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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03080584
Other study ID # H-16033980
Secondary ID
Status Recruiting
Phase N/A
First received February 28, 2017
Last updated March 15, 2017
Start date November 12, 2016
Est. completion date June 30, 2018

Study information

Verified date March 2017
Source Dansk Fertilitetsklinik
Contact Ursula Bentin-Ley, M.D.
Phone +45 3834 9030
Email ursula@danfert.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 30, 2018
Est. primary completion date March 31, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Denmark Dansk Fertilitetsklinik Frederiksberg

Sponsors (1)

Lead Sponsor Collaborator
Dansk Fertilitetsklinik

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary AMH anti-Müllerian Hormone level chance from baseline after 12 weeks of acupuncture
Secondary No. of oocytes aspirated the number of oocytes collected during egg aspiration for IVF change from baseline treatment and after 12 weeks of acupunture
Secondary FSH dose/oocyte collected change from baseline treatment and after 12 weeks of acupuncture
Secondary TQE 44 hours after fertilisation The number of top quality embryos 44 hours after fertilisation change from baseline treatment and after 12 weeks of acupuncture
Secondary biobank with blood plasma 2 years after treatment completion
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