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

Primary Purpose

Ovarian Endometrioma

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Transvaginal aspiration
transvaginal aspiration and surgicel injection
Intracytoplasmic sperm injection
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Endometrioma

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Kasr Alainy medical school

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Non surgicel group

Surgicel group

Arm 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

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

Outcomes

Primary Outcome Measures

clinical pregnancy rate
documentation of intrauterine fetal sac using transvaginal ultrasound

Secondary Outcome Measures

Full Information

First Posted
December 20, 2018
Last Updated
December 20, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03784404
Brief Title
Trans-vaginal Aspiration of Small Ovarian Endometrioma. Comparison of Two Different Techniques Before ICSI
Official Title
Trans-vaginal Aspiration With or Without Injection of Surgicel for Treatment of Small Ovarian Endometrioma Before ICSI Cycles. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Endometrioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non surgicel group
Arm Type
Active Comparator
Arm 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
Arm Title
Surgicel group
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Transvaginal aspiration
Intervention 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
Intervention Type
Procedure
Intervention Name(s)
transvaginal aspiration and surgicel injection
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Intracytoplasmic sperm injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
clinical pregnancy rate
Description
documentation of intrauterine fetal sac using transvaginal ultrasound
Time Frame
14 days after embryo transfer

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged, MD
Phone
+201005227404
Email
prof.ahmedmaged@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
fadel shaltout, MD
Phone
+201006023073
Email
dr.shaltout@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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