NCT01778621

Brief Summary

Acupuncture at follicular phase of the cycle may improve the pregnancy rate. This study aims to compare assisted reproduction outcome between two groups of PCOS patients underwent IVF, one group received acupuncture and other group without acupuncture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

January 23, 2013

Last Update Submit

July 19, 2019

Conditions

PCOS

Keywords

AcupunctureAMHPCOS

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate.

    Increase in pregnancy rate

    13 months

Secondary Outcomes (1)

  • Ongoing pregnancy rate

    15 months

Study Arms (2)

Acupuncture (Hwato®)

EXPERIMENTAL

30-40 minutes acupuncture at certain acupoints that chosen according to traditional Chinese medicine and included LIV3,SP6,SP8,ST36,SP10,ST29,LI14,Ren 04;starting at follicular phase of the cycle till 2 days before oocyte picked up.

Device: Acupuncture(Hwato®)

No acupuncture

NO INTERVENTION

No intervention was done for this group of patients.

Interventions

Acupuncture(Hwato®)DEVICE

acupuncture using 4cm long disposable stainless steel hair-thin needles manufactured by Suzhou medical appliance factory (China).

Acupuncture (Hwato®)

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS patients with patent one or two fallopian tubes, normal uterine cavity and partners with normal semen parameters.
  • infertility
  • years
  • IVF treatment -

You may not qualify if:

  • patients with disorders that have the similar clinical presentation
  • closed both tubes
  • abnormal semen parameters
  • intracytoplasmic sperm injection (ICSI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assisted Reproduction Center, Department of Obstetrics and Gynecology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Study Officials

  • Ying Gao, Ph.D., M.D.

    Assisted Reproduction Center, Union Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor /assissted reproduction center/Union Hospital

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 29, 2013

Study Start

March 1, 2011

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

July 23, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)