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Endometrioma Related Reduced Ovarian Reserve (ERROR)

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ClinicalTrials.gov Identifier: NCT02438735
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
GÜRKAN UNCU,PROF. MD, Uludag University

Brief Summary:
Prior studies have shown surgical excision of endometriomas are associated with a decline in ovarian reserve as assessed by serum anti-Mullerian Hormone (AMH) levels. However, the natural history of serum AMH levels in the presence of untreated endometriomas are unknown. Purpose of this study is to determine whether the presence of endometriomas cause a faster decline in serum AMH levels than in healthy women over a six months period.

Condition or disease Intervention/treatment
Endometriosis Procedure: laparoscopic endometrioma excision Other: Conservative follow up

Detailed Description:
The study is a prospective cohort study. Women diagnosed with endometriomas by transvaginal or transabdominal ultrasound or MRI will be recruited from a tertiary care endometriosis clinic. Age matched healthy controls will be recruited from the staff of the same hospital. A priorly published historical group of women who underwent endometrioma excision will be a second comparator.

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect Of The Presence Of Endometriomas On Ovarian Reserve
Study Start Date : April 2015
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 1, 2017

Group/Cohort Intervention/treatment
Endometrioma
Reproductive aged women diagnosed with endometrioma. Conservative follow up for six months.
Other: Conservative follow up
Healthy Controls

Women with regular menstrual cycles and without ovarian pathology will be recruited from physicians, nurses and other staff of the same hospital.

Controls will be matched for age with the women in the endometrioma group. They will be conservatively followed up for six months.

Other: Conservative follow up
Historical controls who underwent surgical excision
20 women who underwent surgical excision of endometrioma in the same clinic had serum AMH levels measured preoperatively and on post operative sixth month. Their values will be compared with that of endometrioma group. These data were priorly published in detail (Uncu et al. 2013).
Procedure: laparoscopic endometrioma excision



Primary Outcome Measures :
  1. Change in Serum Anti- mullerian hormone (AMH) level [ Time Frame: at recruitment and six months later ]

Biospecimen Retention:   Samples Without DNA
Serum Anti-mullerian hormone (AMH)


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The decision to include a healthy control group was taken five months after starting recruitment of women with endometrioma. Only 12 women with endometriomas had been recruited until then and none of them had six month serum AMH level measured.

Since healthy controls were reluctant to undergo transvaginal ultrasound examination, antral follicle counts were not measured as another marker of ovarian reserve for healthy controls and some women in the endometrioma group.

Criteria

Inclusion Criteria:

  • Reproductive age
  • Endometrioma without indication for surgery or treatment with combined contraceptive, progestin or other hormonal intervention.

Exclusion Criteria:

  • Menstrual cycle irregularity
  • Polycystic ovarian syndrome
  • Women who were pregnant or contemplating pregnancy in the next six months
  • History of ovarian surgery
  • Using medication which could affect ovarian function during six months before recruitment
  • Indication for surgical excision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438735


Locations
Turkey
Uludag University Scholl of medicine
Bursa, Turkey/bursa, Turkey
Sponsors and Collaborators
Uludag University
Investigators
Study Director: gürkan uncu Uludag University School of Medicine

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GÜRKAN UNCU,PROF. MD, prof.md, Uludag University
ClinicalTrials.gov Identifier: NCT02438735     History of Changes
Other Study ID Numbers: 2015-7/12
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Keywords provided by GÜRKAN UNCU,PROF. MD, Uludag University:
ovarian endometriomas
AMH
ovarian reserve

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female