The Impact of Early Embryos Incubation on Pregnancy Rate in IVF (IVF-2010)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Martha Dirnfeld, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01287273
First received: January 25, 2011
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

Frozen- thawed embryos obtained by IVF treatments are transferred to the uterus immediately following thawing or after incubation for additional 24-72 hours. The two methods are routine in IVF laboratories. In this study the investigators would like to compare between these two methods in terms of implantation rate, pregnancy rate and delivery.


Condition
Pregnancy
In Vitro Fertilization

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Early Embryos Incubation on Pregnancy Rate in IVF

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Pregnancy as measured by blood test for beta hCG [ Time Frame: 12 days following embryos transfer ] [ Designated as safety issue: Yes ]
    as the usual routine, the women come on day 12 or 13 following embryo transfer to pur IVF unit to get blood teat for beta hCG. When the result show that the beta hCG is above 5 unit/liter we consider it as positive result and the patients is invited for additional blood test 2 days later/


Secondary Outcome Measures:
  • Delivery of baby [ Time Frame: 9 mounth after embryos transfer ] [ Designated as safety issue: Yes ]
    We are routinely report to the Israeli ministry of health all the children who were born from our treatment. In this study we will calculate the number of children per thawed embryo transfer.


Estimated Enrollment: 660
Study Start Date: April 2011
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group A
Transfer at the day of embryo thawing
Group B
Transfer of thawed embryos 24-72 hours post thawing

Detailed Description:

It has been common practice to cryopreserve surplus embryos achieved during IVF treatment or in other situation that embryos are to be preserved for other situations such as suspected ovarian hyper stimulation syndrome, fertility preservation or patient request.

Embryos are usually frozen on day 2, 3 or day 5-6 at the Blastocyst stage. At the time that thawing is planned, patients' cycle is synchronized and prepared either with hormonal treatment or at the natural cycle.

Not all embryos will always survive the thawing and sometimes they will all degenerate.

Embryos that survive the thawing procedure are assessed and replaced on the day of the thaw or left overnight for better selection and will be replaced only if they continue to divide in vitro.

The advantage of embryo transfer on the day of thaw is that embryo exposure in culture is shortened and embryo selection will be occurring in the womb. On the other hand, overnight incubation may avoid transferring embryos that potentially are not able to divide and are biologically not viable.

Although both attitudes are practiced in different IVF centers, at present there are no prospective randomized studies that have been conducted to advise which intervention is better in terms of pregnancy rates.

The purpose of the present study is to assess which technique will result in better pregnancy rates.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

660 IVF patients. patients who are candidates for embryo cryopreservation cycle will be offered to participate in the present prospective randomized study.

After detailed verbal and written explanation on the study protocol they will sign an informed consent and then randomized to 2 groups.

Criteria

Inclusion Criteria:

  • IVF patient who have thawed embryo transfer and can read understand and sigh on informed consent

Exclusion Criteria:

  • IVF patient who have thawed embryo transfer and can not read understand and sigh on informed consent/ also those whos embryos will not survive freezing- thawing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287273

Contacts
Contact: Martha Dirnfeld, MD 8250335 ext 9724 dirnfeld_martha@clalit.org.il
Contact: Shirly Lahav-Baratz, D.Sc 8250118 ext 9724 lahav_shirly@clalit.org.il

Locations
Israel
Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Martha Dirnfeld, MD    8250335 ext 9724    dirnfeld_martha@clalit.org.il   
Contact: Shirly Lahav-Baratz, D.Sc    8250118 ext 9724    lahav_shirly@clalit.org.il   
Principal Investigator: Martha Dirnfeld, MD         
Sponsors and Collaborators
Martha Dirnfeld
Investigators
Principal Investigator: Martha Dirnfeld, MD Carmel Medical Center IVF Unit
  More Information

Publications:
Responsible Party: Martha Dirnfeld, Head of IVF Unit, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01287273     History of Changes
Other Study ID Numbers: CMC-10-0010-CTIL
Study First Received: January 25, 2011
Last Updated: December 5, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
frozen-thawed
IVF
incubation
pregnancy rate
Pregnancy rate of frozen-thawed embryos of IVF treatments

ClinicalTrials.gov processed this record on October 22, 2014