Endometrioma Related Reduced Ovarian Reserve

Completed

• Conditions: Endometriosis
• Interventions: Other: Conservative follow up; Procedure: laparoscopic endometrioma excision

• Registration Number: NCT02438735
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-08
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-16
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endometrioma	Conservative follow up	Reproductive aged women diagnosed with endometrioma. Conservative follow up for six months.
Historical controls who underwent surgical excision	laparoscopic endometrioma 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).
Healthy Controls	Conservative follow up	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.

Primary Outcome Measures

Name	Time	Method
Change in Serum Anti- mullerian hormone (AMH) level	at recruitment and six months later

Trial Locations

Locations (1)

Uludag University Scholl of medicine; 🇹🇷 Bursa, Turkey/bursa, Turkey