Physical Endometrial Manipulation and Its Effect on ICSI

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03345251

Enrollment

640

Registered

2017-11-17

Start date

2017-01-03

Completion date

2017-12-28

Last updated

2021-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

ICSI - physical - Manipulation - scratching

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

Interventions

DEVICEHydrotubation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Outcomes Assessor)

Intervention model description

640 were enrolled but 608 were analyzed

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026