InfertilityNCT02746562
Study Comparing Outcomes Between Conventional IVF and a "Freeze-all"-Strategy in Assisted Reproductive Technology
A study testing Freeze all in people with Infertility, run by Anja Bisgaard Pinborg at 2 sites in Denmark.
Trial summary
The purpose of this study is to compare conventional fresh embryo transfer with a "freeze all and transfer later strategy" in assisted reproductive technology in terms of ongoing pregnancy rates, live birth rates as well as perinatal outcomes. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Freeze all
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2016to Sep 2019
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- AMH (Anti-Müllerian hormone) > 6.28 pmol/L (Roche Elecsys assay)
- Female age 18 years to less than 40 years
- 1, 2 or 3 IVF/ICSI cycle with oocyte aspiration
- Regular menstrual cycle between 24 and 35 days
- BMI between 18 and 35
- Two ovaries
- Can and will sign informed consent
Who cannot join
- Women who do not fulfil the inclusion criteria
- Endometriosis stage III to IV
- Ovarian cysts with diameter > 30 mm at day of start of stimulation
- Submucosal fibroids
- Women with severe co-morbidity (IDDM, NIDDM, gastrointestinal, cardiovascular, pulmonary, liver or kidney disease)
- Dysregulation of thyroid disease
Show all 11Show fewer
- Not danish or English speaking women
- Contraindications or allergies to use of Gonadotrophins or GnRH antagonists
- TESA (testicular sperm aspiration)
- OD (oocyte donation)
- Previous inclusion in the study
Trial locations and contacts
2 sites in 1 country.
Sacha Stormlund, MD contact
Anja Bisgaard Pinborg, MD, DMSc contact
Denmark2 sites, 2 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Sacha Stormlund, MD, sacha.stormlund.01@regionh.dk
- Recruiting
University Hospital Hvidovre
Hvidovre
Sacha Stormlund, MD, sacha.stormlund.01@regionh.dk
Anja Pinborg, MD, DMSc, anja.bisgaard.pinborg@regionh.dk
About this study
Official title: A Multicentre Randomized Controlled Trial of a "Freeze All and Transfer Later" Versus a Conventional "Fresh Embryo Transfer" Strategy for Assisted Reproductive Technology (ART) in Women With a Regular Menstrual Cycle
The purpose of this study is to compare conventional fresh embryo transfer with a "freeze all and transfer later strategy" in assisted reproductive technology in terms of ongoing pregnancy rates, live birth rates as well as perinatal outcomes.
Read the detailed description
The study is a multicentre randomized controlled double-blinded trial with the purpose to investigate if pregnancy- and live birth rates can be improved by a "freeze all and transfer later"-strategy with transfer of the best quality, frozen, thawed embryo in a subsequent natural cycle compared with conventional fresh embryo transfer with transfer of the embryo in the stimulated cycle.
In total 5 clinics in Denmark and Sweden will be participating in the recruitment of patients for the study.
The patients will be screened and randomized computerized on cycle day 2 or 3 and allocated to one of the two study arms:
I: hCG (human chorion gonadotrophin) arm with traditional hCG triggering and fresh blastocyst transfer II: GnRH (gonadotropin-releasing hormone)- agonist triggering arm with blastocyst cryopreservation and subsequent transfer in a subsequent natural cycle.
The randomization will be done after the decision of gonadotrophin (rFSH/hMG) starting dose, and both doctor and patient will be blinded to the randomization until the day of hCG/agonist trigger. Both groups will be stimulated in a short GnRH antagonist protocol. The ovarian stimulation The gonadotrophin stimulation is performed according to the general standards in each of the clinics and can be altered according to the ovarian response with a maximum of 300 IU.
Blood samples are collected at baseline before the first gonadotrophin injection and at day of hCG injection and further blood samples in the luteal phase will be collected for a small subgroup of patients. All blood samples will be kept at the Biobank for the study at Hvidovre Hospital.
Women in both arms will furthermore be requested to fill out a physical discomfort and a quality of life questionnaire at two different visits. Additionally the men will be asked to fill out quality of life questionnaires.
Comprehensive sonography will be performed at the start of ovulation with details on each ovary. Ultrasound examination is performed on cycle day 2-3, at stimulation day 6 and thereafter every 2-3 days until ovulation is inducted.
On the day of oocyte retrieval the randomization is unblinded. The oocytes are fertilized by either IVF or ICSI and cultured individually according to the normal procedures in the clinics.
If the patient is allocated to the "Fresh embryo transfer"-group the best quality blastocyst will be transferred on day five after oocyte pick-up, if a blastocyst is developed. Surplus good quality blastocysts are vitrified on day five or six.
For patients in the "Freeze all" group all embryos of good quality are vitrified at the blastocyst stage day 5 in the stimulated cycle according to the criteria for freezing blastocysts in each clinic. The highest quality embryo is selected and marked and will be the first one to be thawed after at least one mentrual cycle that is considered as a wash out period. Embryo transfer is performed 6-7 days after hCG injection in the blastocyst transfer cycle in this group.
A serum beta-hCG test is performed 11 days after blastocyst transfer, and clinical pregnancy is confirmed by transvaginal ultrasound 3 to 4 weeks after a positive serum-hCG test.
A follow-up of all pregnancies will be performed within three months after delivery or termination of pregnancy on predefined information sheets. All pregnancies resulting from blastocysts retrieved and thawed according to this study protocol will be followed from study inclusion and one year onwards.
All data will be collected in a single database and all participants will be anonymized by way of an identificationcode. The biobank will be closed and all samples destroyed after 5 years of the conclusion of the study at the latest.
The study is a superiority study with 424 (212 in each arm) patients required to have an 80 % chance of detecting, as significant at the 5 % level, a decrease in the primary outcome measure from 30 % in the control group to 43 % in the experimental group.
- Conditions
- Infertility
- Being tested
- Freeze all
- Keywords
- Assisted reproduction, In vitro fertilisation, Frozen embryo transfer (FET)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze allProcedure or surgery
Freezing of all blastocyst stage embryos with thawing and transfer in a subsequent natural cycle
| Study group | Role | What they receive |
|---|---|---|
| Freeze all | Experimental | Transfer of a frozen, thawed blastocyst in a subsequent natural menstrual cycle Receives: Procedure: Freeze all |
| Fresh embryo transfer | No intervention | Standard procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rates
Outcome measured per transfer of the first blastocyst, per oocyte pick-up, per start of ovarian stimulation and per randomized patient.
Measured: Two years
Secondary outcomes (16)
Live birth rates
Outcome measured after the first blastocyst transfer calculated per randomized patient, per started ovarian stimulation, per oocyte pick-up and per transfer
Measured: Two years
Cumulative live birth rates
Measured after one stimulated cycle with oocyte retrieval and after use of all frozen blastocysts or after at least 1 year of follow-up
Measured: Two years
Number of cycles with no embryo transfer
Measured: Two years
Time-to-pregnancy
From start of ovarian stimulation to positive hCG
Measured: Two years
Time-to-delivery
Measured: Three years
Preterm birth
Measured: Three years
Low birth weight
Measured: Three years
Small-for-gestational age (SGA)
Measured: Three years
Large-for-gestational age (LGA)
Measured: Three years
Perinatal mortality
Measured: Three years
Preeclampsia
Measured: Three years
Placental rupture
Measured: Three years
Positive hCG 11 days post embryo transfer
Measured: Three years
Miscarriages, biochemical pregnancies, ectopic pregnancies
Measured: Three years
Quality of life for female and partner
Measured: Two years
Cost-effectiveness
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2019
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anja Bisgaard Pinborg
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Herlev Hospital, Holbaek Sygehus, Skane University Hospital, Sahlgrenska University Hospital, Regional Hospital Skive, Dexeus University Hospital Barcelona
- Responsible party
- Sponsor-investigator, Anja Bisgaard Pinborg, Hvidovre University Hospital
- Investigators
- Anja Bisgaard Pinborg, MD, DMSc, Study director, Fertility Clinic, Obstetrical and Gynecological department, Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746562
- Sponsor's protocol ID
- 1600-1116
- Status last verified
- Apr 2019
- First submitted
- 18 Apr 2016
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pilegaard SP, Schmidt L, Stormlund S, Koert E, Bogstad JW, Praetorius L, Nielsen HS, la Cour Freiesleben N, Sopa N, Klajnbard A, Humaidan P, Bergh C, Englund ALM, Lossl K, Pinborg A. Psychosocial wellbeing shortly after allocation to a freeze-all strategy compared with a fresh transfer strategy in women and men: a sub-study of a randomized controlled trial. Hum Reprod. 2023 Nov 2;38(11):2175-2186. doi: 10.1093/humrep/dead188.
PubMed 37742131Alexopoulou E, Stormlund S, Lossl K, Praetorius L, Sopa N, Bogstad JW, Mikkelsen AL, Forman J, la Cour Freiesleben N, Vikkelso Jeppesen J, Bergh C, Al Humaidan PSH, Grondahl ML, Zedeler A, Pinborg AB. Embryo Morphokinetics and Blastocyst Development After GnRH Agonist versus hCG Triggering in Normo-ovulatory Women: a Secondary Analysis of a Multicenter Randomized Controlled Trial. Reprod Sci. 2021 Oct;28(10):2972-2981. doi: 10.1007/s43032-021-00564-9. Epub 2021 Apr 13.
PubMed 33847977Zaat 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 33539543Stormlund S, Sopa N, Zedeler A, Bogstad J, Praetorius L, Nielsen HS, Kitlinski ML, Skouby SO, Mikkelsen AL, Spangmose AL, Jeppesen JV, Khatibi A, la Cour Freiesleben N, Ziebe S, Polyzos NP, Bergh C, Humaidan P, Andersen AN, Lossl K, Pinborg A. Freeze-all versus fresh blastocyst transfer strategy during in vitro fertilisation in women with regular menstrual cycles: multicentre randomised controlled trial. BMJ. 2020 Aug 5;370:m2519. doi: 10.1136/bmj.m2519.
PubMed 32759285Stormlund S, Lossl K, Zedeler A, Bogstad J, Praetorius L, Nielsen HS, Bungum M, Skouby SO, Mikkelsen AL, Andersen AN, Bergh C, Humaidan P, Pinborg A. Comparison of a 'freeze-all' strategy including GnRH agonist trigger versus a 'fresh transfer' strategy including hCG trigger in assisted reproductive technology (ART): a study protocol for a randomised controlled trial. BMJ Open. 2017 Jul 31;7(7):e016106. doi: 10.1136/bmjopen-2017-016106.
PubMed 28760794
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomized Controlled Trial of a "Freeze All and Transfer Later" Versus a Conventional "Fresh Embryo Transfer" Strategy for Assisted Reproductive Technology (ART) in Women With a Regular Menstrual Cycle
- ClinicalTrials.gov ID
- NCT02746562
- Acronym / sponsor ID
- 1600-1116
- Conditions
- Infertility
- Keywords
- Assisted reproduction, In vitro fertilisation, Frozen embryo transfer (FET)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- Anja Bisgaard PinborgUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Herlev Hospital, Holbaek Sygehus, Skane University Hospital, Sahlgrenska University Hospital, Regional Hospital Skive, Dexeus University Hospital Barcelona
- Study start
- May 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Sep 2019 (estimated)
- First posted
- 21 Apr 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.
The purpose of this study is to compare conventional fresh embryo transfer with a "freeze all and transfer later strategy" in assisted reproductive technology in terms of ongoing pregnancy rates, live birth rates as well as perinatal outcomes.
Detailed description
The study is a multicentre randomized controlled double-blinded trial with the purpose to investigate if pregnancy- and live birth rates can be improved by a "freeze all and transfer later"-strategy with transfer of the best quality, frozen, thawed embryo in a subsequent natural cycle compared with conventional fresh embryo transfer with transfer of the embryo in the stimulated cycle.
In total 5 clinics in Denmark and Sweden will be participating in the recruitment of patients for the study.
The patients will be screened and randomized computerized on cycle day 2 or 3 and allocated to one of the two study arms:
I: hCG (human chorion gonadotrophin) arm with traditional hCG triggering and fresh blastocyst transfer II: GnRH (gonadotropin-releasing hormone)- agonist triggering arm with blastocyst cryopreservation and subsequent transfer in a subsequent natural cycle.
The randomization will be done after the decision of gonadotrophin (rFSH/hMG) starting dose, and both doctor and patient will be blinded to the randomization until the day of hCG/agonist trigger. Both groups will be stimulated in a short GnRH antagonist protocol. The ovarian stimulation The gonadotrophin stimulation is performed according to the general standards in each of the clinics and can be altered according to the ovarian response with a maximum of 300 IU.
Blood samples are collected at baseline before the first gonadotrophin injection and at day of hCG injection and further blood samples in the luteal phase will be collected for a small subgroup of patients. All blood samples will be kept at the Biobank for the study at Hvidovre Hospital.
Women in both arms will furthermore be requested to fill out a physical discomfort and a quality of life questionnaire at two different visits. Additionally the men will be asked to fill out quality of life questionnaires.
Comprehensive sonography will be performed at the start of ovulation with details on each ovary. Ultrasound examination is performed on cycle day 2-3, at stimulation day 6 and thereafter every 2-3 days until ovulation is inducted.
On the day of oocyte retrieval the randomization is unblinded. The oocytes are fertilized by either IVF or ICSI and cultured individually according to the normal procedures in the clinics.
If the patient is allocated to the "Fresh embryo transfer"-group the best quality blastocyst will be transferred on day five after oocyte pick-up, if a blastocyst is developed. Surplus good quality blastocysts are vitrified on day five or six.
For patients in the "Freeze all" group all embryos of good quality are vitrified at the blastocyst stage day 5 in the stimulated cycle according to the criteria for freezing blastocysts in each clinic. The highest quality embryo is selected and marked and will be the first one to be thawed after at least one mentrual cycle that is considered as a wash out period. Embryo transfer is performed 6-7 days after hCG injection in the blastocyst transfer cycle in this group.
A serum beta-hCG test is performed 11 days after blastocyst transfer, and clinical pregnancy is confirmed by transvaginal ultrasound 3 to 4 weeks after a positive serum-hCG test.
A follow-up of all pregnancies will be performed within three months after delivery or termination of pregnancy on predefined information sheets. All pregnancies resulting from blastocysts retrieved and thawed according to this study protocol will be followed from study inclusion and one year onwards.
All data will be collected in a single database and all participants will be anonymized by way of an identificationcode. The biobank will be closed and all samples destroyed after 5 years of the conclusion of the study at the latest.
The study is a superiority study with 424 (212 in each arm) patients required to have an 80 % chance of detecting, as significant at the 5 % level, a decrease in the primary outcome measure from 30 % in the control group to 43 % in the experimental group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freeze all | Experimental | Procedure: Freeze allTransfer of a frozen, thawed blastocyst in a subsequent natural menstrual cycle |
| Fresh embryo transfer | No intervention | –Standard procedure |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- AMH (Anti-Müllerian hormone) > 6.28 pmol/L (Roche Elecsys assay)
- Female age 18 years to less than 40 years
- 1, 2 or 3 IVF/ICSI cycle with oocyte aspiration
- Regular menstrual cycle between 24 and 35 days
- BMI between 18 and 35
Key exclusion criteria (11 listed)
- Women who do not fulfil the inclusion criteria
- Endometriosis stage III to IV
- Ovarian cysts with diameter > 30 mm at day of start of stimulation
- Submucosal fibroids
- Women with severe co-morbidity (IDDM, NIDDM, gastrointestinal, cardiovascular, pulmonary, liver or kidney disease)
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 allFreezing of all blastocyst stage embryos with thawing and transfer in a subsequent natural cycle | Procedure or surgery | Freeze all |
Primary outcome
Ongoing pregnancy rates
Time frame: Two years
Outcome measured per transfer of the first blastocyst, per oocyte pick-up, per start of ovarian stimulation and per randomized patient.
16 secondary outcomes
Live birth rates
Time frame: Two years
Cumulative live birth rates
Time frame: Two years
Number of cycles with no embryo transfer
Time frame: Two years
Time-to-pregnancy
Time frame: Two years
Time-to-delivery
Time frame: Three years
Preterm birth
Time frame: Three years
Low birth weight
Time frame: Three years
Small-for-gestational age (SGA)
Time frame: Three years
Large-for-gestational age (LGA)
Time frame: Three years
Perinatal mortality
Time frame: Three years
Preeclampsia
Time frame: Three years
Placental rupture
Time frame: Three years
Positive hCG 11 days post embryo transfer
Time frame: Three years
Miscarriages, biochemical pregnancies, ectopic pregnancies
Time frame: Three years
Quality of life for female and partner
Time frame: Two years
Cost-effectiveness
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Derived from this study: PubMed 37742131Pilegaard SP, Schmidt L, Stormlund S, Koert E, Bogstad JW, Praetorius L, Nielsen HS, la Cour Freiesleben N, Sopa N, Klajnbard A, Humaidan P, Bergh C, Englund ALM, Lossl K, Pinborg A. Psychosocial wellbeing shortly after allocation to a freeze-all strategy compared with a fresh transfer strategy in women and men: a sub-study of a randomized controlled trial. Hum Reprod. 2023 Nov 2;38(11):2175-2186. doi: 10.1093/humrep/dead188.
- Derived from this study: PubMed 33847977Alexopoulou E, Stormlund S, Lossl K, Praetorius L, Sopa N, Bogstad JW, Mikkelsen AL, Forman J, la Cour Freiesleben N, Vikkelso Jeppesen J, Bergh C, Al Humaidan PSH, Grondahl ML, Zedeler A, Pinborg AB. Embryo Morphokinetics and Blastocyst Development After GnRH Agonist versus hCG Triggering in Normo-ovulatory Women: a Secondary Analysis of a Multicenter Randomized Controlled Trial. Reprod Sci. 2021 Oct;28(10):2972-2981. doi: 10.1007/s43032-021-00564-9. Epub 2021 Apr 13.
- 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 32759285Stormlund S, Sopa N, Zedeler A, Bogstad J, Praetorius L, Nielsen HS, Kitlinski ML, Skouby SO, Mikkelsen AL, Spangmose AL, Jeppesen JV, Khatibi A, la Cour Freiesleben N, Ziebe S, Polyzos NP, Bergh C, Humaidan P, Andersen AN, Lossl K, Pinborg A. Freeze-all versus fresh blastocyst transfer strategy during in vitro fertilisation in women with regular menstrual cycles: multicentre randomised controlled trial. BMJ. 2020 Aug 5;370:m2519. doi: 10.1136/bmj.m2519.
- Derived from this study: PubMed 28760794Stormlund S, Lossl K, Zedeler A, Bogstad J, Praetorius L, Nielsen HS, Bungum M, Skouby SO, Mikkelsen AL, Andersen AN, Bergh C, Humaidan P, Pinborg A. Comparison of a 'freeze-all' strategy including GnRH agonist trigger versus a 'fresh transfer' strategy including hCG trigger in assisted reproductive technology (ART): a study protocol for a randomised controlled trial. BMJ Open. 2017 Jul 31;7(7):e016106. doi: 10.1136/bmjopen-2017-016106.
- Individual participant dataSharing planned: No
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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.
Sacha Stormlund, MD contact
Anja Bisgaard Pinborg, MD, DMSc contact
Anja Bisgaard Pinborg, MD, DMSc study director
Fertility Clinic, Obstetrical and Gynecological department, Hvidovre Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze all in people with Infertility, run by Anja Bisgaard Pinborg at 2 sites in Denmark.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 2 Apr 2019. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sacha Stormlund, MD (sacha.stormlund.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rates (time frame: Two years). 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 NCT02746562, which also lists 5 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 2 Apr 2019; AzTrials last refreshed its copy on 29 Oct 2026.