- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00708487
Live Births With Low Oxygen Blastocyst Culture (Oxygen)
A Controlled Randomized Trial Evaluating the Effect of Lowered Incubator Oxygen Tension on Live Births in a Predominantly Blastocyst Transfer Program
Study Overview
Status
Intervention / Treatment
Detailed Description
Purpose: The purpose of this study is to determine if a more physiological oxygen concentration (5%) will improve clinical outcomes when compared with the industry standard of 21%.
Background: For embryos to grow in the incubator, atmospheric gas concentrations should be as close to possible to those seen in the oviduct or uterus. Currently, atmospheric (non-physiological, 21%) oxygen concentrations are used in the incubators to culture the embryos of infertility patients of the Presbyterian ARTS laboratories. Literature suggest that culturing animal embryos in a reduced oxygen environment will significantly improve embryo quality and clinical outcomes. Both 5% and atmospheric oxygen concentrations are routinely used for embryo culture in the human IVF laboratories, however, very few commercial human IVF facilities invest in oxygen control as it is more expensive to maintain and labor intensive to implement. The goal is to use lower oxygen concentrations in the future if clinical improvement justifies the expense and increased labor associated with low oxygen culture.
Project Summary: Study design: The study will be conducted in a prospective, randomized way. Two treatment groups are considered: 1) existing atmospheric oxygen concentration in embryo incubators 2) lower 5% oxygen concentration in embryo culture incubators. To allow for the well-documented decline in pregnancy rates with increased age, patients will be stratified within 4 age groups and 3 physicians within each treatment. The age groups are: donor eggs; <35 years; 35 to 37 years; and 38 to 40 years as determined on the day of egg retrieval.
Endpoints Measured: The endpoints measured will be embryo cryopreservation-biochemical pregnancy-, clinical pregnancy-, ongoing pregnancy-, live birth- and embryo implantation rates.
Number of Patients in the Study: To detect a difference of 10% in pregnancy rates, 150 patients should be included in each treatment group. With the current patient volume, it should take less than one year to complete the study. Differences in implantation rates may be detected earlier (more embryos transferred than patients enrolled). Should significance differences in pregnancy rates become evident before the full number of patients is enrolled, the study may be terminated.
Study Location: The study will be conducted at the ARTS facility of Presbyterian Hospital of Plano.
Criteria for Inclusion of Subjects: All patients undergoing a first IVF cycle or any donor oocyte cycle is eligible to participate in this laboratory comparison. The eggs may be fertilized with conventional IVF methodology or by using intracytoplasmic sperm injection (ICSI). When performing ICSI, ejaculated sperm must be used. Patients using their own eggs must be 40 years of age or younger on the day of egg retrieval. The Presbyterian Hospital ARTS Program performed ~900 egg retrievals in 2000. Of these, ~500 would have met the inclusion criteria of this study.
Criteria for Exclusion of Subjects: To reduce the tremendous patient variability seen in the infertile patient population, only first cycle patients 40 years of age or younger on the day of egg retrieval should participate.
Sources of Research Material: Patients will be enrolled in this study from the regular patient pool presented to the Presbyterian ARTS Program for treatment of infertility. Data will not be collected specifically for research purposes. Data to be used are collected on all ARTS patients, regardless of participation in the study.
Recruitment of Subjects: Subjects for this study will be recruited from the regular patient pool presented to the ARTS Program for the treatment of infertility. Patients that will meet the inclusion criteria of this study can be identified prospectively. Information about the study will be included in the routine, biweekly, group laboratory and nursing orientation sessions.
Potential Risks: Patients consenting to the comparison will allow their embryos to be cultured in either the standard atmospheric oxygen concentration or in a reduced, more physiological oxygen concentration. Atmospheric (21%) oxygen concentrations is the current standard in this program. Both methods are considered industry standard. To our best knowledge and as reported in animal literature, low oxygen culture should do better rather than worse under the conditions proposed for this study. No other culture conditions or culture media compositions/ingredients that will be applied during this comparison is experimental. However, when atmospheric oxygen concentrations and lowered (5%) oxygen concentrations are compared in a controlled, randomized way as suggested in this comparison, the ARTS Program can not guarantee that the pregnancy outcome will be equivalent for both treatment groups. Therefore, by being randomized, a patient may be included in a group with a lower success rate.
Special Precautions: If it should become clear early in the study that either one of the treatments are superior to the other, the study will be discontinued and the best conditions implemented for future patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Plano, Texas, United States, 75093
- Presbyterian Hospital of Palno
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- First IVF cycle or donor oocyte cycle
- IVF or ICSI
- Ejaculated sperm only for ICSI
- <41 years of age
Exclusion Criteria:
One or more failed IVF cycles
- 40 years of age
- Using testicular or epididymal sperm for fertilization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
5% oxygen embryo culture condition
|
Two concentrations of oxygen are currently used to culture the embryos of infertile patients in commercial human IVF programs - 21% and 5%.
|
Active Comparator: 2
21% oxygen embryo culture condition
|
Two concentrations of oxygen are currently used to culture the embryos of infertile patients in commercial human IVF programs - 21% and 5%.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Live birth
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Implantation rate
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marius Meintjes, PhD, Texas Health Resources
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PresbyterianHDallasARTSO2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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