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Efficacy and safety of traditional Chinese medicine (Ding-Kun-Dan) for infertility women with poor ovarian response (POR): multicenter, randomized controlled clinical trial

Efficacy and safety of traditional Chinese medicine (Ding-Kun-Dan) for infertility women with poor ovarian response (POR): multicenter, randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17011697
Enrollment
Unknown
Registered
2017-06-19
Start date
2017-06-14
Completion date
Unknown
Last updated
2018-02-19

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

Conditions

poor ovarian response

Interventions

treatment group:Oral Dingkun Dan for three months
control group:No intervention

Sponsors

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. The patients aged 25 to 38 years old; 2. Regular menstrual cycle (25-35 days); 3. Patients who consistent with poor ovarian respond diagnosis ; 4. Patients who met the infertility criteria (if the age<35 years old, subfertility=1 year; If the age =35 years old, subfertility=6months. The infertility duration will not betaken into account if there is any causes to disorder the transport of the gamete, such as oviduct obstruction, after tubal sterilization, etc.); 5. Patients who prepare to receive IVF/ICSI; 6. Willing to accept the test and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. With other endocrine diseases and autoimmune diseases, such as polycystic ovary syndrome, hyperlipidemia, Kaohsiung hormone, thyroid dysfunction, diabetes; 2. With other reproductive system diseases such as endometriosis, endometrial tuberculosis, intrauterine adhesions, uterine fibroids (submucous uterine myoma or not submucousmyoma but the diameter>4cm or oppress to endometrium), uterine malformation (uterus duplex, bicornuate uterus, unicornous uterus, septet uterus, etc.) hydrosalpinx; 3. With severe primary disease of internal medicine, surgery and psychiatric; 4. The female or her husband merged with genetic or acquired diseases; 5. Intake hormone drugs or Chinese herb (such as contraceptive drugs, ovulation-stimulating medicine, glucocorticoid etc) in 3 months prior to study entry; 6. Allergic to any ingredient within research drugs.

Design outcomes

Primary

MeasureTime frame
ongoing pregnancy rate;

Secondary

MeasureTime frame
the change of serum AMH level;total gonadotropins dosage;duration of stimulation;cycle cancellation rate;the number of retrieved oocytes;high qualified embryo rate;biochemical pregnancy rate;the change of serum FSH level;the change of AFC;the change of serum E2 level;serum estradiol and progesterone level on the day of hCG administration;

Countries

China

Contacts

Public ContactTian Xia

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

xiatian76@163.com+86 15822238896

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 7, 2026