FertilityPhase 4SONTECNCT02834117
Natural Cycle Versus Stimulated Cycle Before Frozen Embryo Transfer
A Phase 4 study testing natural cycle and moderate ovarian stimulation in people with Fertility, run by Dr Massin Nathalie at 1 site in France.
Trial summary
Embryo freezing is a technique used regularly to optimize the pregnancy rate in case of infertility. This method is performed in presence of supernumerary embryo(s) after fresh transfer, or after freeze all embryos in case of medical reasons. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Fertility
- What is being tested?
- natural cycle and moderate ovarian stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Mar 2018
- Phase
- Phase 4
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Affiliation to the general social security regime and benefiting from 100% infertility;
- Regular Cycles 26 to 35 days;
- Support in IVF or ICSI ;
- Existence of at least 2 frozen embryos to J2 or J3;
- Treated for their first or second cycle of TEC.
Who cannot join
- Donor sperm;
- Irregular cycles and / or polycystic ovary syndrome;
- Embryos frozen at J1 or J5 / J6 or double planned transfer or transfer of 3 embryos intended;
- Patients who have had more than 3 transfers or more than 6 embryos replaced without pregnancy or puncture rank> 3;
- uterine malformation existing;
- Presence of a hydrosalpinx.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Number of Visits and the Quality of Life Versus Natural Cycle in Stimulated Cycle Before Frozen Embryo Transfer
Embryo freezing is a technique used regularly to optimize the pregnancy rate in case of infertility. This method is performed in presence of supernumerary embryo(s) after fresh transfer, or after freeze all embryos in case of medical reasons. It is necessary to control that the transfer is performed when the endometrium is receptive, which is essential for embryo implantation and pregnancy. This period is defined as the "implantation window". Endometrial preparation can be achieved by hormone replacement therapy (HRT) or moderate ovarian stimulation (SO). The implantation window can also be assessed by monitoring of a natural cycle (NC). The objectives of this open randomized study is to compare the number of visits (ultrasound and blood tests) induced by the SO or NC as well as the women quality of life in both groups.
Read the detailed description
For infertile couples supported by in vitro fertilization, embryo freezing is a technique used regularly to optimize the pregnancy rate per retrieval of oocytes. This method is performed in case of supernumerary embryo(s) after fresh embryo transfer, or freeze all of the embryonic cohort in case of medical reasons preventing the transfer. The embryo or embryos can then be thawed and transferred (FET) to achieve a live birth. However, it is necessary to first ensure that the transfer is carried out at a time when the endometrium is receptive, which is essential for embryo implantation and pregnancy. This period is defined as the "implantation window". Endometrial preparation can be performed by hormone replacement therapy (HRT) or moderate ovarian stimulation (SO). The implantation window can also be assessed by the monitoring of a natural cycle (NC). The choice of the key moment for the transfer is determined by ovulation and / or the rise of progesterone. To date, no study has demonstrated the superiority of one protocol over another in terms of birth rates. In the investigative center, treatment is usually carried out by daily subcutaneous injections of gonadotrophins followed by ovulation induction. In this context, the implementation of the FET in natural cycle may appear less burdensome for the patient and more physiological. The consideration is additional constraints, NC imposing more frequent monitoring (ultrasound and / or hormone assays) to detect the ovulation peak and less freedom in choosing the date of transfer. The average number of visits with SO is 2.6 per cycle. The aim of this study is to compare the stresses and safety of these two therapeutic proposals to determine the least restrictive for patients.
- Conditions
- Fertility
- Being tested
- natural cycle, moderate ovarian stimulation
- Keywords
- Ovulation Induction, quality of life, Reproductive Physiological Processes, fertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natural cycleOther
Also called natural
Ovulation is not induced by drugs
moderate ovarian stimulationDrug
Also called ovarian stimulation
Ovulation is induced by recombinant follitropin alpha and recombinant choriogonadotropin
| Study group | Role | What they receive |
|---|---|---|
| Natural cycle | Other | Ovulation is not induced by drugs Receives: Other: natural cycle |
| Moderate ovarian stimulation | Experimental | Ovulation is induced by recombinant follitropin alpha and recombinant choriogonadotropin Receives: Drug: moderate ovarian stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of visits
number of visits (for clinical examination, ultrasound and hormonal dosage) required to monitor ovulation in both groups
Measured: From inclusion visit to embryo transfer : up to 90 days
Secondary outcomes (10)
Fertiqol
the score of quality of life related to the couple's infertility, the Fertiqol questionnaire, a questionnaire validated by the European Society of Human Reproduction and Embryology (ESHRE) and taking into account the tolerance to treatment;
Measured: From inclusion visit to embryo transfer : up to 90 days
defrost cancellation rate
the defrost cancellation rate cycle started, whatever the cause: Early ovulation problem of organization, ... excluding "non-transfer" related to embryo lysis thawing
Measured: From inclusion visit to embryo transfer : up to 90 days
transfer on weekends and holidays
the transfer rate on weekends and holidays
Measured: From inclusion visit to embryo transfer : up to 90 days
HCG levels> 100 U / L
the incipient pregnancy rate per transfer defined by a HCG levels> 100 U / L
Measured: From inclusion visit to pregnancy test : up to 100 days
pregnancy
the rate of pregnancy by ultrasound transfer defined by the presence of a cardiac activity
Measured: From pregnancy test to ultrasound at 6 week of gestation : up to 100 days
Birth
The live birth rate per transfer defined by the birth of at least one living child
Measured: From transfer to delivery : up to 9 months
Gestationnal age at delivery
the term of delivery
Measured: From transfer to delivery : up to 9 months
Implantation
the implantation rate defined by the total number of live births to the total number of embryos replaced
Measured: From transfer to delivery : up to 9 months
Miscarriage
the rate of early miscarriage (before 12 SA)
Measured: From pregnancy test to ultrasound at 6 week of gestation : up to 100 days
Cost
the average estimated cost of drug treatment and monitoring (ultrasound and hormone assays).
Measured: From pregnancy test to ultrasound at 6 week of gestation : up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startMay 2015
- Primary completionFeb 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for FertilityStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Massin Nathalie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Massin Nathalie, Centre Hospitalier Intercommunal Creteil
- Investigators
- Nathalie Massin, MD, Principal investigator, CHIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834117
- Sponsor's protocol ID
- SONTEC
- Acronym
- SONTEC
- Status last verified
- Feb 2019
- First submitted
- 3 Sep 2015
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bjuresten K, Landgren BM, Hovatta O, Stavreus-Evers A. Luteal phase progesterone increases live birth rate after frozen embryo transfer. Fertil Steril. 2011 Feb;95(2):534-7. doi: 10.1016/j.fertnstert.2010.05.019. Epub 2010 Jun 26.
PubMed 20579989Boivin J, Takefman J, Braverman A. The fertility quality of life (FertiQoL) tool: development and general psychometric properties. Hum Reprod. 2011 Aug;26(8):2084-91. doi: 10.1093/humrep/der171. Epub 2011 Jun 10.
PubMed 21665875de La Rochebrochard E, Quelen C, Peikrishvili R, Guibert J, Bouyer J. Long-term outcome of parenthood project during in vitro fertilization and after discontinuation of unsuccessful in vitro fertilization. Fertil Steril. 2009 Jul;92(1):149-56. doi: 10.1016/j.fertnstert.2008.05.067. Epub 2008 Aug 15.
PubMed 18706550Eftekhar M, Rahmani E, Pourmasumi S. Evaluation of clinical factors influencing pregnancy rate in frozen embryo transfer. Iran J Reprod Med. 2014 Jul;12(7):513-8.
PubMed 25114675El Bahja D, Hertz P, Schweitzer T, Lestrade F, Ragage JP. [Frozen embryo transfer protocol: does spontaneous cycle give good results?]. Gynecol Obstet Fertil. 2013 Nov;41(11):648-52. doi: 10.1016/j.gyobfe.2011.08.007. Epub 2012 Feb 16. French.
PubMed 22342107Fatemi HM, Kyrou D, Bourgain C, Van den Abbeel E, Griesinger G, Devroey P. Cryopreserved-thawed human embryo transfer: spontaneous natural cycle is superior to human chorionic gonadotropin-induced natural cycle. Fertil Steril. 2010 Nov;94(6):2054-8. doi: 10.1016/j.fertnstert.2009.11.036. Epub 2010 Jan 25.
PubMed 20097333Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2.
PubMed 23820515Haouzi D, Assou S, Mahmoud K, Tondeur S, Reme T, Hedon B, De Vos J, Hamamah S. Gene expression profile of human endometrial receptivity: comparison between natural and stimulated cycles for the same patients. Hum Reprod. 2009 Jun;24(6):1436-45. doi: 10.1093/humrep/dep039. Epub 2009 Feb 26.
PubMed 19246470Nargund G, Wei CC. Successful planned delay of ovulation for one week with indomethacin. J Assist Reprod Genet. 1996 Sep;13(8):683-4. doi: 10.1007/BF02069650. No abstract available.
PubMed 8897131Park SJ, Goldsmith LT, Skurnick JH, Wojtczuk A, Weiss G. Characteristics of the urinary luteinizing hormone surge in young ovulatory women. Fertil Steril. 2007 Sep;88(3):684-90. doi: 10.1016/j.fertnstert.2007.01.045. Epub 2007 Apr 16.
PubMed 17434509Tobler KJ, Zhao Y, Weissman A, Majumdar A, Leong M, Shoham Z. Worldwide survey of IVF practices: trigger, retrieval and embryo transfer techniques. Arch Gynecol Obstet. 2014 Sep;290(3):561-8. doi: 10.1007/s00404-014-3232-6. Epub 2014 Apr 18.
PubMed 24744054Tomas C, Alsbjerg B, Martikainen H, Humaidan P. Pregnancy loss after frozen-embryo transfer--a comparison of three protocols. Fertil Steril. 2012 Nov;98(5):1165-9. doi: 10.1016/j.fertnstert.2012.07.1058. Epub 2012 Jul 27.
PubMed 22840239Troude P, Guibert J, Bouyer J, de La Rochebrochard E; DAIFI Group. Medical factors associated with early IVF discontinuation. Reprod Biomed Online. 2014 Mar;28(3):321-9. doi: 10.1016/j.rbmo.2013.10.018. Epub 2013 Oct 31.
PubMed 24461478Weissman A, Levin D, Ravhon A, Eran H, Golan A, Levran D. What is the preferred method for timing natural cycle frozen-thawed embryo transfer? Reprod Biomed Online. 2009 Jul;19(1):66-71. doi: 10.1016/s1472-6483(10)60048-x.
PubMed 19573293Yu J, Ma Y, Wu Z, Li Y, Tang L, Li Y, Deng B. Endometrial preparation protocol of the frozen-thawed embryo transfer in patients with polycystic ovary syndrome. Arch Gynecol Obstet. 2015 Jan;291(1):201-11. doi: 10.1007/s00404-014-3396-0. Epub 2014 Jul 31.
PubMed 25091221
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Number of Visits and the Quality of Life Versus Natural Cycle in Stimulated Cycle Before Frozen Embryo Transfer
- ClinicalTrials.gov ID
- NCT02834117
- Acronym / sponsor ID
- SONTEC / SONTEC
- Conditions
- Fertility
- Keywords
- Ovulation Induction, quality of life, Reproductive Physiological Processes, fertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Dr Massin NathalieUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 15 Jul 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.
Embryo freezing is a technique used regularly to optimize the pregnancy rate in case of infertility. This method is performed in presence of supernumerary embryo(s) after fresh transfer, or after freeze all embryos in case of medical reasons. It is necessary to control that the transfer is performed when the endometrium is receptive, which is essential for embryo implantation and pregnancy. This period is defined as the "implantation window". Endometrial preparation can be achieved by hormone replacement therapy (HRT) or moderate ovarian stimulation (SO). The implantation window can also be assessed by monitoring of a natural cycle (NC). The objectives of this open randomized study is to compare the number of visits (ultrasound and blood tests) induced by the SO or NC as well as the women quality of life in both groups.
Detailed description
For infertile couples supported by in vitro fertilization, embryo freezing is a technique used regularly to optimize the pregnancy rate per retrieval of oocytes. This method is performed in case of supernumerary embryo(s) after fresh embryo transfer, or freeze all of the embryonic cohort in case of medical reasons preventing the transfer. The embryo or embryos can then be thawed and transferred (FET) to achieve a live birth. However, it is necessary to first ensure that the transfer is carried out at a time when the endometrium is receptive, which is essential for embryo implantation and pregnancy. This period is defined as the "implantation window". Endometrial preparation can be performed by hormone replacement therapy (HRT) or moderate ovarian stimulation (SO). The implantation window can also be assessed by the monitoring of a natural cycle (NC). The choice of the key moment for the transfer is determined by ovulation and / or the rise of progesterone. To date, no study has demonstrated the superiority of one protocol over another in terms of birth rates. In the investigative center, treatment is usually carried out by daily subcutaneous injections of gonadotrophins followed by ovulation induction. In this context, the implementation of the FET in natural cycle may appear less burdensome for the patient and more physiological. The consideration is additional constraints, NC imposing more frequent monitoring (ultrasound and / or hormone assays) to detect the ovulation peak and less freedom in choosing the date of transfer. The average number of visits with SO is 2.6 per cycle. The aim of this study is to compare the stresses and safety of these two therapeutic proposals to determine the least restrictive for patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural cycle | Other | Other: natural cycleOvulation is not induced by drugs |
| Moderate ovarian stimulation | Experimental | Drug: moderate ovarian stimulationOvulation is induced by recombinant follitropin alpha and recombinant choriogonadotropin |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Affiliation to the general social security regime and benefiting from 100% infertility;
- Regular Cycles 26 to 35 days;
- Support in IVF or ICSI ;
- Existence of at least 2 frozen embryos to J2 or J3;
- Treated for their first or second cycle of TEC.
Key exclusion criteria (6 listed)
- Donor sperm;
- Irregular cycles and / or polycystic ovary syndrome;
- Embryos frozen at J1 or J5 / J6 or double planned transfer or transfer of 3 embryos intended;
- Patients who have had more than 3 transfers or more than 6 embryos replaced without pregnancy or puncture rank> 3;
- uterine malformation existing;
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 |
|---|---|---|
| natural cycleAlso: naturalOvulation is not induced by drugs | Other | Natural cycle |
| moderate ovarian stimulationAlso: ovarian stimulationOvulation is induced by recombinant follitropin alpha and recombinant choriogonadotropin | Drug | Moderate ovarian stimulation |
Primary outcome
Number of visits
Time frame: From inclusion visit to embryo transfer : up to 90 days
number of visits (for clinical examination, ultrasound and hormonal dosage) required to monitor ovulation in both groups
10 secondary outcomes
Fertiqol
Time frame: From inclusion visit to embryo transfer : up to 90 days
defrost cancellation rate
Time frame: From inclusion visit to embryo transfer : up to 90 days
transfer on weekends and holidays
Time frame: From inclusion visit to embryo transfer : up to 90 days
HCG levels> 100 U / L
Time frame: From inclusion visit to pregnancy test : up to 100 days
pregnancy
Time frame: From pregnancy test to ultrasound at 6 week of gestation : up to 100 days
Birth
Time frame: From transfer to delivery : up to 9 months
Gestationnal age at delivery
Time frame: From transfer to delivery : up to 9 months
Implantation
Time frame: From transfer to delivery : up to 9 months
Miscarriage
Time frame: From pregnancy test to ultrasound at 6 week of gestation : up to 100 days
Cost
Time frame: From pregnancy test to ultrasound at 6 week of gestation : up to 100 days
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 6 Feb 2019.
- Background: PubMed 20579989Bjuresten K, Landgren BM, Hovatta O, Stavreus-Evers A. Luteal phase progesterone increases live birth rate after frozen embryo transfer. Fertil Steril. 2011 Feb;95(2):534-7. doi: 10.1016/j.fertnstert.2010.05.019. Epub 2010 Jun 26.
- Background: PubMed 21665875Boivin J, Takefman J, Braverman A. The fertility quality of life (FertiQoL) tool: development and general psychometric properties. Hum Reprod. 2011 Aug;26(8):2084-91. doi: 10.1093/humrep/der171. Epub 2011 Jun 10.
- Background: PubMed 18706550de La Rochebrochard E, Quelen C, Peikrishvili R, Guibert J, Bouyer J. Long-term outcome of parenthood project during in vitro fertilization and after discontinuation of unsuccessful in vitro fertilization. Fertil Steril. 2009 Jul;92(1):149-56. doi: 10.1016/j.fertnstert.2008.05.067. Epub 2008 Aug 15.
- Background: PubMed 25114675Eftekhar M, Rahmani E, Pourmasumi S. Evaluation of clinical factors influencing pregnancy rate in frozen embryo transfer. Iran J Reprod Med. 2014 Jul;12(7):513-8.
- Background: PubMed 22342107El Bahja D, Hertz P, Schweitzer T, Lestrade F, Ragage JP. [Frozen embryo transfer protocol: does spontaneous cycle give good results?]. Gynecol Obstet Fertil. 2013 Nov;41(11):648-52. doi: 10.1016/j.gyobfe.2011.08.007. Epub 2012 Feb 16. French.
- Background: PubMed 20097333Fatemi HM, Kyrou D, Bourgain C, Van den Abbeel E, Griesinger G, Devroey P. Cryopreserved-thawed human embryo transfer: spontaneous natural cycle is superior to human chorionic gonadotropin-induced natural cycle. Fertil Steril. 2010 Nov;94(6):2054-8. doi: 10.1016/j.fertnstert.2009.11.036. Epub 2010 Jan 25.
- Background: PubMed 23820515Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2.
- Background: PubMed 19246470Haouzi D, Assou S, Mahmoud K, Tondeur S, Reme T, Hedon B, De Vos J, Hamamah S. Gene expression profile of human endometrial receptivity: comparison between natural and stimulated cycles for the same patients. Hum Reprod. 2009 Jun;24(6):1436-45. doi: 10.1093/humrep/dep039. Epub 2009 Feb 26.
- Background: PubMed 8897131Nargund G, Wei CC. Successful planned delay of ovulation for one week with indomethacin. J Assist Reprod Genet. 1996 Sep;13(8):683-4. doi: 10.1007/BF02069650. No abstract available.
- Background: PubMed 17434509Park SJ, Goldsmith LT, Skurnick JH, Wojtczuk A, Weiss G. Characteristics of the urinary luteinizing hormone surge in young ovulatory women. Fertil Steril. 2007 Sep;88(3):684-90. doi: 10.1016/j.fertnstert.2007.01.045. Epub 2007 Apr 16.
- Background: PubMed 24744054Tobler KJ, Zhao Y, Weissman A, Majumdar A, Leong M, Shoham Z. Worldwide survey of IVF practices: trigger, retrieval and embryo transfer techniques. Arch Gynecol Obstet. 2014 Sep;290(3):561-8. doi: 10.1007/s00404-014-3232-6. Epub 2014 Apr 18.
- Background: PubMed 22840239Tomas C, Alsbjerg B, Martikainen H, Humaidan P. Pregnancy loss after frozen-embryo transfer--a comparison of three protocols. Fertil Steril. 2012 Nov;98(5):1165-9. doi: 10.1016/j.fertnstert.2012.07.1058. Epub 2012 Jul 27.
- 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.
Nathalie Massin, MD principal investigator
CHIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing natural cycle and moderate ovarian stimulation in people with Fertility, run by Dr Massin Nathalie at 1 site in France.
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 6 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 6 Feb 2019. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of visits (time frame: From inclusion visit to embryo transfer : up to 90 days). 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 NCT02834117, which also lists 15 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 6 Feb 2019.