search
Back to results

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
Dansk Fertilitetsklinik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism; Ovarian focused on measuring acupuncture, IVF, AMH, ovarian reserve

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
February 28, 2017
Last Updated
March 15, 2017
Sponsor
Dansk Fertilitetsklinik
search

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

We'll reach out to this number within 24 hrs