Comparison of Transfers of Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Fertility Center of Las Vegas
Sponsor:
Information provided by (Responsible Party):
Bruce Shapiro M.D., Fertility Center of Las Vegas
ClinicalTrials.gov Identifier:
NCT01247987
First received: November 23, 2010
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine if cryopreservation at the blastocyst stage followed by embryo thaw and transfer is as effective as cryopreservation of bipronuclear oocytes followed by post-thaw extended culture (PTEC), and blastocyst transfer. Effectiveness will be measured by the rate of ongoing pregnancy at 10 weeks gestation.


Condition Intervention
Infertility
Procedure: Blastocyst cryopreservation
Procedure: Bipronuclear oocyte cryopreservation

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 Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Ongoing pregnancy rate [ Time Frame: 10 weeks gestation ] [ Designated as safety issue: No ]
    Ultrasonically confirmed fetal heart motion at 10 weeks gestation


Estimated Enrollment: 140
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Blastocyst cryopreservation
Subjects randomly assigned to this arm of the study will have all of their embryos cryopreserved at the blastocyst stage, followed by thaw and transfer in a subsequent menstrual cycle.
Procedure: Blastocyst cryopreservation
Embryos cryopreserved at the blastocyst stage
Experimental: Bipronuclear oocyte cryopreservation
Subjects randomly assigned to this arm of the study will have all of their bipronuclear oocytes cryopreserved, followed by thaw, extended culture, and transfer in a subsequent menstrual cycle.
Procedure: Bipronuclear oocyte cryopreservation
Bipronuclear oocyte cryopreservation.

Detailed Description:

Subjects will be randomized to one of two study groups during their cycles of in vitro fertilization (IVF). In one group, the subjects will have all of their embryos cryopreserved at the blastocyst stage, followed by thaw and transfer in a subsequent cycle. In the other group, subjects will have all of their embryos cryopreserved at the bipronuclear oocyte stage, followed by thaw, extended culture, and transfer in a subsequent cycle.

  Eligibility

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

Inclusion Criteria:

  1. Female patient seeking autologous in vitro fertilization (IVF) treatment.
  2. Cycle day 3 serum concentration of follicle stimulating hormone (FSH) less than 10.0 IU/l.
  3. Baseline total antral follicle count observed on ultrasound with at least eight antral follicles.
  4. 18 to 40 years of age.
  5. Ability to read and understand English.

Exclusion Criteria:

  1. Embryo biopsy (a.k.a. pre-implantation genetic diagnosis (PGD)).
  2. Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
  3. No minors will be enrolled in this study.
  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: NCT01247987

Contacts
Contact: Bruce Shapiro, M.D., Ph.D. (702) 254-1777

Locations
United States, Nevada
Fertility Center of Las Vegas Not yet recruiting
Las Vegas, Nevada, United States, 89117
Contact: Bruce Shapiro, M.D., Ph.D.    702-254-1777      
Fertility Center of Las Vegas Recruiting
Las Vegas, Nevada, United States, 89117
Contact: Arlyn Garcia, RN    702-254-1777      
Sponsors and Collaborators
Bruce Shapiro M.D.
  More Information

No publications provided

Responsible Party: Bruce Shapiro M.D., Medica Director, Fertility Center of Las Vegas
ClinicalTrials.gov Identifier: NCT01247987     History of Changes
Other Study ID Numbers: SAIRB 10-0018
Study First Received: November 23, 2010
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Fertility Center of Las Vegas:
IVF, assisted reproduction, embryo transfer

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

ClinicalTrials.gov processed this record on September 14, 2014