ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01287273
Recruitment Status : Unknown
Verified December 2013 by Martha Dirnfeld, Carmel Medical Center.
Recruitment status was:  Recruiting
First Posted : February 1, 2011
Last Update Posted : December 6, 2013
Sponsor:
Information provided by (Responsible Party):
Martha Dirnfeld, Carmel Medical Center

Brief Summary:
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 or disease
Pregnancy In Vitro Fertilization

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.


Study Type : Observational
Estimated Enrollment : 660 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Early Embryos Incubation on Pregnancy Rate in IVF
Study Start Date : April 2011
Estimated Primary Completion Date : February 2014

Group/Cohort
Group A
Transfer at the day of embryo thawing
Group B
Transfer of thawed embryos 24-72 hours post thawing



Primary Outcome Measures :
  1. Pregnancy as measured by blood test for beta hCG [ Time Frame: 12 days following embryos transfer ]
    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 :
  1. Delivery of baby [ Time Frame: 9 mounth after embryos transfer ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 1, 2011    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013

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