertility is the failure to conceive (regardless of cause) after 1 year of unprotected intercourse, the sexual function of the sexual partner is normal; (2) Anovulation diagnostic criterion: i. Single phase basal body temperature for 3months; ii. No cyclical changes with Vaginal exfoliated cells; iii. No cyclical changes with cervical mucus crystalization, without ellipsoid; iv. Without typical secretory phase change in endometria examination; v. No ovulation with B ultrasound monitoring; vi. Progesterone is lower than 3.2ng/ml in the luteal phase. If 3 criterion of 6 were meet, anovulatory can be diagnosted. (2) Oligoovulation diagnostic criterion; The period of menstruation is longer than 35days or no ovulation time longer than 3 months in 1 years. (3) Polycystic ovary syndrome diagnostic criterion: using 2003 a consensus workshop sponsored by ESHRE/ASRM in Rotterdam: i. oligoovulation and/or anovulation; ii. excess androgen activity; iii. polycystic ovaries (by gynecologic ultrasound). PCOS can be diagnosed if the patient is presentany 2 out of 3 criteria. Other entities which cause hyperandrogenism are excluded that would cause these, such as hyperprolactinemia, thyroid disease, Cushing syndrome and so on. The syndrome diagnostic criterion of Traditional Chinese medicine. i. patient without PCOS; Kidney "Yang" deficiency: Main symptoms: infertility; delayed menstrual period or amenorrhea. Other symptoms: Less Leucorrhea, sexual apathy, weakness in the loins and knees, dizziness, Lassitude, not warm in the extremity, loose stool, frequency urination or nocturnal urination. Paled tongue, thine and deep pulse; ii. PCOS with hyperandrogenism and slim figue; Deficiency in liver and kidney syndrome; Main symptoms: infertility; delayed menstrual period or amenorrhea; Other symptoms: Slime, fever in palm and sole, throat, face acne or Too much hair grease, dry stool, deep color of urination, red tongue, thin coat, thin and rapid pulse. iii. PCOS with insulin insistence and fat figure; Deficiency in kidney with palm and phlegmatic hygrosis syndrome; Main symptoms: infertility; delayed menstrual period or amenorrhea; Other symptoms: fat figue, dizziness, hypodynamia, nausea, phlegm in the throat, dry or loose stool. Pink tongue with thin white coat or white greasy, deep and slippery or thine and slippery pulse; 3. Women aged 20-35 years; 4. Stable vital signs, no consciousness disorder.

Exclusion criteria

Exclusion criteria: 1. Infertility caused by immune disorder factor, tubal factor or sexual partner factor or unknown cause; 2. Reproductive malformation or Congenital hypoplasia, or endometrial damage caused by uterine cavity; operation, pituitary tumor, ovary tumor ect, which can cause infertility; 3. Big uterine fibroid or serious adenomyosis, endometriosis which can affect contraception; 4. adrenal glands or thyroid gland dysfunction which can cause ovulatory dysfunction; 5. Ovulatory dysfunction caused by tumor, chromosome abnormalities or other disease; 6. Ovulatory dysfunction in lactation period; 7. Ovulatory dysfunction caused by high follicle stimulating hormone or low follicle stimulating hormone or hyperprolactinemia; 8. Patients who has receive ovulation treatment by western medicine in recent three years; 9. Serious internal medical conditionseg, hepatic, heart or renal dysfunction or thyroid disease or mood disorder diease; 10 Don not receive informed consent.

Design outcomes

Primary

MeasureTime frame
ovulation rate;fertility rate;Live birth rate;

Countries

Chine

Contacts

Public ContactXiaoyun Wang
jiaoshouw@163.com+86 18922108066

Outcome results

None listed

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