Anti-Mullerian Hormone Levels Before and After an Open Myomectomy

Anti-Mullerian Hormone Clinical Trial

Official title:

Anti-Mullerian Hormone Levels Variations Following an Open Myomectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01723085
• Other study ID #: AMH
• Status: Terminated
• Start date: March 2012
• Est. completion date: December 2015

Study information

• Verified date: July 2018
• Source: OVO R & D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. It is well known that ovarian surgery for endometriosis lowers Anti-Mullerian hormone, but little is known for other surgeries. We seek to investigate the hormone variations before and after an open myomectomy.

Hypothesis: Anti-Mullerian hormone levels drop following surgery but return to normal levels in a few months

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• 18 to 42 years old

• Requiring open myomectomy for any indication

Exclusion Criteria:

• Incapable of informed consent

• Use of hormonal contraception or Gonadotropin-releasing hormone agonists in the past 3 months

• Woman over 42 years old

• Post-menopause women

• Positive B-human chorionic gonadotropin the day of surgery

• Ovarian surgery (at the same time)

• Pre-operative AMH below 0.3 ng/mL

Related Conditions & MeSH terms

• Anti-Mullerian Hormone

Locations

Country	Name	City	State
Canada	Hopital Saint-Luc	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
OVO R & D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Mullerian Hormone levels variation	Anti-Mullerian Hormone levels before and 6 months after surgery	6 months