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

This study has been completed.
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by:
Fertility Center of Las Vegas
ClinicalTrials.gov Identifier:
NCT00963625
First received: August 19, 2009
Last updated: October 8, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention
Infertility
Procedure: Embryo cryopreservation
Procedure: Fresh blastocyst transfer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients

Resource links provided by NLM:


Further study details as provided by Fertility Center of Las Vegas:

Primary Outcome Measures:
  • Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) [ Time Frame: 7 weeks gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ongoing pregnancy at 10 weeks gestation [ Time Frame: 10 weeks gestation ] [ Designated as safety issue: No ]
  • Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts) [ Time Frame: 7 weeks gestation ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.
Active Comparator: Fresh blastocyst transfer.
Transfer of two fresh autologous blastocysts following controlled ovarian stimulation.
Procedure: Fresh blastocyst transfer
Fresh blastocyst transfer following cycle of controlled ovarian stimulation.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • Failure to follow the protocol.
  • Embryo biopsy.
  • Any prior IVF cycle(s).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963625

Locations
United States, Nevada
Fertility Center of Las Vegas
Las Vegas, Nevada, United States, 89117
Sponsors and Collaborators
Fertility Center of Las Vegas
Ferring Pharmaceuticals
Investigators
Principal Investigator: Bruce Shapiro, M.D., Ph.D. Fertility Center of Las Vegas
  More Information

No publications provided by Fertility Center of Las Vegas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruce Shapiro, M.D., Ph.D., Fertility Center of Las Vegas
ClinicalTrials.gov Identifier: NCT00963625     History of Changes
Other Study ID Numbers: SAIRB 07-0014
Study First Received: August 19, 2009
Last Updated: October 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Fertility Center of Las Vegas:
Blastocyst transfer
endometrial receptivity
IVF
in vitro fertilization
embryo cryopreservation

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 22, 2014