NCT03994614

Brief Summary

Patients in experimental group will be given transcutaneous electrical acupoint stimulation (TEAS) treatment for 12 weeks prior to controlled ovarian stimulation (COS).The patients will be given three times acupuncture every week except menstruation.Patients in no intervention group will not be given any interventions for 12 weeks prior to COS. The primary outcome measure is the number of MII eggs obtained in the COS cycle. The secondary outcome measures are the lab and clinical reproductive outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 2, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

April 2, 2019

Last Update Submit

March 31, 2022

Conditions

Poor Ovarian Response

Keywords

transcutaneous electrical acupoint stimulationquality of oocyteovarian reservepoor ovarian responsein vitro fertilization-embryo transfer

Outcome Measures

Primary Outcomes (1)

  • The number of MII eggs

    The number of MII eggs obtained in the COS cycle

    one day after oocyte pickup

Secondary Outcomes (10)

  • Basic Follicle stimulating hormone （FSH） value

    On Day two of menstruation

  • Basic Luteinizing hormone （LH） value

    On Day two of menstruation

  • Basic estrodiol value

    On Day two of menstruation

  • Serum AMH value

    On Day two of menstruation

  • antral follicle count

    antral follicle count On Day two of menstruation

  • +5 more secondary outcomes

Study Arms (2)

the TEAS intervention group

EXPERIMENTAL

Patients in this group will be given TEAS treatment for 12 weeks prior to COS.

Other: TEAS

No intervention group

NO INTERVENTION

Patients in this group will not be given any interventions for 12 weeks prior to COS.

Interventions

TEASOTHER

Patients in the experimental group will be given TEAS treatment for 12 weeks prior to COS. The patients will be given three times acupuncture every week except menstruation. The acupuncture acupoint locations are as follows: head acupoint Baihui(DU20), abdominal acupoint Zhongji (RN3), Guanyuan (RN4), Zigong(EX-CA1), leg acupoint Sanyinjiao(SP6), waist acupoint Shenyu (BL23) and Guanyuanyu(BL26).

the TEAS intervention group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The poor ovarian response patients compliance with Bologna consensus
  • Age：20-45 year
  • Women undergoing IVF-ET because of infertility for more than one year.

You may not qualify if:

  • Patients with genital tract malformation. 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)
  • Complicated with other medical diseases（Hypertension, diabetes, psychosis, hereditary diseases）

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

Study Officials

  • Wenbi Zhang, doctor

    Fudan University

    PRINCIPAL INVESTIGATOR

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

April 2, 2019

First Posted

June 21, 2019

Study Start

January 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

April 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)