Physical Endometrial Manipulation and Its Effect on ICSI

Study Overview
=================
Brief Summary
-----------------
Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility . Implantation is the main rate limiting step in IVF outcome. Implantation is described at cellular and molecular level by adhesion or fixation of good quality embryo to receptive endometrium within a critical period of time which is called the window of implantation .

Detailed Description
-----------------
Testing the effect of Physical manipulation of the endometrium on the quality of the endometrium prior to ICSI cycle and if it increases the success rate

Official Title
-----------------
Physical Endometrial Manipulation and Its Effect on Success Rate in Patients With Previous ICSI Failure

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

Intervention / Treatment
-----------------
* Device: Hydrotubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile female age 20-35 years Previous Failed one ICSI trial normal basal hormonal profile [FSH, LH] 3-10 mIU/ml and 1.8-8.5 mIU/ml respectively, --normal endometrial cavity patent tubes normal Husband semen analysis Exclusion Criteria: Ovarian factor of infertility Tubal factor of infertility Endometrial factor of infertility Male factor of infertility

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 640 were enrolled but 608 were analyzed
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: manipulation of endometrium<br>The arm is physical manipulation to the endometrium prior to ICSI By one of these interventions )Hydrotubation , Sonohysterography or endometrial scratching | Device: Hydrotubation<br> <br> * Other names: Endometrial scratching;|
| Placebo Comparator: no manipulation to endometrium in ICSI<br>This is the control group , with no manipulation to endometrium prior to ICSI No intervention to this group | Device: Hydrotubation<br> <br> * Other names: Endometrial scratching;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants who achieved clinical pregnancy | Describes how many participant will continue pregnancy after positive pregnancy test | 6 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants who achieved ongoing pregnancy and live birth | Describes who many participant will continue pregnancy till he had birth and a live birth | 9 months after embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICSI - physical - Manipulation - scratching