Trans-vaginal Aspiration of Small Ovarian Endometrioma. Comparison of Two Different Techniques Before ICSI

Phase 4

• Conditions: Ovarian Endometrioma
• Interventions: Procedure: Transvaginal aspiration; Procedure: transvaginal aspiration and surgicel injection; Drug: Intracytoplasmic sperm injection

• Registration Number: NCT03784404
• Lead Sponsor: Cairo University

Brief Summary

women candidate for ICSI and having ovarian endometrioma smaller than 5 cm will be randomized to either transvaginal aspiration alone or transvaginal aspiration follwed by injection of small parts of oxidized regenerated cellulose within the cyst cavity during the cycle that preceded the induction cycle of ICSI

Detailed Description

women candidate for ICSI and having ovarian endometrioma smaller than 5 cm will be randomized to either transvaginal aspiration alone or transvaginal aspiration follwed by injection of small parts of oxidized regenerated cellulose within the cyst cavity during the cycle that preceded the induction cycle of ICSI.

Transvaginal aspiration will be done under ultrasonographic guidance with spinal needle insertion inside the cyst cavity followed by aspiration of the chocolate material from the cyst \& then irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material. The needle will be withdrawn in women in non-Surgicel group while injection of small pieces of surgicel inside the cyst cavity will be done for women in the surgicel group followed by withdrawal of the needle.

Study Timeline

• Status Verified: 2018-12
• Study Start: 2018-12
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Last Update Submitted: 2018-12-20
• Study First Posted: 2018-12-21
• Last Update Posted: 2018-12-21
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Subfertile women indicated for ICSI
• having a single endometrioma of less than 5 cm with typical sonographic criteria; a cyst with 1 to 4 locules and ground glass appearance of the cyst fluid with no papillary projections and no or minimal vascularization of the cyst capsule. Since endometriotic cysts measuringmore than 1 cm are readily diagnosed by ultrasound,25 we chose a diameter of 2 cm as the lower limit to declare a cyst as endometrioma.
• All cases had a normal uterine cavity demonstrated by ultrasonography and hysteroscopy.

Exclusion Criteria

• bilateral or multiple endometriomas, lesions of more than 5 cm or showing atypical sonographic features presence of uterine pathology (eg, polyp or fibroid)
• follicle-stimulating hormone (FSH) of more than 10,
• body mass index of more than 30, age more than 40 years,
• cases who received previous GnRH therapy for treatment of endometriosis within 12 months of the study
• patients who received oral contraceptive pills or any form of hormones for the previous 3 months,
• patients with previous surgical resection of endometrioma
• severe male factor.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non surgicel group	Transvaginal aspiration	under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material
Non surgicel group	Intracytoplasmic sperm injection	under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material
Surgicel group	transvaginal aspiration and surgicel injection	under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material follwed by insertion of 3-4 pieces of small surgicel inside the cyst cavity
Surgicel group	Intracytoplasmic sperm injection	under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material follwed by insertion of 3-4 pieces of small surgicel inside the cyst cavity

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	14 days after embryo transfer	documentation of intrauterine fetal sac using transvaginal ultrasound

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt