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Conservative Endometrioma Surgery

ConditionsEndometriosis OvaryEndometrioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation.

The 2 conservatives techniques used are:

1. The combined technique 2. CO2 laser vaporization only

Ovarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 - 40 years (both inclusive)

Unilateral endometriotic cysts with a mean diameter of >=2.5cm and ≤8 cm, measured in 3 dimensions.

Presence of a contralateral endometrioma of ≤ 2cm is allowed

Complaining of infertility and/or pain

Disqualifiers

Incomplete surgery for the pelvis

Contra-indication for the use of contraception (combined or Progesteron only)

Use of GnRH analogues preoperatively and in the first 3 months postoperatively

(History of) hysterectomy

Trial design

Design model

Crossover

Treatments tested in this trial

  • Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).

    Procedure/Surgery

    cf. different arms

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: The combined techniqueActive comparator 1 intervention
Group B: CO2 laser vaporization onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

AMH levels 3 months postoperatively

To assess the effect of conservative laparoscopic treatment of endometrioma(s) on ovarian reserve as reflected by AMH in patients planned for laparoscopic CO2 laser surgery. For the primary outcome evaluation of serum AMH will be done before (baseline) and after (at 3 months follow up) laparoscopic treatment of endometrioma(s).

Time frame
3 months postoperatively

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

GZA Ziekenhuizen Campus Sint-Augustinus

Collaborator

Centre Hospitalier Régional de la Citadelle

Collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborator

Source ClinicalTrials.gov
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