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

Sponsor
Dansk Fertilitetsklinik (Other)
Overall Status
Unknown status
CT.gov ID
NCT03080584
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
19.5
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: acupuncture
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
comparison of AMH and ovarian response before and after acupuncturecomparison of AMH and ovarian response before and after acupuncture
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of 12 Weeks of Acupuncture on AMH and Ovarian Reserve in Women With Low Ovarian Reserve. A Pilot Study
Actual Study Start Date :
Nov 12, 2016
Anticipated Primary Completion Date :
Mar 31, 2018
Anticipated Study Completion Date :
Jun 30, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. AMH [chance from baseline after 12 weeks of acupuncture]

    anti-Müllerian Hormone level

Secondary Outcome Measures

  1. No. of oocytes aspirated [change from baseline treatment and after 12 weeks of acupunture]

    the number of oocytes collected during egg aspiration for IVF

  2. FSH dose/oocyte collected [change from baseline treatment and after 12 weeks of acupuncture]

  3. TQE 44 hours after fertilisation [change from baseline treatment and after 12 weeks of acupuncture]

    The number of top quality embryos 44 hours after fertilisation

  4. biobank with blood plasma [2 years after treatment completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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 -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dansk Fertilitetsklinik Frederiksberg Denmark 2000

Sponsors and Collaborators

  • Dansk Fertilitetsklinik

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ursula Bentin-Ley, Physician, Dansk Fertilitetsklinik
ClinicalTrials.gov Identifier:
NCT03080584
Other Study ID Numbers:
  • H-16033980
First Posted:
Mar 15, 2017
Last Update Posted:
Mar 16, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ursula Bentin-Ley, Physician, Dansk Fertilitetsklinik
acupuncture
IVF
AMH
ovarian reserve
Additional relevant MeSH terms:
Infertility
Infertility, Female
Hypogonadism

Study Results

No Results Posted as of Mar 16, 2017