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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247987
• Other study ID #: SAIRB 10-0018
• Status: Completed
• Phase: N/A
• First received: November 23, 2010
• Last updated: April 30, 2015
• Start date: December 2010
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Fertility Center of Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Blastocyst cryopreservation
Embryos cryopreserved at the blastocyst stage
• Bipronuclear oocyte cryopreservation
Bipronuclear oocyte cryopreservation.

Locations

Country	Name	City	State
United States	Fertility Center of Las Vegas	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Bruce Shapiro M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	Ultrasonically confirmed fetal heart motion at 10 weeks gestation	10 weeks gestation	No