NCT02683967

Brief Summary

The trial aims to investigate whether acupuncture has an effect in increasing clinical pregnancy (pregnancy that is confirmed by a scan) and live birth rates on women undergoing IVF treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

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

November 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

2.2 years

First QC Date

January 11, 2016

Last Update Submit

February 12, 2016

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    The primary objective is to determine the clinical effectiveness of acupuncture in improving live birth rates in women undergoing IVF

    18 months

Secondary Outcomes (3)

  • Clinical pregnancy rate

    18 months

  • Multiple pregnancy

    9 months

  • Quality of life

    9 months

Study Arms (2)

Acupuncture

ACTIVE COMPARATOR

These patients received acupuncture during the follicular development phase and on the day of egg collection.

Procedure: acupuncture

Control

NO INTERVENTION

Patients received standard care, no acupuncture.

Interventions

acupuncturePROCEDURE

patients received a Delphi acupuncture at least 3 times during their fertility treatment cycle.

Acupuncture

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women under the age of 43 years with a BMI of less than 30 undergoing 1st or no more than their 2nd failed fresh IVF or ICSI cycle.

You may not qualify if:

  • Those women undergoing frozen embryo replacement cycle or receiving donor eggs, BMI \> 30 or currently having acupuncture/ any other form of CAM, having contraindication to acupuncture like those with HIV, Hep C will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Karin Gillerman

    NHS Honorary Contract

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2016

First Posted

February 17, 2016

Study Start

November 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 17, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share