Physical Endometrial Manipulation and Its Effect on ICSI

Aljazeera Hospital

Status: Completed

Conditions: Infertility

Treatments: Device: Hydrotubation

Study type: Interventional

Funder types: Other

Identifiers

NCT03345251

Algazeerah

Details and patient eligibility

About

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 .

Full 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

Enrollment: 640 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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640 participants in 2 patient groups, including a placebo group

manipulation of endometrium

Experimental group

Description:

The arm is physical manipulation to the endometrium prior to ICSI By one of these interventions )Hydrotubation , Sonohysterography or endometrial scratching

Treatment:

Device: Hydrotubation

no manipulation to endometrium in ICSI

Placebo Comparator group

Description:

This is the control group , with no manipulation to endometrium prior to ICSI No intervention to this group

Treatment:

Device: Hydrotubation