Endometrioma Related Reduced Ovarian Reserve

NCT02438735 | Completed

• 1 other identifier: 2015-7/12
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

ovarian endometriomas; AMH; ovarian reserve

Outcome Measures

Primary Outcomes (1)

• Change in Serum Anti- mullerian hormone (AMH) level

  at recruitment and six months later

Study Arms (3)

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

Interventions

laparoscopic endometrioma excision PROCEDURE

Historical controls who underwent surgical excision

Conservative follow up OTHER

Endometrioma; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludag University Scholl of medicine

Bursa, Turkey/bursa, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 23624580 BACKGROUND

• Kasapoglu I, Ata B, Uyaniklar O, Seyhan A, Orhan A, Yildiz Oguz S, Uncu G. Endometrioma-related reduction in ovarian reserve (ERROR): a prospective longitudinal study. Fertil Steril. 2018 Jul 1;110(1):122-127. doi: 10.1016/j.fertnstert.2018.03.015. Epub 2018 Jun 20.

  PMID: 29935810 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Anti-mullerian hormone (AMH)

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

• gürkan uncu

  Uludag University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.md

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 8, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Locations

TU (1)