Physical Endometrial Manipulation and Its Effect on ICSI

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345251
• Other study ID #: Algazeerah
• Status: Completed
• Phase: N/A
• Start date: January 3, 2017
• Est. completion date: December 28, 2017

Study information

• Verified date: August 2021
• Source: Aljazeera Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: December 28, 2017
• Est. primary completion date: December 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Hydrotubation

Locations

Country	Name	City	State
Egypt	Algazeerah	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Aljazeera Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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