Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes

Study Overview
=================
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 .

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

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: ultrasound guided aspiration of hydrosalpingeal fluid


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Hydrosalpinx needle aspiration<br>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<br>* 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.<br>* Other names: ultrasound guided Hydrosalpinx needle aspiration;|
| No Intervention: 2. no aspiration<br>IVF-ET is done without prior aspiration of hydrosalpingeal fluid | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | 18 weeks after embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, Hydrosalpinx, IVF-ET