Physical Endometrial Manipulation and Its Effect on ICSI

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Device: Hydrotubation

• Registration Number: NCT03345251
• Lead Sponsor: Aljazeera Hospital

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

Study Timeline

• Study Start: 2017-01-03
• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-17
• Primary Completion: 2017-12-25
• Study Completion: 2017-12-28
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-28
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 640

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manipulation of endometrium	Hydrotubation	The arm is physical manipulation to the endometrium prior to ICSI By one of these interventions )Hydrotubation , Sonohysterography or endometrial scratching
no manipulation to endometrium in ICSI	Hydrotubation	This is the control group , with no manipulation to endometrium prior to ICSI No intervention to this group

Primary Outcome Measures

Name	Time	Method
The number of participants who achieved clinical pregnancy	6 weeks after embryo transfer	Describes how many participant will continue pregnancy after positive pregnancy test

Secondary Outcome Measures

Name	Time	Method
The number of participants who achieved ongoing pregnancy and live birth	9 months after embryo transfer	Describes who many participant will continue pregnancy till he had birth and a live birth

Trial Locations

Locations (1)

Algazeerah; 🇪🇬 Giza, Egypt