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OpenTrials
Completed

NCT Number: NCT04461899

Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy

Endometriosis affects 6-10% of women in childbearing age. It is a heterogeneous disease with three different forms: superficial endometriosis (peritoneal), ovarian endometrioma and deep pelvic endometriosis (subperitoneal).

Surgical management of endometriomas is justified in cases of significant clinical symptoms (like pain), especially in cases of resistance to medical treatment. Currently, laparoscopic cystectomy surgery is the recommended technique to treat ovarian endometrioma. However, it is now well demonstrated that this surgery significantly reduces the ovarian reserve.

Ethanol sclerotherapy is an alternative technique used to treat ovarian endometriomas. Several studies demonstrated the effectiveness and safety of this treatment, particularly in terms of preserving fertility. Regarding these reassuring data, many clinicians changed their practices and propose this technique as a first-line surgery.

Ovarian reserve comprises two elements: size of the primordial follicle stock and quality of the ovocytes. Antimüllerian hormone (AMH) has been shown to be the best marker of fertility.

The aim of this study is to observe changes in AMH levels after endometrioma sclerotherapy. This study is conducted in the Hospices Civils de Lyon, in 3 different sites.

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Key information

Conditions

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

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Femme Mère Enfant, Bron, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient in childbearing age from 18 to 42 years.
  • Patient with uni- or bilateral endometrioma(s) without clinical and ultrasound criteria for ovarian carcinoma.
  • A sclerotherapy is programmed.
  • Patient affiliated to a social security scheme.
  • Patient who gave consent for this research.

Exclusion criteria

  • doubt about the endometriotic origin of the cyst
  • suspect malignant ovarian disease.
  • Pregnant or breastfeeding patient.
  • Patient participating in other research with an exclusion period still in progress at the time of inclusion or those included in interventional research that interferes with the study protocol.
  • Patient deprived of liberty by judicial or administrative decision.
  • Patient (≥ 18 years old) under legal protection or unable to give consent.
  • Patient does not speak French.

Treatment and study plan

blood test

Biological

additional blood test will be done 3 and 12 months after endometrioma sclerotherapy.

Primary outcomes

  1. AMH level

    Time frame: 3 months (+/-15 days) after endometrioma sclerotherapy

Secondary outcomes

  1. AMH level

    Time frame: 12 months (+/-15 days) after endometrioma sclerotherapy

  2. AMH level

    Time frame: 12 months after endometrioma sclerotherapy

    AMH level 3 and 12 months after endometrioma sclerotherapy

  3. Endometrioma recurrence

    Time frame: 3 months (+/-15 days) after endometrioma sclerotherapy

    New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple

  4. Endometrioma recurrence

    Time frame: 12 months (+/-15 days) after endometrioma sclerotherapy

    New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ENDOPAL AMH

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 8, 2020
Registry last updated
Sep 25, 2023

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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