Prospective Interventional Study on Ovarian Function Preservation by Endometrioma Ablation Using the Thulium YAG Laser

JRCT ID: jRCT1052230182

Registered date:15/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Ovarian Endometrioma
• Date of first enrollment: 15/02/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Cystectomy is performed for endometrioma with the desire to fertility. Cystectomy improves the natural pregnancy rate but does not improve the pregnancy rate in assisted reproductive technology. Ablation surgery using the Tulium-YAG laser will be performed instead of Cystectomy.

Outcome(s)

• Primary Outcome: Change in serum AMH
• Secondary Outcome: Serum CA125 changes, ablation depth, surgical outcomes, recurrence rates, and pregnancy rates

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 43age old
• Gender: Female

Include criteria

Patients with endometrioma who have been diagnosed as infertile, for whom surgery is indicated and for whom infertility treatment is covered by insurance.
1) Patients scheduled for abdominal or laparoscopic surgery
2) premenopausal women
3) Between 20 and 43 years of age at the time of consent.
4) The patient has the capacity to consent and is able to give written consent of her own free will.
5) ECOG-PS1 or lower.
(ECOG-PS1 means that the patient is limited in strenuous activities, but can walk and perform light or sedentary tasks.)
Patients who are eligible for surgery and whose postoperative infertility treatment is covered by insurance are selected.

Exclude criteria

Exclude those that are known to affect serum AMH levels.
1) Those who have used sex hormones within 4 weeks prior to obtaining consent
2) Those with a history of surgery for endometriosis
3) Who have been diagnosed with a malignant tumor
4) Pregnant women or those who may be pregnant or breastfeeding
5) Patients who are judged by the principal investigator and subinvestigators to be unsuitable for this study.

Related Information

• Primary Sponsor: Kawahara Naoki