The Impact of Early Embryos Incubation on Pregnancy Rate in IVF

Pregnancy Clinical Trial

— IVF-2010  

Official title:

The Impact of Early Embryos Incubation on Pregnancy Rate in IVF

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01287273
• Other study ID #: CMC-10-0010-CTIL
• Status: Recruiting
• Phase: N/A
• First received: January 25, 2011
• Last updated: December 5, 2013
• Start date: April 2011

Study information

• Verified date: December 2013
• Source: Carmel Medical Center
• Contact: Martha Dirnfeld, MD
• Phone: 8250335
• Email: dirnfeld_martha[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• In Vitro Fertilization
• Pregnancy

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Martha Dirnfeld

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes