NCT02008240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

2.5 years

First QC Date

December 8, 2013

Last Update Submit

February 16, 2015

Conditions

Infertility

Keywords

InfertilityHydrosalpinxIVF-ETSalpingectomy

Outcome Measures

Primary Outcomes (1)

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

    5 weeks after embryo transfer

Secondary Outcomes (1)

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

    18 weeks after embryo transfer

Study Arms (2)

Needle aspiration of hydrosalpinx

EXPERIMENTAL

Aspiration of hydrosalpingeal fluid under ultrasound guidance

Procedure: Needle aspiration of hydrosalpinx

salpingectomy

ACTIVE COMPARATOR

Surgical removal of hydrosalpinx

Procedure: Salpingectomy

Interventions

Needle aspiration of hydrosalpinxPROCEDURE

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.

Also known as: ultrasound guidance aspiration of hydrosalpingeal fluid
Needle aspiration of hydrosalpinx
SalpingectomyPROCEDURE

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 .

Also known as: surgical removal of hydrosalpinx
salpingectomy

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aljazeera (Al Gazeera) hospital

Giza, Giza Governorate, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 20672903BACKGROUND

  • 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.

    PMID: 10548619BACKGROUND

  • 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.

    PMID: 25783650DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Salpingectomy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Usama M. Fouda, M.D, PhD

    Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university , and scientific director of assisted conception unit, Aljazeera (Al Gazeera) hospital.

    STUDY CHAIR

  • Ahmed M. Sayed, M.D, PhD

    Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university, and clinical director of assisted conception unit, Aljazeera (Al Gazeera) hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D , PhD

Study Record Dates

First Submitted

December 8, 2013

First Posted

December 11, 2013

Study Start

August 1, 2011

Primary Completion

February 1, 2014

Study Completion

May 1, 2014

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

EG(1)