NCT01040247

Brief Summary

Women undergoing in vitro fertilization (IVF) therapy, who are low responder and agree to enter the trial will be randomized to a study group, for whom embryo transfer will be done on the same day as oocyte aspiration and fertilization; and a control group for whom embryo transfer will be performed 48 to 72 hours later, as is the current accepted practice.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

December 28, 2009

Last Update Submit

June 21, 2015

Conditions

Keywords

InfertilityLow ResponderIVFEmbryo Transfer

Outcome Measures

Primary Outcomes (1)

  • Pregnancy

    14 days

Study Arms (2)

Day 0 Embryo Transfer

EXPERIMENTAL

Embryo transfer will be performed on the same day as oocyte aspiration and fertilization

Other: Embryo Transfer

Day 2,3 Embryo Transfer

ACTIVE COMPARATOR

Embryo Transfer will be performed 2 or 3 days after oocyte aspiration and fertilization

Other: Embryo Transfer

Interventions

In the study group embryo transfer will be performed on the day of oocyte aspiration and fertilization while in the control group it will be done 2 or 3 days later as is common practice.

Day 0 Embryo TransferDay 2,3 Embryo Transfer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing IVF
  • Number of mature oocytes equal to or lesser than the maximum number of embryos intended for transfer

You may not qualify if:

  • Patient nor consenting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmek Medical Center

Afula, Israel

Location

MeSH Terms

Conditions

Infertility

Interventions

Embryo Transfer

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician

Study Record Dates

First Submitted

December 28, 2009

First Posted

December 29, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations