Effect of 12 Weeks of Acupuncture on AMH and COH in Low R... | NCT03080584

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

NCT03080584

Sponsor

Dansk Fertilitetsklinik

Status

Unknown status

Last Update Posted

Mar 16, 2017Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Hypogonadism; Ovarian
Female Infertility

Interventions

acupuncture

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 12, 2016Actual

Primary Completion Date

Mar 31, 2018Estimated

Completion Date

Jun 30, 2018Estimated

First Submitted Date

Feb 28, 2017

First Submission Date that Met QC Criteria

Mar 14, 2017

First Posted Date

Mar 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2017

Last Update Posted Date

Mar 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
acupucture arm	Experimental	all participants undergo 12 weeks of acupuncture	Other: acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acupuncture	Other	12 weeks of acupuncture comprising basic acupuncture, ear acupuncture and Moving cups. On top of the basic acupuncture, additional locations can be added.	acupucture arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AMH	anti-Müllerian Hormone level	chance from baseline after 12 weeks of acupuncture

Secondary Outcomes

Measure	Description	Time Frame
No. of oocytes aspirated	the number of oocytes collected during egg aspiration for IVF	change from baseline treatment and after 12 weeks of acupunture
FSH dose/oocyte collected		change from baseline treatment and after 12 weeks of acupuncture

Other Outcomes

Not provided

Eligibility Module

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 -

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ursula Bentin-Ley, M.D.	Contact	+45 3834 9030		ursula@danfert.dk

Overall Officials

Name	Affiliation	Role
Ursula Bentin-Ley, M.D.	Dansk Fertilitetsklinik	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dansk Fertilitetsklinik	Recruiting	Frederiksberg		2000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007006	Hypogonadism
D007247	Infertility, Female

Ancestor Terms

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015670	Acupuncture Therapy

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided