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Completed

NCT Number: NCT02438735

Endometrioma Related Reduced Ovarian Reserve

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Uludag University Scholl of medicine

Bursa, Turkey/bursa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic endometrioma excision

Procedure

Conservative follow up

Other

Primary outcomes

  1. Change in Serum Anti- mullerian hormone (AMH) level

    Time frame: at recruitment and six months later

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

The Effect Of The Presence Of Endometriomas On Ovarian Reserve

Acronym: ERROR

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 8, 2015
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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