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

Female Infertility Clinical Trial

Official title:

Effect of 12 Weeks of Acupuncture on AMH and Ovarian Reserve in Women With Low Ovarian Reserve. A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03080584
• Other study ID #: H-16033980
• 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
• 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 -

Related Conditions & MeSH terms

• Female Infertility
• Hypogonadism
• Hypogonadism; Ovarian
• Infertility
• Infertility, Female

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