Cleave-stage Transfer on Day 3 Versus Day 5 Transfer When... | NCT04210414

Studies
Cleave-stage Transfer on Day 3 Versus Day 5 Transfer When Only One Embryo Available

NCT04210414

Sponsor

Ibn Sina Hospital

Status

Terminated

Last Update Posted

Jun 15, 2022Actual

Enrollment

83Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

Embryo transfer

Countries

Egypt

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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID19 Pandemic affected recruitment across 2020 and the stringent inclusion criteria makes the proposed sample size to be likely unachievable in reasonable period.

Expanded Access Info

Start Date

Jan 10, 2020Actual

Primary Completion Date

Nov 10, 2021Actual

Completion Date

Nov 10, 2021Actual

First Submitted Date

Dec 21, 2019

First Submission Date that Met QC Criteria

Dec 21, 2019

First Posted Date

Dec 24, 2019Actual

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

Jun 12, 2022

Last Update Posted Date

Jun 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Muhammad Fawzy, IVF Lab Director, Ibn Sina HospitalPrincipal Investigator

Lead Sponsor

Ibn Sina HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

When only one embryo is available after in vitro fertilization, the option is to transfer either day 3 or day 5. There is no randomized trial compared the day 3 to day 5 for this subgroup.

Detailed Description

Recruitment is very slow. The TSC will discuss termination next meeting with the DMC.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Day 3 transfer	Experimental	Transfer on day 3 when only one embryo is available	Other: Embryo transfer
Day 5 transfer	Experimental	Transfer on day 5 when only one embryo is available	Other: Embryo transfer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Embryo transfer	Other	Transfer of only one embryo	Day 3 transfer Day 5 transfer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ongoing pregnancy rate		within 20 weeks of gestation

Secondary Outcomes

Measure	Description	Time Frame
Biochemical pregnancy rate		One month
clinical pregnancy		7 weeks of gestation
Embryo development after In vitro fertilization cycle

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infertile couple with only one embryo available for transfer

Exclusion Criteria:

ineligible for study

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qena Fertility Center		Qina	Qena Governorate	123456	Egypt
Banon Assiut

IPD Sharing Statement Module

Plan to Share IPD

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

Intervention Browse Module

MeSH Terms

ID	Term
D004624	Embryo Transfer

Ancestor Terms

ID	Term
D027724	Reproductive Techniques, Assisted
D012099	Reproductive Techniques
D013812	Therapeutics
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided