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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01723085
Other study ID # AMH
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03131388 - Clinical Performance Evaluation of AMH Assay
Active, not recruiting NCT00928044 - The Impact of Gynecological Surgery on Ovarian Function in Women of Reproductive Age: Postoperative Changes of Serum Anti-Müllerian Hormone (AMH) N/A