Site of Embryo Transfer in Intracytoplasmic Sperm Injection | NCT05004922

Studies
Site of Embryo Transfer in Intracytoplasmic Sperm Injection

NCT05004922

Sponsor

National Research Centre, Egypt

Status

Unknown status

Last Update Posted

Aug 13, 2021Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Infertility

Interventions

Embryo transfer into upper cavity
Embryo transfer into midcavity

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Estimated

Primary Completion Date

Jan 1, 2022Estimated

Completion Date

Feb 1, 2022Estimated

First Submitted Date

Feb 3, 2019

First Submission Date that Met QC Criteria

Aug 11, 2021

First Posted Date

Aug 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2021

Last Update Posted Date

Aug 13, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sherif Elsirgany, Researcher ,Family Planning and Reproductive Health Department, National Research Centre, EgyptPrincipal Investigator

Lead Sponsor

National Research Centre, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The technique of embryo transfer is thought to affect the implantation and pregnancy rate .At present, the implantation site can be estimated from the location of the very early gestational sac by transvaginal ultrasound.

Detailed Description

Many authors claimed that an increase in implantation and pregnancy rates has been reported to occur when embryos are transferred to the central area of the uterine cavity but there are no studies about the implantation site after using this type of transfer.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICSI in upper cavity		Embryo transfer into the upper cavity	Other: Embryo transfer into upper cavity
ICSI in midcavity		Embryo transfer into the midcavity	Other: Embryo transfer into midcavity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Embryo transfer into upper cavity	Other	Transfer of embryos in upper cavity	ICSI in upper cavity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of women who will get pregnant in each group	how many women will get pregnant after ICSI in every group	within one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1- AVF uterus. 2- BMI less than 30

Exclusion Criteria:

1- RVF uterus. 2- BMI more than 30.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

women with infertility who will undergo ICSI

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

infertile women

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherif Elsirgany, M.D	Contact	+201223607191		sherifelsirgany@yahoo.com

Overall Officials

Name	Affiliation	Role
Sherif Elsirgany, M.D	Researcher, Family planning and Reproductive Health Department, NRC, Egypt	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided