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

NCT ID: NCT03080584

Last Updated: 2017-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-12

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Hypogonadism; Ovarian Female Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

comparison of AMH and ovarian response before and after acupuncture
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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acupucture arm

all participants undergo 12 weeks of acupuncture

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

12 weeks of acupuncture comprising basic acupuncture, ear acupuncture and Moving cups. On top of the basic acupuncture, additional locations can be added.

Interventions

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acupuncture

12 weeks of acupuncture comprising basic acupuncture, ear acupuncture and Moving cups. On top of the basic acupuncture, additional locations can be added.

Intervention Type OTHER

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dansk Fertilitetsklinik

OTHER

Sponsor Role lead

Responsible Party

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Ursula Bentin-Ley

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ursula Bentin-Ley, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dansk Fertilitetsklinik

Locations

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Dansk Fertilitetsklinik

Frederiksberg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Ursula Bentin-Ley, M.D.

Role: CONTACT

+45 3834 9030

Facility Contacts

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Ursula Bentin-Ley, M.D.

Role: primary

+45 3834 9030

Hans Krog, M.D.

Role: backup

+45 3834 9030

Other Identifiers

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H-16033980

Identifier Type: -

Identifier Source: org_study_id

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