Effect of 12 Weeks of Acupuncture on AMH and COH in Low Responder Patients
Primary Purpose
Hypogonadism; Ovarian, Female Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism; Ovarian focused on measuring acupuncture, IVF, AMH, ovarian reserve
Eligibility Criteria
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 -
Sites / Locations
- Dansk FertilitetsklinikRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
acupucture arm
Arm Description
all participants undergo 12 weeks of acupuncture
Outcomes
Primary Outcome Measures
AMH
anti-Müllerian Hormone level
Secondary Outcome Measures
No. of oocytes aspirated
the number of oocytes collected during egg aspiration for IVF
FSH dose/oocyte collected
TQE 44 hours after fertilisation
The number of top quality embryos 44 hours after fertilisation
biobank with blood plasma
Full Information
NCT ID
NCT03080584
First Posted
February 28, 2017
Last Updated
March 15, 2017
Sponsor
Dansk Fertilitetsklinik
1. Study Identification
Unique Protocol Identification Number
NCT03080584
Brief Title
Effect of 12 Weeks of Acupuncture on AMH and COH in Low Responder Patients
Official Title
Effect of 12 Weeks of Acupuncture on AMH and Ovarian Reserve in Women With Low Ovarian Reserve. A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 12, 2016 (Actual)
Primary Completion Date
March 31, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dansk Fertilitetsklinik
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism; Ovarian, Female Infertility
Keywords
acupuncture, IVF, AMH, ovarian reserve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
comparison of AMH and ovarian response before and after acupuncture
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acupucture arm
Arm Type
Experimental
Arm Description
all participants undergo 12 weeks of acupuncture
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
12 weeks of acupuncture comprising basic acupuncture, ear acupuncture and Moving cups. On top of the basic acupuncture, additional locations can be added.
Primary Outcome Measure Information:
Title
AMH
Description
anti-Müllerian Hormone level
Time Frame
chance from baseline after 12 weeks of acupuncture
Secondary Outcome Measure Information:
Title
No. of oocytes aspirated
Description
the number of oocytes collected during egg aspiration for IVF
Time Frame
change from baseline treatment and after 12 weeks of acupunture
Title
FSH dose/oocyte collected
Time Frame
change from baseline treatment and after 12 weeks of acupuncture
Title
TQE 44 hours after fertilisation
Description
The number of top quality embryos 44 hours after fertilisation
Time Frame
change from baseline treatment and after 12 weeks of acupuncture
Title
biobank with blood plasma
Time Frame
2 years after treatment completion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ursula Bentin-Ley, M.D.
Phone
+45 3834 9030
Email
ursula@danfert.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Bentin-Ley, M.D.
Organizational Affiliation
Dansk Fertilitetsklinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dansk Fertilitetsklinik
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ursula Bentin-Ley, M.D.
Phone
+45 3834 9030
Email
ursula@danfert.dk
First Name & Middle Initial & Last Name & Degree
Hans Krog, M.D.
Phone
+45 3834 9030
Email
hans@danfert.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of 12 Weeks of Acupuncture on AMH and COH in Low Responder Patients
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