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CompletedNCT00963625Updated Oct 13, 2010

Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients

An interventional study of Embryo cryopreservation and Fresh blastocyst transfer in Infertility, sponsored by Fertility Center of Las Vegas. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-10-13.

Sponsored by Fertility Center of Las Vegas · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders.

Read the detailed description

The purpose of this study is to determine if blastocyst transfers in cycles of post-thaw extended culture (PTEC) have different efficacy than transfers of fresh blastocysts in patients with expected normal response to ovarian stimulation.

Multiple studies have found altered endometrial histology and gene expression following controlled ovarian stimulation.

PTEC cycles require cryopreservation of the entire 2pn oocyte cohort in the prior cycle. Once thawed, the embryos are cultured to the blastocyst stage before transfer.

In typical cycles using frozen-thawed embryos, many thawed embryos that appear to survive do not actually resume and continue development. PTEC ensures the transfer of embryos that resumed development and continued developing at least to the blastocyst stage (4-5 days post-thaw).

The viability of a blastocyst in a PTEC cycle has been shown to be on par with that of a fresh blastocyst. Therefore, comparing outcomes of blastocyst transfers in PTEC cycles with that in fresh autologous cycles allows the potential endometrial impact of controlled ovarian stimulation to be assessed.

02

Conditions studied

  • Infertility

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Keywords

  • Blastocyst transfer
  • endometrial receptivity
  • IVF
  • in vitro fertilization
  • embryo cryopreservation
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Fertility Center of Las Vegas is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female patient 18 to 40 years of age seeking their first IVF treatment.
  • Cycle day 3 FSH less than 10.0 IU/l.
  • 8 to 15 antral follicles observed on ultrasound.

Exclusion criteria

Exclusion Criteria:

  • Failure to follow the protocol.
  • Embryo biopsy.
  • Any prior IVF cycle(s).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Blastocyst transfer in PTEC cycle

    Transfer of two blastocysts derived from thawed bipronuclear oocytes that were subject to post-thaw extended culture (PTEC).

    Procedure: Embryo cryopreservation

  • Active comparator
    Fresh blastocyst transfer.

    Transfer of two fresh autologous blastocysts following controlled ovarian stimulation.

    Procedure: Fresh blastocyst transfer

Interventions

  • ProcedureEmbryo cryopreservation

    Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.

  • ProcedureFresh blastocyst transfer

    Fresh blastocyst transfer following cycle of controlled ovarian stimulation.

06

What researchers measure

Primary outcomes

  1. Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)

    Time frame: 7 weeks gestation

Secondary outcomes

  1. Ongoing pregnancy at 10 weeks gestation

    Time frame: 10 weeks gestation

  2. Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)

    Time frame: 7 weeks gestation

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Study locations

1 site
  • Fertility Center of Las Vegas
    Las Vegas, Nevada 89117, United States
08

References and documents

Publications

  • Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3. PubMed 33539543 ↗
  • Shapiro BS, Daneshmand ST, Bedient CE, Garner FC. Comparison of birth weights in patients randomly assigned to fresh or frozen-thawed embryo transfer. Fertil Steril. 2016 Aug;106(2):317-21. doi: 10.1016/j.fertnstert.2016.03.049. Epub 2016 Jul 7. PubMed 27397626 ↗
  • Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C, Thomas S. Evidence of impaired endometrial receptivity after ovarian stimulation for in vitro fertilization: a prospective randomized trial comparing fresh and frozen-thawed embryo transfer in normal responders. Fertil Steril. 2011 Aug;96(2):344-8. doi: 10.1016/j.fertnstert.2011.05.050. Epub 2011 Jul 6. PubMed 21737072 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00963625
Lead sponsor
Fertility Center of Las Vegas
Collaborators
Ferring Pharmaceuticals
First posted
Aug 21, 2009
Start date
Oct 2007
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Oct 13, 2010

Study contacts

Bruce Shapiro, M.D., Ph.D.
principal investigator · Fertility Center of Las Vegas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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