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Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Needle aspiration of hydrosalpinx
Salpingectomy
Sponsored by
Aljazeera Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, Hydrosalpinx, IVF-ET, Salpingectomy

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with unilateral or bilateral hydrosalpinges visible by ultrasound
  • Age between 18 - 37 years
  • Period of infertility > 1 year
  • Body mass index between 19-29
  • Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations.
  • Normal recent semen analysis (according to World Health Organization criteria).

Exclusion Criteria:

  • Uterine fibroid requiring surgical removal.
  • Endometriosis.
  • Male factor of infertility requiring ICSI, Previous IVF cycles.
  • History of recurrent miscarriage.
  • Endocrinologic disorders.
  • Presence of systemic disease contraindicating pregnancy.

Sites / Locations

  • Aljazeera (Al Gazeera) hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Needle aspiration of hydrosalpinx

salpingectomy

Arm Description

Aspiration of hydrosalpingeal fluid under ultrasound guidance

Surgical removal of hydrosalpinx

Outcomes

Primary Outcome Measures

The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle

Secondary Outcome Measures

The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .

Full Information

First Posted
December 8, 2013
Last Updated
February 16, 2015
Sponsor
Aljazeera Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02008240
Brief Title
Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET
Official Title
Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET.A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aljazeera Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET.
Detailed Description
The adverse impact of hydrosalpinx on in vitro fertilisation embryo transfer (IVF-ET) outcomes has been confirmed by several retrospective and prospective studies . Cochrane review of prospective randomised trials of laparoscopic salpingectomy confirmed the beneficial effect of laparoscopic salpingectomy on IVF-ET outcomes in patients with hydrosalpinges. Surgery is not usually safe especially in patients with extensive adhesions, morbid obesity or previous multiple laparotomies. Furthermore, many infertile couples refuse to undergo bilateral salpingectomy or proximal tubal occlusion because these procedures remove any hope of spontaneous pregnancy. Other less invasive options for patients with hydrosalpinges as ultrasound-guided aspiration of hydrosalpingeal fluid, antibiotics (alone or combined with aspiration) and hysteroscopic occlusion of fallopian tube were studied in order to find an alternative to salpingectomy . Although these methods are simple and getting popular, current data are inadequate to recommend these treatment options instead of salpingectomy because most of the supporting evidences for these methods come from small retrospective studies. A recent randomized controlled trial revealed that the aspiration of hydrosalpingeal fluid at the time of oocyte retrieval was associated with improved implantation rate and pregnancy rates. The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Hydrosalpinx, IVF-ET, Salpingectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Needle aspiration of hydrosalpinx
Arm Type
Experimental
Arm Description
Aspiration of hydrosalpingeal fluid under ultrasound guidance
Arm Title
salpingectomy
Arm Type
Active Comparator
Arm Description
Surgical removal of hydrosalpinx
Intervention Type
Procedure
Intervention Name(s)
Needle aspiration of hydrosalpinx
Other Intervention Name(s)
ultrasound guidance aspiration of hydrosalpingeal fluid
Intervention Description
Under deep sedation, the retrieval of oocytes is done and then an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . If there are bilateral hydrosalpinges, the process is repeated on the opposite side.
Intervention Type
Procedure
Intervention Name(s)
Salpingectomy
Other Intervention Name(s)
surgical removal of hydrosalpinx
Intervention Description
laparoscopic surgical removal of affected tube is done with bipolar electrocoagulation for hemostasis. The mesosalpinx is coagulated as close a possible to the fallopian tube to avoid any compromise in the ovarian blood supply . In cases with marked adhesion, proximal ligation and a distal fenestration is done .
Primary Outcome Measure Information:
Title
The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle
Time Frame
5 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .
Time Frame
18 weeks after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with unilateral or bilateral hydrosalpinges visible by ultrasound Age between 18 - 37 years Period of infertility > 1 year Body mass index between 19-29 Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations. Normal recent semen analysis (according to World Health Organization criteria). Exclusion Criteria: Uterine fibroid requiring surgical removal. Endometriosis. Male factor of infertility requiring ICSI, Previous IVF cycles. History of recurrent miscarriage. Endocrinologic disorders. Presence of systemic disease contraindicating pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Usama M. Fouda, M.D, PhD
Organizational Affiliation
Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university , and scientific director of assisted conception unit, Aljazeera (Al Gazeera) hospital.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed M. Sayed, M.D, PhD
Organizational Affiliation
Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university, and clinical director of assisted conception unit, Aljazeera (Al Gazeera) hospital
Official's Role
Study Director
Facility Information:
Facility Name
Aljazeera (Al Gazeera) hospital
City
Giza
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
20672903
Citation
Fouda UM, Sayed AM. Effect of ultrasound-guided aspiration of hydrosalpingeal fluid during oocyte retrieval on the outcomes of in vitro fertilisation-embryo transfer: a randomised controlled trial (NCT01040351). Gynecol Endocrinol. 2011 Aug;27(8):562-7. doi: 10.3109/09513590.2010.507290. Epub 2010 Jul 30.
Results Reference
background
PubMed Identifier
10548619
Citation
Strandell A, Lindhard A, Waldenstrom U, Thorburn J, Janson PO, Hamberger L. Hydrosalpinx and IVF outcome: a prospective, randomized multicentre trial in Scandinavia on salpingectomy prior to IVF. Hum Reprod. 1999 Nov;14(11):2762-9. doi: 10.1093/humrep/14.11.2762.
Results Reference
background
PubMed Identifier
25783650
Citation
Fouda UM, Sayed AM, Abdelmoty HI, Elsetohy KA. Ultrasound guided aspiration of hydrosalpinx fluid versus salpingectomy in the management of patients with ultrasound visible hydrosalpinx undergoing IVF-ET: a randomized controlled trial. BMC Womens Health. 2015;15:21. doi: 10.1186/s12905-015-0177-2. Epub 2015 Feb 27.
Results Reference
derived

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Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET

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