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A Trial Study on Acupuncture Treatment of Poor Ovarian Response

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ClinicalTrials.gov Identifier: NCT03830697
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
NorthWest Women and Children Hospital
Information provided by (Responsible Party):
Shaanxi Hospital of Traditional Chinese Medicine

Brief Summary:
The trial was completed by Shaanxi Provincial Hospital of Traditional Chinese Medicine and Northwest Women and Children's Hospital. Thirty-five patients with POR who underwent ART (Assisted Reproductive) treatment were observed in each center. Patients in the experimental group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good COH timing during acupuncture treatment, she will enter the COH cycle at any time. Patients in the control group waited for 12 weeks before COH. In this study, the COH regimen of the two groups of patients was the same, and the appropriate ovulation induction protocol was selected by the investigator according to the B-ultrasound and endocrine conditions of the patient's menstrual day 1-3. At the end of treatment, patients were observed for the number of eggs in the COH cycle, fertilization rate, cleavage rate, available embryo rate, high quality embryo rate, implantation rate, ovarian reserve function assessment, menstrual status and peri-menopausal symptoms.

Condition or disease Intervention/treatment Phase
Poor Ovarian Response Other: Acupuncture intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Trial Was Completed by Shaanxi Provincial Hospital of Traditional Chinese Medicine and Northwest Women and Children's Hospital. Thirty-five Patients With POR Who Underwent ART (Assisted Reproductive) Treatment Were Observed in Each Center. Patients in the Experimental Group Were Given Acupuncture Treatment for 12 Weeks Prior to COH. If the Patient Has a Good COH Timing During Acupuncture Treatment, She Will Enter the COH Cycle at Any Time. Patients in the Control Group Waited for 12 Weeks Before COH
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Menstruation situation TCM symptom score standard Other: Acupuncture intervention
Patients in the experimental group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good COH timing during acupuncture treatment, he or she will enter the COH cycle at any time.The acupuncture intervention program of the test group is as follows:Acupoint group 1: Baihui(DU20), Zhongyu(RN12), Tianshu (ST25)(bilateral), Guanyuan(RN4), uterus (bilateral)(EX-CA1), Dahe(KI12) (bilateral),Zusanli (ST36)(bilateral), Sanyinjiao(SP6) (bilateral), Taichong (LR3)(both sides).

Placebo Comparator: Sham intervention Other: Acupuncture intervention
Patients in the experimental group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good COH timing during acupuncture treatment, he or she will enter the COH cycle at any time.The acupuncture intervention program of the test group is as follows:Acupoint group 1: Baihui(DU20), Zhongyu(RN12), Tianshu (ST25)(bilateral), Guanyuan(RN4), uterus (bilateral)(EX-CA1), Dahe(KI12) (bilateral),Zusanli (ST36)(bilateral), Sanyinjiao(SP6) (bilateral), Taichong (LR3)(both sides).




Primary Outcome Measures :
  1. The number of eggs obtained in the COH cycle. [ Time Frame: After an average of 13 days in the COH cycle ]
    The number of eggs obtained in the controlled ovarian hyperstimulation cycle.


Secondary Outcome Measures :
  1. Ovarian reserve function assessment [ Time Frame: 12 week ]
    Basal sinus follicle count AFC, AMH and basal hormone levels (package)Including FSH, LH and E2)

  2. Chinese Medicine Symptoms Scoring Standard for Menstruation [ Time Frame: 12 week ]
    Menstrual situation:Mainly assess the menstrual cycle and menstrual flow. menstrual cycle is based on the results of the patient's own comparison.Divided into normal cycle, early menstruation (>7 days before menstruation) and delayed menstruation (>7 days after menstruation) 3class. According to the patient's own comparison results, the menstrual volume is divided into normal menstruation and less menstrual flow.Reduce, or the menstrual period is less than 2 days, or even a drop. It is generally believed that the amount of menstruation is less than 20ml for less menstruation.Class 2.

  3. Self-RatingAnxietyScale [ Time Frame: 12 week ]
    Menstrual disorders, less menstrual flow, hot flashes, night sweats or cold, convulsions, forgetfulness, irritability Insomnia, secondary symptoms include dizziness, tinnitus, dull complexion, waist and knee pain, itchy skin, low libido.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. POR compliant diagnostic criteria
  2. Intracytoplasmic sperm injection, ICSI)。 Indication with IVF or intracytoplasmic sperm injection (ICSI).

3.18≤age<40

Exclusion Criteria:

  1. Repeated spontaneous abortion 2 or more patients (including biochemical pregnancy abortion.
  2. Patients who have failed to undergo repeated implantation (at least 3 transplanted transplants, at least 3-6 high-quality embryos without clinical pregnancy);
  3. uterine malformation (single uterus, double uterus, double uterus, untreated mediastinal uterus) and other effects affecting uterine cavity disease (adenomyosis, submucosal uterine fibroids, intrauterine adhesions and scar uterus) Patient;
  4. Patients and their husbands with abnormal karyotypes (excluding chromosomal polymorphisms;
  5. Untreated patients with hydrosalpinx;
  6. (6)Patients with contraindications to ART and pregnancy, or those with a clear influence on pregnancy, such as hypertension, clinically symptomatic heart disease, diabetes, liver disease, kidney disease, severe anemia, history of venous thrombosis, History of pulmonary embolism or cerebrovascular events, history of malignant tumors;
  7. Refusal to sign the informed consent form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830697


Contacts
Contact: Su Tongsheng 15929562568 chinasuts@126.com

Locations
China, Shaanxi
Shaanxi Hospital of Traditional Chinese Medicine Recruiting
Xi'an, Shaanxi, China, 710003
Contact: Tong sheng Su, M.D.    008615929562568    chinasuts@126.com   
Principal Investigator: Tong Sheng Su, M.D.         
Sponsors and Collaborators
Shaanxi Hospital of Traditional Chinese Medicine
NorthWest Women and Children Hospital

Responsible Party: Shaanxi Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03830697     History of Changes
Other Study ID Numbers: 2018-11-29
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No