Recurrent Implantation Failure (RIF)RIFNCT02681367
Management of Recurrent Implantation Failure
A study testing Freeze all policy in people with Recurrent Implantation Failure (RIF), run by TopLab Company for ART Laboratories Consultation and Training.
Trial summary
This is the first study to investigate, whether pregnancy and implantation rates would improve in patients with recurrent implantation failure (RIF), if all embryos were to be frozen and transferred in a consecutive natural cycle. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Recurrent Implantation Failure (RIF)
- What is being tested?
- Freeze all policy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Jan 2016
- 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 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- gonadotropin-releasing hormone agonist and recombinant follicle-stimulating hormone (FSH) in a long protocol cycles;
- female partners were under age of 40 years;
- all the patients had a history of recurrent implantation failure i.e: failed to achieve a clinical pregnancy after at least three fresh ICSI cycles where at least 8 good embryos were transferred;
- their embryos were pushed to Day 5 resulting in blastocysts, and undergo embryo transfer day 5 or vitrification on day 5;
- endometrial thickness ≥ 7 mm;
- selected embryos for embryo transfer were blastocysts. -
Who cannot join
- Couples with testicular or epididymal sperm were excluded.
- -
About this study
Official title: The First Study to Compare the Effect of Freeze All Policy Versus Fresh Embryo Transfer After ICSI in Patients With Recurrent Implantation Failure
This is the first study to investigate, whether pregnancy and implantation rates would improve in patients with recurrent implantation failure (RIF), if all embryos were to be frozen and transferred in a consecutive natural cycle.
Read the detailed description
There is growing evidence that elective frozen-thawed embryo transfer in a non-stimulated cycle (freeze-all policy) would eliminate the risk of controlled ovarian stimulation and resulting in better endometrial receptivity and lower uterine contractility as compared with fresh intracytoplasmic sperm injection (ICSI) cycles.
RIF refers to women who fail to achieve a clinical pregnancy, in a minimum of three embryo transfer cycles with at least four good-quality embryos were transferred in a woman < 40 years. It affects approximately 10% of ICSI cases. Many management protocols aimed to enhance ICSI outcome in cases of RIF, however, none of them examined the effect of freeze all policy in this category of patients.
- Conditions
- Recurrent Implantation Failure (RIF)
- Being tested
- Freeze all policy
- Keywords
- Recurrent implantation failure, Freeze all policy, endometrial receptivity, implantation, clinical outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze all policyOther
Also called Frozen-thawed embryo transfer
Cryopreservation of human blastocysts for freeze all group has been employed using vitrification. The blastocysts were transferred after thawing in a frozen-thawed cycle.
| Study group | Role | What they receive |
|---|---|---|
| fresh embryo transfer | No intervention | Patient with RIF underwent ICSI cycle followed by Day 5 fresh embryo transfer. |
| Freeze all | Experimental | Patient with RIF. All of them underwent ICSI cycle, all their embryos were cryopreserved at Day 5 and transferred in a consecutive natural cycle. Receives: Other: Freeze all policy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Clinical pregnancy was identified by fetal cardiac activity on ultrasound examination 4 weeks after embryo transfer.
Measured: 4 weeks post embryo transfer
Secondary outcomes (2)
Ongoing pregnancy rate
Ongoing pregnancy rate was defined as the number of pregnancies with visible fetal heart motion over the number of transferred embryos at 10 weeks' gestation.
Measured: 10 weeks post embryo transfer
Implantation rate
Implantation rate was defined as the number of intrauterine gestational sacs over the total number of embryos transferred.
Measured: 6 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startFeb 2012
- Primary completionJan 2016
- Study completionJan 2016
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 Recurrent Implantation Failure (RIF)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- TopLab Company for ART Laboratories Consultation and Training
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Magdi, TopLab Company for ART Laboratories Consultation and Training
- Investigators
- Yasmin Magdi, M.Sc, Principal investigator, Research and development department director at TopLab Company for ART laboratories consultations and training
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681367
- Sponsor's protocol ID
- #001008
- Acronym
- RIF
- Status last verified
- Feb 2016
- First submitted
- 8 Feb 2016
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Timeva T, Shterev A, Kyurkchiev S. Recurrent implantation failure: the role of the endometrium. J Reprod Infertil. 2014 Oct;15(4):173-83.
PubMed 25473625Roque M. Freeze-all policy: is it time for that? J Assist Reprod Genet. 2015 Feb;32(2):171-6. doi: 10.1007/s10815-014-0391-0. Epub 2014 Nov 27.
PubMed 25428436Simon A, Laufer N. Assessment and treatment of repeated implantation failure (RIF). J Assist Reprod Genet. 2012 Nov;29(11):1227-39. doi: 10.1007/s10815-012-9861-4. Epub 2012 Sep 14.
PubMed 22976427
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Study to Compare the Effect of Freeze All Policy Versus Fresh Embryo Transfer After ICSI in Patients With Recurrent Implantation Failure
- ClinicalTrials.gov ID
- NCT02681367
- Acronym / sponsor ID
- RIF / #001008
- Conditions
- Recurrent Implantation Failure (RIF)
- Keywords
- Recurrent implantation failure, Freeze all policy, endometrial receptivity, implantation, clinical outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- TopLab Company for ART Laboratories Consultation and TrainingUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Feb 2016 (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 is the first study to investigate, whether pregnancy and implantation rates would improve in patients with recurrent implantation failure (RIF), if all embryos were to be frozen and transferred in a consecutive natural cycle.
Detailed description
There is growing evidence that elective frozen-thawed embryo transfer in a non-stimulated cycle (freeze-all policy) would eliminate the risk of controlled ovarian stimulation and resulting in better endometrial receptivity and lower uterine contractility as compared with fresh intracytoplasmic sperm injection (ICSI) cycles.
RIF refers to women who fail to achieve a clinical pregnancy, in a minimum of three embryo transfer cycles with at least four good-quality embryos were transferred in a woman < 40 years. It affects approximately 10% of ICSI cases. Many management protocols aimed to enhance ICSI outcome in cases of RIF, however, none of them examined the effect of freeze all policy in this category of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fresh embryo transfer | No intervention | –Patient with RIF underwent ICSI cycle followed by Day 5 fresh embryo transfer. |
| Freeze all | Experimental | Other: Freeze all policyPatient with RIF. All of them underwent ICSI cycle, all their embryos were cryopreserved at Day 5 and transferred in a consecutive natural cycle. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- gonadotropin-releasing hormone agonist and recombinant follicle-stimulating hormone (FSH) in a long protocol cycles;
- female partners were under age of 40 years;
- all the patients had a history of recurrent implantation failure i.e: failed to achieve a clinical pregnancy after at least three fresh ICSI cycles where at least 8 good embryos were transferred;
- their embryos were pushed to Day 5 resulting in blastocysts, and undergo embryo transfer day 5 or vitrification on day 5;
- endometrial thickness ≥ 7 mm;
Key exclusion criteria (2 listed)
- Couples with testicular or epididymal sperm were excluded.
- -
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 |
|---|---|---|
| Freeze all policyAlso: Frozen-thawed embryo transferCryopreservation of human blastocysts for freeze all group has been employed using vitrification. The blastocysts were transferred after thawing in a frozen-thawed cycle. | Other | Freeze all |
Primary outcome
Clinical pregnancy rate
Time frame: 4 weeks post embryo transfer
Clinical pregnancy was identified by fetal cardiac activity on ultrasound examination 4 weeks after embryo transfer.
2 secondary outcomes
Ongoing pregnancy rate
Time frame: 10 weeks post embryo transfer
Implantation rate
Time frame: 6 weeks after embryo transfer
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 12 Feb 2016.
- Background: PubMed 25473625Timeva T, Shterev A, Kyurkchiev S. Recurrent implantation failure: the role of the endometrium. J Reprod Infertil. 2014 Oct;15(4):173-83.
- Results publication: PubMed 25428436Roque M. Freeze-all policy: is it time for that? J Assist Reprod Genet. 2015 Feb;32(2):171-6. doi: 10.1007/s10815-014-0391-0. Epub 2014 Nov 27.
- Results publication: PubMed 22976427Simon A, Laufer N. Assessment and treatment of repeated implantation failure (RIF). J Assist Reprod Genet. 2012 Nov;29(11):1227-39. doi: 10.1007/s10815-012-9861-4. Epub 2012 Sep 14.
- Individual participant dataSharing planned: Yes
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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.
Yasmin Magdi, M.Sc principal investigator
Research and development department director at TopLab Company for ART laboratories consultations and training
Questions about this trial
What is this clinical trial studying?
A study testing Freeze all policy in people with Recurrent Implantation Failure (RIF), run by TopLab Company for ART Laboratories Consultation and Training.
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 2 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 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 rate (time frame: 4 weeks post embryo transfer). 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 NCT02681367, 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 12 Feb 2016.