NCT03572608

Brief Summary

This study evaluates the effectiveness of acupuncture on pregnancy success before embryo transfer in IVF treatment in female infertile patients. Half of participants will receive acupuncture sessions before embryo transfer, while the other half will not receive.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 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

First Submitted

Initial submission to the registry

May 28, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

May 28, 2018

Last Update Submit

June 19, 2018

Conditions

Keywords

acupunctureinfertilitypregnancy

Outcome Measures

Primary Outcomes (1)

  • pregnancy

    positive betaHCG

    2 weeks after the treatment

Secondary Outcomes (1)

  • Anxiety level

    Through study completion, 2 weeks after the protocol

Study Arms (2)

Acupuncture Treatment

EXPERIMENTAL

Acupuncture group will receive 3 acupuncture sessions. The first session will be one week before embryo transfer. The second session will be 30 minute before embryo transfer. And the last session will be 30 minute after embryo transfer.

Other: Acupuncture treatment

Control Group

NO INTERVENTION

Control Group will not receive any acupuncture session before or after embryo transfer.

Interventions

Classical acupuncture points will be used without a formal traditional Chinese medicine diagnosis in the intervention group. Neither manual needle stimulation nor moxibustion will used. The needles will left in place for 30 min and de qi was not sought. The points will be selected bilateral Heart-7, bilateral Large Intestine-4, Governing Vessel-20 and ear shenmen for the first session. Bilateral Conception Vessel-3,4,6, bilateral Liver-3, bilateral Stomach-30, bilateral Spleen-6, bilateral Governing Vessel-20 will be used for the second session. Bilateral Large Intestine-4, bilateral Spleen-6,9, bilateral Stomach-36 will be used for the last session. All acupuncture points will be selected and localized on the basis of the WHO Standardised Acupuncture Point Location.

Acupuncture Treatment

Eligibility Criteria

Age23 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsself-representation
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • To have unexplained infertility
  • To go in vitro fertilization treatment
  • To give permission by informed consent form

You may not qualify if:

  • Below age of 18 and above age of 45
  • To have secondary infertility
  • To reject completing informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Hospital

Erzurum, 25040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility, FemaleInfertility

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Bunyamin Borekci

    Ataturk University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Yasemin Cayir

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 28, 2018

Study Start

June 1, 2018

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations