InfertilityNCT01247987
Comparison of Transfers of Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes
A study testing Blastocyst cryopreservation and Bipronuclear oocyte cryopreservation in people with Infertility, run by Bruce Shapiro M.D. at 1 site in United States.
Trial summary
The purpose of this study is to determine if cryopreservation at the blastocyst stage followed by embryo thaw and transfer is as effective as cryopreservation of bipronuclear oocytes followed by post-thaw extended culture (PTEC), and blastocyst transfer. 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?
- Blastocyst cryopreservation and Bipronuclear oocyte cryopreservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Apr 2015
- 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 seeking autologous in vitro fertilization (IVF) treatment.
- Cycle day 3 serum concentration of follicle stimulating hormone (FSH) less than 10.0 IU/l.
- Baseline total antral follicle count observed on ultrasound with at least eight antral follicles.
- 18 to 40 years of age.
- Ability to read and understand English.
Who cannot join
- Embryo biopsy (a.k.a. pre-implantation genetic diagnosis (PGD)).
- Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
- No minors will be enrolled in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fertility Center of Las Vegas
Las Vegas, Nevada, 89117
About this study
The purpose of this study is to determine if cryopreservation at the blastocyst stage followed by embryo thaw and transfer is as effective as cryopreservation of bipronuclear oocytes followed by post-thaw extended culture (PTEC), and blastocyst transfer. Effectiveness will be measured by the rate of ongoing pregnancy at 10 weeks gestation.
Read the detailed description
Subjects will be randomized to one of two study groups during their cycles of in vitro fertilization (IVF). In one group, the subjects will have all of their embryos cryopreserved at the blastocyst stage, followed by thaw and transfer in a subsequent cycle. In the other group, subjects will have all of their embryos cryopreserved at the bipronuclear oocyte stage, followed by thaw, extended culture, and transfer in a subsequent cycle.
- Conditions
- Infertility
- Being tested
- Blastocyst cryopreservation, Bipronuclear oocyte cryopreservation
- Keywords
- IVF, assisted reproduction, embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blastocyst cryopreservationProcedure or surgery
Embryos cryopreserved at the blastocyst stage
Bipronuclear oocyte cryopreservationProcedure or surgery
Bipronuclear oocyte cryopreservation.
| Study group | Role | What they receive |
|---|---|---|
| Blastocyst cryopreservation | Active comparator | Subjects randomly assigned to this arm of the study will have all of their embryos cryopreserved at the blastocyst stage, followed by thaw and transfer in a subsequent menstrual cycle. Receives: Procedure: Blastocyst cryopreservation |
| Bipronuclear oocyte cryopreservation | Experimental | Subjects randomly assigned to this arm of the study will have all of their bipronuclear oocytes cryopreserved, followed by thaw, extended culture, and transfer in a subsequent menstrual cycle. Receives: Procedure: Bipronuclear oocyte cryopreservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Ultrasonically confirmed fetal heart motion at 10 weeks gestation
Measured: 10 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2014
- Study completionApr 2015
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruce Shapiro M.D.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Bruce Shapiro M.D., Fertility Center of Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247987
- Sponsor's protocol ID
- SAIRB 10-0018
- Status last verified
- Apr 2015
- First submitted
- 23 Nov 2010
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C. Freeze-all at the blastocyst or bipronuclear stage: a randomized clinical trial. Fertil Steril. 2015 Nov;104(5):1138-44. doi: 10.1016/j.fertnstert.2015.07.1141. Epub 2015 Aug 5.
PubMed 26255088
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transfers of Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes
- ClinicalTrials.gov ID
- NCT01247987
- Acronym / sponsor ID
- SAIRB 10-0018
- Conditions
- Infertility
- Keywords
- IVF, assisted reproduction, embryo transfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Bruce Shapiro M.D.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Nov 2010 (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.
The purpose of this study is to determine if cryopreservation at the blastocyst stage followed by embryo thaw and transfer is as effective as cryopreservation of bipronuclear oocytes followed by post-thaw extended culture (PTEC), and blastocyst transfer. Effectiveness will be measured by the rate of ongoing pregnancy at 10 weeks gestation.
Detailed description
Subjects will be randomized to one of two study groups during their cycles of in vitro fertilization (IVF). In one group, the subjects will have all of their embryos cryopreserved at the blastocyst stage, followed by thaw and transfer in a subsequent cycle. In the other group, subjects will have all of their embryos cryopreserved at the bipronuclear oocyte stage, followed by thaw, extended culture, and transfer in a subsequent cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blastocyst cryopreservation | Active comparator | Procedure: Blastocyst cryopreservationSubjects randomly assigned to this arm of the study will have all of their embryos cryopreserved at the blastocyst stage, followed by thaw and transfer in a subsequent menstrual cycle. |
| Bipronuclear oocyte cryopreservation | Experimental | Procedure: Bipronuclear oocyte cryopreservationSubjects randomly assigned to this arm of the study will have all of their bipronuclear oocytes cryopreserved, followed by thaw, extended culture, and transfer in a subsequent menstrual cycle. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female patient seeking autologous in vitro fertilization (IVF) treatment.
- Cycle day 3 serum concentration of follicle stimulating hormone (FSH) less than 10.0 IU/l.
- Baseline total antral follicle count observed on ultrasound with at least eight antral follicles.
- 18 to 40 years of age.
- Ability to read and understand English.
Key exclusion criteria (3 listed)
- Embryo biopsy (a.k.a. pre-implantation genetic diagnosis (PGD)).
- Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
- No minors will be enrolled in this study.
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 |
|---|---|---|
| Blastocyst cryopreservationEmbryos cryopreserved at the blastocyst stage | Procedure or surgery | Blastocyst cryopreservation |
| Bipronuclear oocyte cryopreservationBipronuclear oocyte cryopreservation. | Procedure or surgery | Bipronuclear oocyte cryopreservation |
Primary outcome
Ongoing pregnancy rate
Time frame: 10 weeks gestation
Ultrasonically confirmed fetal heart motion at 10 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 1 May 2015.
- Derived from this study: PubMed 26255088Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C. Freeze-all at the blastocyst or bipronuclear stage: a randomized clinical trial. Fertil Steril. 2015 Nov;104(5):1138-44. doi: 10.1016/j.fertnstert.2015.07.1141. Epub 2015 Aug 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blastocyst cryopreservation and Bipronuclear oocyte cryopreservation in people with Infertility, run by Bruce Shapiro M.D. 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 5 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 1 May 2015. 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?
Ongoing pregnancy rate (time frame: 10 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 NCT01247987, 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 1 May 2015.