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NCT01506089 · ClinicalTrials.gov registry record · NA
Optimizing the Temperature for Embryo Culture in In Vitro Fertilization
A NA study, sponsored by Reproductive Medicine Associates of New Jersey.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
NCT01506089 is a NA study that has completed, run by Reproductive Medicine Associates of New Jersey. The registered enrollment target is 55 participants.
The verdict
NCT01506089, a NA study, has completed, sponsored by Reproductive Medicine Associates of New Jersey.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
Study Summary
Many human and animal studies over the past 40 years have revealed that ovaries and Fallopian tubes have a lower temperature than core body temperature, especially around the time of ovulation and early embryo development. Whether average core body temperature, 37 degrees Celsius, is ideal temperature for culture has not been prospectively evaluated. The purpose of this study is to determine whether lowering the incubator temperature by 1 degree Celsius will result in meaningful improvements in embryo development and pregnancy rates. Patients participating in this study will undergo routine in vitro fertilization (IVF) stimulation. Following egg retrieval, patients with at least 8 mature eggs will have those eggs divided randomly into two groups. Both groups will then under ICSI (intra-cytoplasmic sperm injection) to fertilize the eggs. The groups will randomly be assigned to control or study condition. The control condition group will be cultured at 37 degrees Celsius, the current standard of care. The study group will be cultured at 36 degrees Celsius. All other culture conditions will be kept identical and embryos will be assessed on day 3 and day 5 of development. On day 5, all well-developed blastocysts will undergo biopsy for Comprehensive Chromosomal Screening (CCS), which will evaluate the chromosomal normalcy of the embryo . Patients will undergo transfer on the morning of day 6 and the highest quality, chromosomally normal embryo from each group (the 36 degree cultured embryos and the 37 degree cultured embryos) will be transferred. If only 1 embryo is available for transfer, the patient will have a single embryo transfer. All embryos available for cryopreservation will undergo biopsy for CCS before being frozen. Some arrested embryos from each temperature group will also undergo genetic analysis to evaluate chromosomal normalcy or mosaicism. The female patient will undergo a blood draw at 9 weeks gestation and buccal swabs will be obtained from the in
Interventions
- OTHER 36 degrees Celsius
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01506089
The ClinicalTrials.gov registry entry for NCT01506089 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Reproductive Medicine Associates of New Jersey, which has 51 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 36 degrees Celsius is the first listed.
NCT01506089 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01506089 about?
NCT01506089 is a clinical study titled "Optimizing the Temperature for Embryo Culture in In Vitro Fertilization". Many human and animal studies over the past 40 years have revealed that ovaries and Fallopian tubes have a lower temperature than core body temperature, especially around the time of ovulation and early embryo development. Whether average core body temperature, 37 degrees Celsius, is ideal temperatu...
What is the current status of trial NCT01506089?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2012-01. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01506089?
The interventions under investigation include: 36 degrees Celsius (OTHER).
Who is sponsoring clinical trial NCT01506089?
This trial is sponsored by Reproductive Medicine Associates of New Jersey, which has 51 total clinical trials registered on ClinicalTrials.gov.
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