InfertilityNCT01506089
Optimizing the Temperature for Embryo Culture in In Vitro Fertilization
A study testing 36 degrees Celsius in people with Infertility, run by Reproductive Medicine Associates of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- 36 degrees Celsius
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Reproductive Medicine Associates of Pennsylvannia
Allentown, Pennsylvania, 18104
Reproductive Medicine Associates of New Jersey
Morristown, New Jersey, 07960
About this study
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.
Read more
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.
- Conditions
- Infertility
- Being tested
- 36 degrees Celsius
- Keywords
- IVF, infertility, PGD, embryo, temperature, incubator, CCS, culture, incubator-36 degrees Celsius, incubator-37 degrees Celsius
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
36 degrees CelsiusOther
Also called IVF, PGD, embryos, culture, CCS, infertility
Embryos in this group will be cultured in incubators set to 36 degrees Celsius.
| Study group | Role | What they receive |
|---|---|---|
| 36 degree group | Experimental | 36 degrees Celsius for the incubators is the experimental condition in this study. Receives: Other: 36 degrees Celsius |
| 37 degree group | No intervention | 37 degrees Celsius is the standard incubator temperature for the culture of embryos. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: approximately 1 week
Secondary outcomes (6)
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)
Measured: approximately 2 days
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).
Measured: approximately 1 week
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.
Measured: approximately 1 week
Implantation Rate
Proportion of transferred embryos resulting in a clinically documented pregnancy will be documented for each group (36 degree and 37 degree group).
Measured: approximately 2 weeks
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).
Measured: approximately 1 month
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).
Measured: approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard T Scott, MD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506089
- Sponsor's protocol ID
- RMA-2011-02
- Status last verified
- Mar 2015
- First submitted
- 3 Jan 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hong KH, Lee H, Forman EJ, Upham KM, Scott RT Jr. Examining the temperature of embryo culture in in vitro fertilization: a randomized controlled trial comparing traditional core temperature (37 degrees C) to a more physiologic, cooler temperature (36 degrees C). Fertil Steril. 2014 Sep;102(3):767-73. doi: 10.1016/j.fertnstert.2014.06.009. Epub 2014 Jul 17.
PubMed 25044079
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Temperature for Embryo Culture in In Vitro Fertilization: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01506089
- Acronym / sponsor ID
- RMA-2011-02
- Conditions
- Infertility
- Keywords
- IVF, infertility, PGD, embryo, temperature, incubator, CCS, culture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 36 degree group | Experimental | Other: 36 degrees Celsius36 degrees Celsius for the incubators is the experimental condition in this study. |
| 37 degree group | No intervention | –37 degrees Celsius is the standard incubator temperature for the culture of embryos. |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 36 degrees CelsiusAlso: IVF, PGD, embryos, culture, CCS, infertilityEmbryos in this group will be cultured in incubators set to 36 degrees Celsius. | Other | 36 degree group |
Primary outcome
Useable Blastocyst Formation Rate
Time frame: approximately 1 week
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).
6 secondary outcomes
Fertilization rate
Time frame: approximately 2 days
Cleavage Rate
Time frame: approximately 1 week
Blastocyst Formation Rate
Time frame: approximately 1 week
Implantation Rate
Time frame: approximately 2 weeks
Aneuploidy Rate
Time frame: approximately 1 month
Mosaicism Rate
Time frame: approximately 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Derived from this study: PubMed 25044079Hong KH, Lee H, Forman EJ, Upham KM, Scott RT Jr. Examining the temperature of embryo culture in in vitro fertilization: a randomized controlled trial comparing traditional core temperature (37 degrees C) to a more physiologic, cooler temperature (36 degrees C). Fertil Steril. 2014 Sep;102(3):767-73. doi: 10.1016/j.fertnstert.2014.06.009. Epub 2014 Jul 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard T Scott, MD principal investigator
Reproductive Medicine Associates of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 36 degrees Celsius in people with Infertility, run by Reproductive Medicine Associates of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Useable Blastocyst Formation Rate (time frame: approximately 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01506089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.