NCT00736411

Brief Summary

The aim of this investigation is to determine the value of combining acupuncture with infertility patients undergoing In Vitro Fertilization (IVF). The investigators will measure the outcomes of endometrial lining, uterine blood flow, hormones, stress levels, and pregnancy and live birth rates.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

2.2 years

First QC Date

August 13, 2008

Last Update Submit

October 27, 2015

Conditions

Keywords

infertilityIVFacupuncture

Outcome Measures

Primary Outcomes (1)

  • pregnancy

    week 10 of study

Secondary Outcomes (1)

  • uterine blood flow

    final measurement in week 8

Study Arms (2)

1

ACTIVE COMPARATOR

IVF

Procedure: IVF

II

OTHER

treatment

Procedure: acupuncture

Interventions

acupuncturePROCEDURE

16 treatments over 8 weeks

II
IVFPROCEDURE

one 4 week IVF cycle

1

Eligibility Criteria

Age21 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • females between 21 and 42 years old
  • primary or secondary infertility
  • no more than 2 previously failed IVF cycles
  • undergoing IVF
  • FSH \< 11

You may not qualify if:

  • FSH \> 11
  • using an egg donor
  • using PGD
  • using heparin or lovanox protocols
  • estradiol level less than 20 or over 80
  • taking herbal therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pacific Fertility Center

San Francisco, California, 94133, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Caylie J See, L.Ac.

    Pacific Fertility Center

    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

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 15, 2008

Study Start

August 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations