Endometrioma Related Reduced Ovarian Reserve

Endometriosis Clinical Trial

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Official title:

The Effect Of The Presence Of Endometriomas On Ovarian Reserve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438735
• Other study ID #: 2015-7/12
• Status: Completed
• Phase: N/A
• First received: May 6, 2015
• Last updated: December 16, 2017
• Start date: April 2015
• Est. completion date: August 1, 2017

Study information

• Verified date: December 2017
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• laparoscopic endometrioma excision

Other:
• Conservative follow up

Locations

Country	Name	City	State
Turkey	Uludag University Scholl of medicine	Bursa	Turkey/bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Uncu G, Kasapoglu I, Ozerkan K, Seyhan A, Oral Yilmaztepe A, Ata B. Prospective assessment of the impact of endometriomas and their removal on ovarian reserve and determinants of the rate of decline in ovarian reserve. Hum Reprod. 2013 Aug;28(8):2140-5. doi: 10.1093/humrep/det123. Epub 2013 Apr 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Anti- mullerian hormone (AMH) level		at recruitment and six months later