InfertilityNCT00963625
Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients
A study testing Embryo cryopreservation and Fresh blastocyst transfer in people with Infertility, run by Fertility Center of Las Vegas at 1 site in United States.
Trial summary
This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Embryo cryopreservation and Fresh blastocyst transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2010
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patient 18 to 40 years of age seeking their first IVF treatment.
- Cycle day 3 FSH less than 10.0 IU/l.
- 8 to 15 antral follicles observed on ultrasound.
Who cannot join
- Failure to follow the protocol.
- Embryo biopsy.
- Any prior IVF cycle(s).
Trial locations and contacts
1 site in 1 country.
United States1 site
Fertility Center of Las Vegas
Las Vegas, Nevada, 89117
About this study
This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders.
Read the detailed description
The purpose of this study is to determine if blastocyst transfers in cycles of post-thaw extended culture (PTEC) have different efficacy than transfers of fresh blastocysts in patients with expected normal response to ovarian stimulation.
Multiple studies have found altered endometrial histology and gene expression following controlled ovarian stimulation.
PTEC cycles require cryopreservation of the entire 2pn oocyte cohort in the prior cycle. Once thawed, the embryos are cultured to the blastocyst stage before transfer.
In typical cycles using frozen-thawed embryos, many thawed embryos that appear to survive do not actually resume and continue development. PTEC ensures the transfer of embryos that resumed development and continued developing at least to the blastocyst stage (4-5 days post-thaw).
The viability of a blastocyst in a PTEC cycle has been shown to be on par with that of a fresh blastocyst. Therefore, comparing outcomes of blastocyst transfers in PTEC cycles with that in fresh autologous cycles allows the potential endometrial impact of controlled ovarian stimulation to be assessed.
- Conditions
- Infertility
- Being tested
- Embryo cryopreservation, Fresh blastocyst transfer
- Keywords
- Blastocyst transfer, endometrial receptivity, IVF, in vitro fertilization, embryo cryopreservation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embryo cryopreservationProcedure or surgery
Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.
Fresh blastocyst transferProcedure or surgery
Fresh blastocyst transfer following cycle of controlled ovarian stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Blastocyst transfer in PTEC cycle | Experimental | Transfer of two blastocysts derived from thawed bipronuclear oocytes that were subject to post-thaw extended culture (PTEC). Receives: Procedure: Embryo cryopreservation |
| Fresh blastocyst transfer. | Active comparator | Transfer of two fresh autologous blastocysts following controlled ovarian stimulation. Receives: Procedure: Fresh blastocyst transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)
Measured: 7 weeks gestation
Secondary outcomes (2)
Ongoing pregnancy at 10 weeks gestation
Measured: 10 weeks gestation
Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)
Measured: 7 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startOct 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fertility Center of Las Vegas
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals
- Investigators
- Bruce Shapiro, M.D., Ph.D., Principal investigator, Fertility Center of Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963625
- Sponsor's protocol ID
- SAIRB 07-0014
- Status last verified
- Oct 2010
- First submitted
- 19 Aug 2009
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.
PubMed 33539543Shapiro BS, Daneshmand ST, Bedient CE, Garner FC. Comparison of birth weights in patients randomly assigned to fresh or frozen-thawed embryo transfer. Fertil Steril. 2016 Aug;106(2):317-21. doi: 10.1016/j.fertnstert.2016.03.049. Epub 2016 Jul 7.
PubMed 27397626Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C, Thomas S. Evidence of impaired endometrial receptivity after ovarian stimulation for in vitro fertilization: a prospective randomized trial comparing fresh and frozen-thawed embryo transfer in normal responders. Fertil Steril. 2011 Aug;96(2):344-8. doi: 10.1016/j.fertnstert.2011.05.050. Epub 2011 Jul 6.
PubMed 21737072
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients
- ClinicalTrials.gov ID
- NCT00963625
- Acronym / sponsor ID
- SAIRB 07-0014
- Conditions
- Infertility
- Keywords
- Blastocyst transfer, endometrial receptivity, IVF, in vitro fertilization, embryo cryopreservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fertility Center of Las VegasIndustry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Oct 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 21 Aug 2009 (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.
This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders.
Detailed description
The purpose of this study is to determine if blastocyst transfers in cycles of post-thaw extended culture (PTEC) have different efficacy than transfers of fresh blastocysts in patients with expected normal response to ovarian stimulation.
Multiple studies have found altered endometrial histology and gene expression following controlled ovarian stimulation.
PTEC cycles require cryopreservation of the entire 2pn oocyte cohort in the prior cycle. Once thawed, the embryos are cultured to the blastocyst stage before transfer.
In typical cycles using frozen-thawed embryos, many thawed embryos that appear to survive do not actually resume and continue development. PTEC ensures the transfer of embryos that resumed development and continued developing at least to the blastocyst stage (4-5 days post-thaw).
The viability of a blastocyst in a PTEC cycle has been shown to be on par with that of a fresh blastocyst. Therefore, comparing outcomes of blastocyst transfers in PTEC cycles with that in fresh autologous cycles allows the potential endometrial impact of controlled ovarian stimulation to be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blastocyst transfer in PTEC cycle | Experimental | Procedure: Embryo cryopreservationTransfer of two blastocysts derived from thawed bipronuclear oocytes that were subject to post-thaw extended culture (PTEC). |
| Fresh blastocyst transfer. | Active comparator | Procedure: Fresh blastocyst transferTransfer of two fresh autologous blastocysts following controlled ovarian stimulation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patient 18 to 40 years of age seeking their first IVF treatment.
- Cycle day 3 FSH less than 10.0 IU/l.
- 8 to 15 antral follicles observed on ultrasound.
Key exclusion criteria (3 listed)
- Failure to follow the protocol.
- Embryo biopsy.
- Any prior IVF cycle(s).
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 |
|---|---|---|
| Embryo cryopreservationCohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus. | Procedure or surgery | Blastocyst transfer in PTEC cycle |
| Fresh blastocyst transferFresh blastocyst transfer following cycle of controlled ovarian stimulation. | Procedure or surgery | Fresh blastocyst transfer. |
Primary outcome
Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)
Time frame: 7 weeks gestation
2 secondary outcomes
Ongoing pregnancy at 10 weeks gestation
Time frame: 10 weeks gestation
Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)
Time frame: 7 weeks gestation
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 13 Oct 2010.
- Derived from this study: PubMed 33539543Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.
- Derived from this study: PubMed 27397626Shapiro BS, Daneshmand ST, Bedient CE, Garner FC. Comparison of birth weights in patients randomly assigned to fresh or frozen-thawed embryo transfer. Fertil Steril. 2016 Aug;106(2):317-21. doi: 10.1016/j.fertnstert.2016.03.049. Epub 2016 Jul 7.
- Derived from this study: PubMed 21737072Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C, Thomas S. Evidence of impaired endometrial receptivity after ovarian stimulation for in vitro fertilization: a prospective randomized trial comparing fresh and frozen-thawed embryo transfer in normal responders. Fertil Steril. 2011 Aug;96(2):344-8. doi: 10.1016/j.fertnstert.2011.05.050. Epub 2011 Jul 6.
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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.
Bruce Shapiro, M.D., Ph.D. principal investigator
Fertility Center of Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embryo cryopreservation and Fresh blastocyst transfer in people with Infertility, run by Fertility Center of Las Vegas at 1 site 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 3 inclusion and 3 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 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (time frame: 7 weeks gestation). 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 NCT00963625, which also lists 3 linked publications.
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 13 Oct 2010.