Effect of 12 Weeks of Acupuncture on AMH and COH in Low Responder Patients

March 15, 2017 updated by: Ursula Bentin-Ley, Dansk Fertilitetsklinik

Effect of 12 Weeks of Acupuncture on AMH and Ovarian Reserve in Women With Low Ovarian Reserve. A Pilot Study

the investigators want to study whether 12 weeks of acupuncture has any effect on AMH and the ovarian reserve in women with low ovarian reserve (low responders). AMH is measured before and after 12 weeks of acupuncture and the clinical response to controlled ovarian hyperstimulation before and after the acupuncture is compared.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

AMH is measured cycle day 2 or 3 before and after 12 weeks of acupuncture and the levels are compared. Furthermore, secondary outcomes from IVF treatments before and after the intervention are compared.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 2000
        • Recruiting
        • Dansk Fertilitetsklinik
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • IVF/ICSI treatment
  • 18-40 years
  • AMH measured < or = 10 pmol/l
  • maximum of 8 oocytes collected at last treatment before inclusion-

Exclusion Criteria:

  • (use of testicular sperm)
  • more than 4 acupuncture treatments within the last 3 months before inclusion -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: acupucture arm
all participants undergo 12 weeks of acupuncture
Other: acupuncture
12 weeks of acupuncture comprising basic acupuncture, ear acupuncture and Moving cups. On top of the basic acupuncture, additional locations can be added.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMH
Time Frame: chance from baseline after 12 weeks of acupuncture
anti-Müllerian Hormone level
chance from baseline after 12 weeks of acupuncture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
No. of oocytes aspirated
Time Frame: change from baseline treatment and after 12 weeks of acupunture
the number of oocytes collected during egg aspiration for IVF
change from baseline treatment and after 12 weeks of acupunture
FSH dose/oocyte collected
Time Frame: change from baseline treatment and after 12 weeks of acupuncture
change from baseline treatment and after 12 weeks of acupuncture
TQE 44 hours after fertilisation
Time Frame: change from baseline treatment and after 12 weeks of acupuncture
The number of top quality embryos 44 hours after fertilisation
change from baseline treatment and after 12 weeks of acupuncture
biobank with blood plasma
Time Frame: 2 years after treatment completion
2 years after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dansk Fertilitetsklinik

Investigators

  • Principal Investigator: Ursula Bentin-Ley, M.D., Dansk Fertilitetsklinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2016

Primary Completion (Anticipated)

March 31, 2018

Study Completion (Anticipated)

June 30, 2018

Study Registration Dates

First Submitted

February 28, 2017

First Submitted That Met QC Criteria

March 14, 2017

First Posted (Actual)

March 15, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-16033980

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Female Infertility

Clinical Trials on acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe