Endometrioma Related Reduced Ovarian Reserve (ERROR)

Bursa Uludag University

Status: Completed

Conditions: Endometriosis

Treatments: Other: Conservative follow up; Procedure: laparoscopic endometrioma excision

Study type: Observational

Funder types: Other

Identifiers

NCT02438735

2015-7/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 3 patient groups

Endometrioma

Description:

Reproductive aged women diagnosed with endometrioma. Conservative follow up for six months.

Treatment:

Other: Conservative follow up

Healthy Controls

Description:

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.

Treatment:

Other: Conservative follow up

Historical controls who underwent surgical excision

Description:

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).

Treatment:

Procedure: laparoscopic endometrioma excision