NCT01040351

Brief Summary

The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2006

Typical duration for phase_2

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

October 1, 2006

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 29, 2011

Completed
Last Updated

August 29, 2011

Status Verified

October 1, 2010

Enrollment Period

3.3 years

First QC Date

December 28, 2009

Results QC Date

May 10, 2010

Last Update Submit

July 29, 2011

Conditions

Infertility

Keywords

InfertilityHydrosalpinxIVF-ET

Outcome Measures

Primary Outcomes (1)

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

    The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound )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)

1: Hydrosalpinx needle aspiration

EXPERIMENTAL

After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .

Procedure: ultrasound guided aspiration of hydrosalpingeal fluid

2. no aspiration

NO INTERVENTION

IVF-ET is done without prior aspiration of hydrosalpingeal fluid

Interventions

ultrasound guided aspiration of hydrosalpingeal fluidPROCEDURE

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 guided Hydrosalpinx needle aspiration
1: Hydrosalpinx needle aspiration

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)

Ahmed Elgazzar hospital , Assisted conception unit

Giza, 35 Eleshreen Saint King Faisal., 12111, Egypt

Location

Related Publications (2)

  • Hammadieh N, Coomarasamy A, Ola B, Papaioannou S, Afnan M, Sharif K. Ultrasound-guided hydrosalpinx aspiration during oocyte collection improves pregnancy outcome in IVF: a randomized controlled trial. Hum Reprod. 2008 May;23(5):1113-7. doi: 10.1093/humrep/den071. Epub 2008 Mar 13.

    PMID: 18343810BACKGROUND

  • 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: 20672903DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Limitations and Caveats

Several patients refused to participate in the study

Results Point of Contact

Title
Usama M.Fouda, M.D, PhD
Organization
Cairo university
umfrfouda@yahoo.com
+20123595106

Study Officials

  • Usama M Fouda, M.D, PhD

    Lecturer of obstetrics and Gynecology , Faculty of medicine ,Cairo university.

    STUDY CHAIR

  • Ahmed M sayed, MD,PhD

    Assistant professor of obstetrics and Gynecology , Faculty of medicine ,Cairo university.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2009

First Posted

December 29, 2009

Study Start

October 1, 2006

Primary Completion

February 1, 2010

Study Completion

May 1, 2010

Last Updated

August 29, 2011

Results First Posted

August 29, 2011

Record last verified: 2010-10

Locations

EG(1)