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Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes

Primary Purpose

Infertility

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

ultrasound guided aspiration of hydrosalpingeal fluid

About this trial

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

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

Ahmed Elgazzar hospital , Assisted conception unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1: Hydrosalpinx needle aspiration

2. no aspiration

Arm Description

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 .

IVF-ET is done without prior aspiration of hydrosalpingeal fluid

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .

Full Information

NCT ID

NCT01040351

First Posted

December 28, 2009

Last Updated

July 29, 2011

Sponsor

Cairo University

Collaborators

Ahmed Elgazzar Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01040351

Brief Title

Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes

Official Title

Effect of Ultrasound Guided Aspiration of Hydrosalpingeal Fluid at the Time of Oocyte Retrieval on the Outcomes of IVF-ET, a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cairo University

Collaborators

Ahmed Elgazzar Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 .

Detailed Description

A Cochrane review of prospective randomized 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 and previous multiple laparotomies. Other less invasive options for patients with hydrosalpinges as ultrasound guided aspiration of hydrosalpingeal fluid, antibiotics 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. 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 .

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1: Hydrosalpinx needle aspiration

Arm Type

Experimental

Arm Description

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 .

Arm Title

2. no aspiration

Arm Type

No Intervention

Arm Description

IVF-ET is done without prior aspiration of hydrosalpingeal fluid

Intervention Type

Procedure

Intervention Name(s)

ultrasound guided aspiration of hydrosalpingeal fluid

Other Intervention Name(s)

ultrasound guided Hydrosalpinx needle aspiration

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.

Primary Outcome Measure Information:

Title

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

Description

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

Description

The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) 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

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

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ahmed M sayed, MD,PhD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

Ahmed Elgazzar hospital , Assisted conception unit

City

Giza

State/Province

35 Eleshreen st. King Faisal.

ZIP/Postal Code

12111

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

18343810

Citation

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.

Results Reference

background

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

derived

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Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes

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