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

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Ovarian Endometrioma

Treatments: Procedure: transvaginal aspiration and surgicel injection; Drug: Intracytoplasmic sperm injection; Procedure: Transvaginal aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT03784404

45

Details and patient eligibility

About

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

Full 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 The needle will be withdrawn in women in non-Surgicel group while injection of small pieces of surgicel inside the cyst cavity will be done for women in the surgicel group followed by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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Non surgicel group

Active Comparator group

Description:

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

Treatment:

Drug: Intracytoplasmic sperm injection

Procedure: Transvaginal aspiration

Surgicel group

Active Comparator group

Description:

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

Treatment:

Drug: Intracytoplasmic sperm injection

Procedure: transvaginal aspiration and surgicel injection