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

NCT03080584 | Unknown

• 1 other identifier: H-16033980
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism; Ovarian; Female Infertility

Keywords

acupuncture; IVF; AMH; ovarian reserve

Outcome Measures

Primary Outcomes (1)

• AMH

  anti-Müllerian Hormone level

  chance from baseline after 12 weeks of acupuncture

Secondary Outcomes (4)

• No. of oocytes aspirated

  change from baseline treatment and after 12 weeks of acupunture

• FSH dose/oocyte collected

  change from baseline treatment and after 12 weeks of acupuncture

• TQE 44 hours after fertilisation

  change from baseline treatment and after 12 weeks of acupuncture

• biobank with blood plasma

  2 years after treatment completion

Study Arms (1)

acupucture arm

EXPERIMENTAL

all participants undergo 12 weeks of acupuncture

Other: acupuncture

Interventions

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• IVF/ICSI treatment
• years
• AMH measured \< or = 10 pmol/l

You may not qualify if:

• (use of testicular sperm)

Sponsors & Collaborators

• Dansk Fertilitetsklinik: lead

Study Sites (1)

Dansk Fertilitetsklinik

Frederiksberg, 2000, Denmark

RECRUITING

MeSH Terms

Conditions

Hypogonadism; Infertility, Female

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ursula Bentin-Ley, M.D.

  Dansk Fertilitetsklinik

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ursula Bentin-Ley, M.D.

CONTACT

+45 3834 9030; ursula@danfert.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: comparison of AMH and ovarian response before and after acupuncture

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 15, 2017
• Study Start: November 12, 2016
• Primary Completion: March 31, 2018
• Study Completion: June 30, 2018
• Last Updated: March 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)