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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00963625
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : October 13, 2010
Ferring Pharmaceuticals
Information provided by:
Fertility Center of Las Vegas

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

Condition or disease Intervention/treatment Phase
Infertility Procedure: Embryo cryopreservation Procedure: Fresh blastocyst transfer Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients
Study Start Date : October 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) [ Time Frame: 7 weeks gestation ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00963625

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bruce Shapiro, M.D., Ph.D., Fertility Center of Las Vegas Identifier: NCT00963625     History of Changes
Other Study ID Numbers: SAIRB 07-0014
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: October 2010

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

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