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Completed

NCT Number: NCT02669628

Antimullerian Hormone in Endometriomas

The purpose of this multicenter study is to evaluate the ovarian reserve after alcohol sclerotherapy of endometriomas versus conventional surgery.

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Key information

Conditions

Endometriomas 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

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

About this study

Between 5-10% fertile women are affected by endometriosis, and ovarian endometrioma is present in 17-44% of cases, with 40% of patients with endometriomas being sterile. However, the "gold standard" treatment is laparoscopic ovarian cystectomy and this therapy is associated with a diminished ovarian reserve, with a significant antimullerian hormone (AMH) decrease.

Alcohol sclerotherapy is a new minimal invasive procedure in endometrioma treatment whose potential beneficial effect in fertility preservation is not still demonstrated.

The investigators would like to demonstrate that this procedure improves fertility preservation and reduces morbidity and costs in contrast with conventional surgery. Moreover,the investigators would like to demonstrate that this procedure could be performed in different centers with similar results.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women
  • Age ≥18 and <40 years
  • Unilocular endometrioma according ultrasounds
  • Endometrioma size: 35-100 mm during > 3 months from diagnosis
  • CA125 <200 IU/mL and HE4 < 70,
  • AMH previous surgery between 1.2-4 ng/mL

Exclusion criteria

  • Previous ovarian surgery or gynecological cancer
  • Severe extraovarian endometriosis
  • Dermoid or high risk of malignancy cysts
  • Hormonal treatment 3 months before
  • Pregnancy
  • Mental disability

Treatment and study plan

Surgical technique

Procedure

Laparoscopic surgery

Alcohol sclerotherapy

Procedure

US-guided sclerotherapy

Primary outcomes

  1. AMH Test

    Time frame: 6 months

    the value of AMH after both procedures in ng/mL

Secondary outcomes

  1. antral follicles count

    Time frame: 6 months

    US antral follicles count after both procedures

  2. tumoral markers: epididimal human protein 4 (HE-4) and CA125

    Time frame: 6 months

    the value tumoral markers after both procedures

  3. complications

    Time frame: 1 day

    number of participants with complications

  4. costs

    Time frame: 1 day

    costs (euros) of the procedures and their complications

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Collaborators

  • Roche Diagnostic Ltd.

Registry information

Official study title

Anti-mullerian Hormone in Ovarian Reserve Evaluation After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery. A Pilot Study.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2016
Registry last updated
Feb 23, 2018

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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