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Optimal Timing For Embryo Transfer For Low Responder Patients

Primary Purpose

Infertility

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Embryo Transfer
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, Low Responder, IVF, Embryo Transfer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient nor consenting

Sites / Locations

  • HaEmek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Day 0 Embryo Transfer

Day 2,3 Embryo Transfer

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pregnancy

Secondary Outcome Measures

Full Information

First Posted
December 28, 2009
Last Updated
June 21, 2015
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT01040247
Brief Title
Optimal Timing For Embryo Transfer For Low Responder Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruiting patients
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Low Responder, IVF, Embryo Transfer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Day 0 Embryo Transfer
Arm Type
Experimental
Arm Description
Embryo transfer will be performed on the same day as oocyte aspiration and fertilization
Arm Title
Day 2,3 Embryo Transfer
Arm Type
Active Comparator
Arm Description
Embryo Transfer will be performed 2 or 3 days after oocyte aspiration and fertilization
Intervention Type
Other
Intervention Name(s)
Embryo Transfer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pregnancy
Time Frame
14 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient undergoing IVF Number of mature oocytes equal to or lesser than the maximum number of embryos intended for transfer Exclusion Criteria: Patient nor consenting
Facility Information:
Facility Name
HaEmek Medical Center
City
Afula
Country
Israel

12. IPD Sharing Statement

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Optimal Timing For Embryo Transfer For Low Responder Patients

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