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A Randomized, Open, Phase IV Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Acupunture on the outcome of Induction of Ovulation in woman with Poor Ovarian Response

A Randomized, Open, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Acupunture on the outcome of Induction of Ovulation in woman with Poor Ovarian Response

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0002623
Enrollment
70
Registered
2017-12-29
Start date
2017-07-17
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Medical Device : 1. Medical devices for clinical use: Disposable stainless steel sterilized needle (diameter 0.25mm, length 3cm, Dongbangmedical, Korea) 2. Procedure period and times: 8 weeks at 2 day
Acupuncture + In vitro fertilization procedure&#39
, Total 16 times. 3. Procedure - acupuncture point (total 14, no individual differences) A: one side: CV4, CV3 B: Both sides: EX-CA1, SP6, KI3, SP10, ST36, LR3 - infiltration depth: 10 to 20 mm -

Sponsors

Korea Institute of Oriental Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Who have voluntarily signed a written consent to participate in the trial 2) Women whose infertility period is more than one year or who have been diagnosed with infertility in medical institutions. 3) Who have been diagnosed with a poor ovarian response (POR) within the past 3 months (included in at least two of the following criteria). ? Advaned maternal age (=40 years) or any other risk factor for POR ? A previous POR (=3 oocytes with a conventional stimulation protocol) ? An abnormal ovarian reserve test (Anti-mullerian hormone (AMH)<0.5-1.1 ng/ml or total antral follicle count <5-7 follicles) 4) Persons between the ages of 20 and 45 under the written consent day 5) Who have the ability and willingness to take the test during the clinical trial period.

Exclusion criteria

Exclusion criteria: 1) Who can not receive acupuncture treatment for 2 months 2) Who are taking or administer medicines and procedures related to pregnancy, such as hormone, herbal medicine, and moxibustion treatment 3) Whose menstrual cycle is less than 21 days, more than 40 days, irregular 4) Azoospermia male 5) Polycystic ovary syndrome, thyroid disease, hyperprolactinemia, etc. ovulation disorder 6) Persons with physical or mental impairment who may be exposed to risk by participating in this clinical trial under test, who may cause confusion in results, or fail to comply with the requirements of the clinical trial 7) Who have a neurological or psychologically pathologic history or are currently suffering from a disease 8) Who can not be treated by acupuncture due to skin diseases such as ulcer or eczema 9) Who have participated in other clinical trials within the past 3 months 10) Who have a history of drug abuse and alcohol abuse within 5 years prior to clinical trial participation 11) Who have been diagnosed with infertility due to a deformity of the reproductive organs or leiomyoma 12) Others who are considered difficult to perform the clinical trial by the researcher

Design outcomes

Primary

MeasureTime frame
retrieval mature oocyte

Secondary

MeasureTime frame
antral follicle count;anti-mullerian hormon;Depression, Anxiety and Stress Sclaes (DASS-42) score

Countries

Korea, Republic of

Contacts

Public Contactseoyoung You

Pusan National University Hospital

sidrew85@naver.com+82-51-240-7280

Outcome results

None listed

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