The Impact of Early Embryos Incubation on Pregnancy Rate in IVF

NCT ID: NCT01287273

Last Updated: 2013-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 660 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30

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.

Conditions

Pregnancy; In Vitro Fertilization

Keywords

frozen-thawed; IVF; incubation; pregnancy rate; Pregnancy rate of frozen-thawed embryos of IVF treatments

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

Transfer at the day of embryo thawing

No interventions assigned to this group

Group B

Transfer of thawed embryos 24-72 hours post thawing

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Martha Dirnfeld

OTHER

Sponsor Role: lead

Responsible Party

Martha Dirnfeld

Head of IVF Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Martha Dirnfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center IVF Unit

Locations

Carmel Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Martha Dirnfeld, MD

Role: CONTACT

Phone: 8250335

Email: dirnfeld_martha@clalit.org.il

Shirly Lahav-Baratz, D.Sc

Role: CONTACT

Phone: 8250118

Email: lahav_shirly@clalit.org.il

Facility Contacts

Martha Dirnfeld, MD

Role: primary

Shirly Lahav-Baratz, D.Sc

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 14714822 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15474069 (View on PubMed)

Other Identifiers

CMC-10-0010-CTIL

Identifier Type: -

Identifier Source: org_study_id