Clinical trial NCT01287273: The Impact of Early Embryos Incubation on Pregnancy Rate in IVF
Official title: The Impact of Early Embryos Incubation on Pregnancy Rate in IVF
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
In Vitro Fertilization
Keywords: frozen-thawed
IVF
incubation
pregnancy rate
Pregnancy rate of frozen-thawed embryos of IVF treatments
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2011-02-01
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Pregnancy as measured by blood test for beta hCG
timeFrame: 12 days following embryos transfer
Secondary outcomes:
measure: Delivery of baby
timeFrame: 9 mounth after embryos transfer
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center IVF Unit
name: Martha Dirnfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/j.fertnstert.2004.06.026.