Infertility Clinical Trial
Official title:
Comparison of Transfers of Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Fertility Center of Las Vegas | Las Vegas | Nevada |
Lead Sponsor | Collaborator |
---|---|
Bruce Shapiro M.D. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ongoing pregnancy rate | Ultrasonically confirmed fetal heart motion at 10 weeks gestation | 10 weeks gestation | No |
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