NCT03830697

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 21, 2019

Status Verified

November 1, 2018

Enrollment Period

3.2 years

First QC Date

December 19, 2018

Last Update Submit

March 20, 2019

Conditions

Poor Ovarian Response

Outcome Measures

Primary Outcomes (1)

  • The number of eggs obtained in the COH cycle.

    The number of eggs obtained in the controlled ovarian hyperstimulation cycle.

    After an average of 13 days in the COH cycle

Secondary Outcomes (3)

  • Ovarian reserve function assessment

    12 week

  • Chinese Medicine Symptoms Scoring Standard for Menstruation

    12 week

  • Self-RatingAnxietyScale

    12 week

Study Arms (2)

Menstruation situation TCM symptom score standard

EXPERIMENTAL
Other: Acupuncture intervention

Sham intervention

PLACEBO COMPARATOR
Other: Acupuncture intervention

Interventions

Acupuncture interventionOTHER

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).

Menstruation situation TCM symptom score standardSham intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • POR compliant diagnostic criteria
  • Intracytoplasmic sperm injection, ICSI）。 Indication with IVF or intracytoplasmic sperm injection (ICSI).
  • ≤age\<40

You may not qualify if:

  • Repeated spontaneous abortion 2 or more patients (including biochemical pregnancy abortion.
  • Patients who have failed to undergo repeated implantation (at least 3 transplanted transplants, at least 3-6 high-quality embryos without clinical pregnancy);
  • 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;
  • Patients and their husbands with abnormal karyotypes (excluding chromosomal polymorphisms;
  • Untreated patients with hydrosalpinx;
  • (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;
  • Refusal to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaanxi Hospital of Traditional Chinese Medicine

Xi'an, Shaanxi, 710003, China

RECRUITING

Central Study Contacts

Su Tongsheng

CONTACT

15929562568chinasuts@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2018

First Posted

February 5, 2019

Study Start

January 1, 2018

Primary Completion

February 28, 2021

Study Completion

December 31, 2021

Last Updated

March 21, 2019

Record last verified: 2018-11

Locations

CN(1)