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

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.

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 660

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 34362
    • Recruiting
    • Carmel Medical Center
    • Contact: Martha Dirnfeld, MD; Phone Number: 9724 8250335; Email: dirnfeld_martha@clalit.org.il
    • Contact: Shirly Lahav-Baratz, D.Sc; Phone Number: 9724 8250118; Email: lahav_shirly@clalit.org.il
    • Principal Investigator: Martha Dirnfeld, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy as measured by blood test for beta hCG	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/	12 days following embryos transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivery of baby	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.	9 mounth after embryos transfer

Collaborators and Investigators

• Sponsor: Martha Dirnfeld
• Investigators: Principal Investigator: Martha Dirnfeld, MD, Carmel Medical Center IVF Unit

Publications and helpful links

General Publications

• Lahav-Baratz S, Koifman M, Shiloh H, Ishai D, Wiener-Megnazi Z, Dirnfeld M. Analyzing factors affecting the success rate of frozen-thawed embryos. J Assist Reprod Genet. 2003 Nov;20(11):444-8. doi: 10.1023/b:jarg.0000006705.46147.a2.
• Lahav-Baratz S, Shiloh H, Koifman M, Kraiem Z, Wiener-Megnazi Z, Ishai D, Dirnfeld M. Early embryo-endometrial signaling modulates the regulation of matrix metalloproteinase-3. Fertil Steril. 2004 Oct;82 Suppl 3:1029-35. doi: 10.1016/j.fertnstert.2004.06.026.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 31, 2011
• First Posted (Estimate): February 1, 2011

Study Record Updates

• Last Update Posted (Estimate): December 6, 2013
• Last Update Submitted That Met QC Criteria: December 5, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: IVF; pregnancy rate; incubation; frozen-thawed; Pregnancy rate of frozen-thawed embryos of IVF treatments
• Other Study ID Numbers: CMC-10-0010-CTIL