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

NCT03784404 | Unknown Phase 4 DMC

• 1 other identifier: 45
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Ovarian Endometrioma

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  documentation of intrauterine fetal sac using transvaginal ultrasound

  14 days after embryo transfer

Study Arms (2)

Non surgicel group

ACTIVE COMPARATOR

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

Procedure: Transvaginal aspiration; Drug: Intracytoplasmic sperm injection

Surgicel group

ACTIVE COMPARATOR

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

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

Interventions

Transvaginal aspiration PROCEDURE

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

transvaginal aspiration and surgicel injection PROCEDURE

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 DRUG

Candidates for the standard long protocol received triptorelin 0.1 mg Subcutanous daily starting from day 21 of the previous cycle. On the second day of the stimulation cycle, pituitary downregulation was confirmed. Controlled ovarian stimulation was then started on day 3 using Human Menopausal Gonadotropin (Menogon; Ferring). The dose of gonadotropin was individualized. The patients were monitored with serial ultrasound and serum E2. When at least 3 follicles reached 18 mm, ovulation was triggered using Human Chorionic Gonadotropin 10000 IU (Epifasi 10000 IU; Eipico, Tenth of Ramadan, Egypt) IM and ovum pickup was performed 35 hours later. All cases received luteal support in the form of progesterone 400 mg twice daily. Embryo transfer was done on day 3 or 5 using Labotect semi-rigid catheter (Labotect GmbH, Kassel area, Germany) under abdominal ultrasound guidance.

Non surgicel group; Surgicel group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Surgicel; Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Ahmed Maged, MD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+201005227404; prof.ahmedmaged@gmail.com

fadel shaltout, MD

CONTACT

+201006023073; dr.shaltout@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 21, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

EG (1)