Infertility Clinical Trial
Official title:
Optimizing the Temperature for Embryo Culture in In Vitro Fertilization: A Randomized Controlled Trial
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 infant(s) after birth.
Status | Completed |
Enrollment | 55 |
Est. completion date | July 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 41 Years |
Eligibility |
Inclusion Criteria: - No more than 1 prior failed cycle at RMA NJ facility; up to 2 prior failed cycles at another facility pending investigator review - Female partner between 18 and 41 at onset of IVF cycle - Normal day 3 FSH (< or = 12) in RMA NJ laboratory - Basal antral follicle count of at least 10 - Male partner with greater than 100,000 total motile spermatozoa per ejaculate (donor sperm is ok) - BMI < or = 32 kg/m2 Exclusion Criteria: - Diagnosis of chronic anovulation (cycles occuring typically less often than every 90 days) - Use of testicular aspiration or biopsy procedures to obtain sperm - Unevaluated ovarian mass or diagnosis of surgically-confirmed stage IV endometriosis - Presence of hydrosalpinges that communicate with the uterine cavity - History of endometrial insufficiency - Any contraindication to undergoing IVF or gonadotropin stimulation - Prior poor fertilization rate- less than 50% of mature eggs - Prior poor blastulation rate- less than 10% of 2PNs (day 1 embryos) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Reproductive Medicine Associates of Pennsylvannia | Allentown | Pennsylvania |
United States | Reproductive Medicine Associates of New Jersey | Morristown | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Reproductive Medicine Associates of New Jersey |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Useable Blastocyst Formation Rate | Proportion of mature eggs developing into expanded blastocysts (Gardner grade 3-6) of sufficient quality to transfer or cryopreserve will be documented for each group (36 degree and 37 degree group). | approximately 1 week | No |
Secondary | Fertilization rate | The proportion of mature eggs that underwent ICSI and are normally fertlized (documented as forming 2 pro-nuclei (2PNs)) on the day after egg retrieval will be documented for each group (36 degree and 37 degree groups) | approximately 2 days | No |
Secondary | Cleavage Rate | Proportion of properly fertlized embryo (2PNs on day 1) that undergo further celluar division will be documented for each group (36 degree and 37 degree group). | approximately 1 week | No |
Secondary | Blastocyst Formation Rate | Proportion of mature oocytes that go on to develop into blastocysts in each group (36 degree group and 37 degree group) will be documented. | approximately 1 week | No |
Secondary | Implantation Rate | Proportion of transferred embryos resulting in a clinically documented pregnancy will be documented for each group (36 degree and 37 degree group). | approximately 2 weeks | No |
Secondary | Aneuploidy Rate | Rate of chromosomal abnormalities among the embryos in each group (36 degree and 37 degree groups) as determined by polymerase chain reaction (PCR) based comprehensive chromosome screening (CCS). | approximately 1 month | No |
Secondary | Mosaicism Rate | Proportion of embryos that arrest at the cleavage stage which show evidence of more than one chromosomal lineages (mosaicism) when analyzed my microarray documented in each group (36 degree and 37 degree group). | approximately 1 month | No |
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