Poor ResponderPhase 1NCT02575924
Influence of Culture Media on Clinical Outcomes in Poor Responders or Severe Male Infertility
A Phase 1 study testing sequential medium and 1-step medium in people with Poor Responder and Severe Male Infertility, run by European Hospital at 1 site in Italy.
Trial summary
In this study the suitability of two -sequential and single step- commercially available culture media from the same brand was compared. The aim of such study is to verify whether is possible to improve the efficiency of infertility treatments in those couples who usually have a high cycle cancellation rate, such as… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Poor Responder, Severe Male Infertility, Embryo Development
- What is being tested?
- sequential medium and 1-step medium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2015to Dec 2017
- Phase
- Phase 1
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- advanced maternal age,
- poor responder women (<=4 oocytes),
- cryptozoospermia,
- testicular retrieval of spermatozoa
Who cannot join
- any other
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Center for Reproductive Medicine
Rome, RM, 00149
Ermanno Greco, Medicine, +39-0665975318, grecoe@hotmail.it
Maria Giulia Minasi, Biology, +39-0665975659, mg.minasi@gmail.com
About this study
Official title: Employing a Single Step Media Can Improve the Clinical Outcomes in Those Patient Who Usually Show an High Cycle Cancellation Rate?
In this study the suitability of two -sequential and single step- commercially available culture media from the same brand was compared. The aim of such study is to verify whether is possible to improve the efficiency of infertility treatments in those couples who usually have a high cycle cancellation rate, such as poor responder patients and severe male infertility. The study population is composed of couples attending the fertility clinic: to this purpose all those couples approaching IVF treatments with a diagnosis of OAT, cryptozoospermia, advanced maternal age and women with a "poor responder" diagnosis were recruited. IVF treatments were randomly set to be cultured either with two-step sequential media or with one-step media to acquire data concerning the ongoing embryo culture development and clinical outcomes.
Read the detailed description
The final goal in the field of Assisted Reproductive Technology is to obtain a single healthy newborn. For that purpose, a lot of factors are strictly interconnected each other's and have to be carefully evaluated. The choice of embryo culture system and of embryo selection strategy plays a crucial role in obtain and identify the embryo with the highest implantation potential. One really important key factor is the choice of the culture media. Currently, there are numerous commercially available culture media showing very different compositions. Essentially two strategies have been applied for the design of culture media: 1) "Back to nature" for sequential media, based on the physiology of the embryo and the measured concentration of substances present in its natural environment and 2) "Let the embryo choose" for single step media, where none a priori assumption of the concentration of a component is made. In the literature, there are a lot of studies analyzing the effect of culture media on human preimplantation embryos development and comparing biological and clinical outcomes among different media compositions. Several studies performed a comparison about the development of human zygotes in either a one-step or two-step culture system. Usually there were no significant differences between the two culture media systems regarding biological or clinical outcomes. Anyway, a greater number of blastocysts were generally obtained by the continuous single medium culture if compared with sequential culture media, even if the implantation and clinical pregnancy rates are comparable.
- Being tested
- sequential medium, 1-step medium
- Keywords
- media, blastocyst, male infertility, poor responders, pgs
- Medical subject headings
- Infertility, Male, Mental Retardation, X-Linked 59
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequential mediumDrug
Also called Quinn's Advantage® Fertilization Medium, Quinn's Advantage® Cleavage Medium, Quinn's Advantage® Blastocyst Medium
administration of Quinn's Advantage® Fertilization Medium on day0 administration of Quinn's Advantage® Cleavage Medium from day0 to day3 administration of Quinn's Advantage® Blastocyst Medium from day3 to day7
1-step mediumDrug
Also called SAGE 1-Step™ with Human Albumin Solution
administration of SAGE 1-Step™ with Human Albumin Solution, from day0 to day7
| Study group | Role | What they receive |
|---|---|---|
| sequential medium female age>=40 | Active comparator | day 0: suitable number of test tubes, each one filled with 1ml of SAGE-FERT medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube)
1 or more culture dish with 6 droplets (35µl) of SAGE-CLEAVAGE medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day3
day3: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices and newer volumes of mineral oil to cover up the droplets till day5
day5: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices without any mineral oil replacement till day7 Receives: Drug: sequential medium |
| sequential medium female age<40 | Active comparator | day 0: suitable number of test tubes, each one filled with 1ml of SAGE-FERT medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube)
1 or more culture dish with 6 droplets (35µl) of SAGE-CLEAVAGE medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day3
day3: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices and newer volumes of mineral oil to cover up the droplets till day5
day5: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices without any mineral oil replacement till day7 Receives: Drug: sequential medium |
| sequential medium sperm testis retrieval | Active comparator | day 0: suitable number of test tubes, each one filled with 1ml of SAGE-FERT medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube)
1 or more culture dish with 6 droplets (35µl) of SAGE-CLEAVAGE medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day3
day3: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices and newer volumes of mineral oil to cover up the droplets till day5
day5: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices without any mineral oil replacement till day7 Receives: Drug: sequential medium |
| one step medium female age>=40 | Active comparator | day 0: suitable number of test tubes, each one filled with 1ml of SAGE 1-STEP medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube)
1 or more culture dish with 6 droplets (35µl) of SAGE 1-STEP medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day7 Receives: Drug: 1-step medium |
| one step medium female age<40 | Active comparator | day 0: suitable number of test tubes, each one filled with 1ml of SAGE 1-STEP medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube)
1 or more culture dish with 6 droplets (35µl) of SAGE 1-STEP medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day7 Receives: Drug: 1-step medium |
| one step medium sperm testis retrieval | Active comparator | day 0: suitable number of test tubes, each one filled with 1ml of SAGE 1-STEP medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube)
1 or more culture dish with 6 droplets (35µl) of SAGE 1-STEP medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day7 Receives: Drug: 1-step medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
blastocystis development rate
Measured: six months
implantation rate
Measured: six months
clinical pregnancy rate
total number of gestational chambers resulting from the total embryo transferred
Measured: one year
Secondary outcomes (1)
ploidy status
Embryo genetic status after chromosomal screening
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Poor ResponderStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MariaGiulia Minasi, Biology, Principal investigator, European Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575924
- Sponsor's protocol ID
- MGM13
- Status last verified
- Jan 2016
- First submitted
- 8 Oct 2015
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Basile N, Morbeck D, Garcia-Velasco J, Bronet F, Meseguer M. Type of culture media does not affect embryo kinetics: a time-lapse analysis of sibling oocytes. Hum Reprod. 2013 Mar;28(3):634-41. doi: 10.1093/humrep/des462. Epub 2013 Jan 12.
PubMed 23315059Biggers JD, Summers MC. Choosing a culture medium: making informed choices. Fertil Steril. 2008 Sep;90(3):473-83. doi: 10.1016/j.fertnstert.2008.08.010.
PubMed 18847602Chronopoulou E, Harper JC. IVF culture media: past, present and future. Hum Reprod Update. 2015 Jan-Feb;21(1):39-55. doi: 10.1093/humupd/dmu040. Epub 2014 Jul 17.
PubMed 25035437Ciray HN, Aksoy T, Goktas C, Ozturk B, Bahceci M. Time-lapse evaluation of human embryo development in single versus sequential culture media--a sibling oocyte study. J Assist Reprod Genet. 2012 Sep;29(9):891-900. doi: 10.1007/s10815-012-9818-7. Epub 2012 Jun 20.
PubMed 22714134Gardner DK, Lane M. One-step versus two-step culture of mouse preimplantation embryos. Hum Reprod. 2006 Jul;21(7):1935-6; author reply 1936-9. doi: 10.1093/humrep/del070. No abstract available.
PubMed 16818962Lane M, Gardner DK. Embryo culture medium: which is the best? Best Pract Res Clin Obstet Gynaecol. 2007 Feb;21(1):83-100. doi: 10.1016/j.bpobgyn.2006.09.009. Epub 2006 Nov 7.
PubMed 17090393Mantikou E, Youssef MA, van Wely M, van der Veen F, Al-Inany HG, Repping S, Mastenbroek S. Embryo culture media and IVF/ICSI success rates: a systematic review. Hum Reprod Update. 2013 May-Jun;19(3):210-20. doi: 10.1093/humupd/dms061. Epub 2013 Feb 5.
PubMed 23385469Reed ML, Hamic A, Thompson DJ, Caperton CL. Continuous uninterrupted single medium culture without medium renewal versus sequential media culture: a sibling embryo study. Fertil Steril. 2009 Nov;92(5):1783-6. doi: 10.1016/j.fertnstert.2009.05.008. Epub 2009 Jun 12.
PubMed 19523617Summers MC, Bird S, Mirzai FM, Thornhill A, Biggers JD. Human preimplantation embryo development in vitro: a morphological assessment of sibling zygotes cultured in a single medium or in sequential media. Hum Fertil (Camb). 2013 Dec;16(4):278-85. doi: 10.3109/14647273.2013.806823. Epub 2013 Jul 17.
PubMed 23862646
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Employing a Single Step Media Can Improve the Clinical Outcomes in Those Patient Who Usually Show an High Cycle Cancellation Rate?
- ClinicalTrials.gov ID
- NCT02575924
- Acronym / sponsor ID
- MGM13
- Keywords
- media, blastocyst, male infertility, poor responders, pgs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- European HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Oct 2015 (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.
In this study the suitability of two -sequential and single step- commercially available culture media from the same brand was compared. The aim of such study is to verify whether is possible to improve the efficiency of infertility treatments in those couples who usually have a high cycle cancellation rate, such as poor responder patients and severe male infertility. The study population is composed of couples attending the fertility clinic: to this purpose all those couples approaching IVF treatments with a diagnosis of OAT, cryptozoospermia, advanced maternal age and women with a "poor responder" diagnosis were recruited. IVF treatments were randomly set to be cultured either with two-step sequential media or with one-step media to acquire data concerning the ongoing embryo culture development and clinical outcomes.
Detailed description
The final goal in the field of Assisted Reproductive Technology is to obtain a single healthy newborn. For that purpose, a lot of factors are strictly interconnected each other's and have to be carefully evaluated. The choice of embryo culture system and of embryo selection strategy plays a crucial role in obtain and identify the embryo with the highest implantation potential. One really important key factor is the choice of the culture media. Currently, there are numerous commercially available culture media showing very different compositions. Essentially two strategies have been applied for the design of culture media: 1) "Back to nature" for sequential media, based on the physiology of the embryo and the measured concentration of substances present in its natural environment and 2) "Let the embryo choose" for single step media, where none a priori assumption of the concentration of a component is made. In the literature, there are a lot of studies analyzing the effect of culture media on human preimplantation embryos development and comparing biological and clinical outcomes among different media compositions. Several studies performed a comparison about the development of human zygotes in either a one-step or two-step culture system. Usually there were no significant differences between the two culture media systems regarding biological or clinical outcomes. Anyway, a greater number of blastocysts were generally obtained by the continuous single medium culture if compared with sequential culture media, even if the implantation and clinical pregnancy rates are comparable.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| sequential medium female age>=40 | Active comparator | Drug: sequential mediumday 0: suitable number of test tubes, each one filled with 1ml of SAGE-FERT medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube) 1 or more culture dish with 6 droplets (35µl) of SAGE-CLEAVAGE medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day3 day3: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices and newer volumes of mineral oil to cover up the droplets till day5 day5: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices without any mineral oil replacement till day7 |
| sequential medium female age<40 | Active comparator | Drug: sequential mediumday 0: suitable number of test tubes, each one filled with 1ml of SAGE-FERT medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube) 1 or more culture dish with 6 droplets (35µl) of SAGE-CLEAVAGE medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day3 day3: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices and newer volumes of mineral oil to cover up the droplets till day5 day5: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices without any mineral oil replacement till day7 |
| sequential medium sperm testis retrieval | Active comparator | Drug: sequential mediumday 0: suitable number of test tubes, each one filled with 1ml of SAGE-FERT medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube) 1 or more culture dish with 6 droplets (35µl) of SAGE-CLEAVAGE medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day3 day3: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices and newer volumes of mineral oil to cover up the droplets till day5 day5: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices without any mineral oil replacement till day7 |
| one step medium female age>=40 | Active comparator | Drug: 1-step mediumday 0: suitable number of test tubes, each one filled with 1ml of SAGE 1-STEP medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube) 1 or more culture dish with 6 droplets (35µl) of SAGE 1-STEP medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day7 |
| one step medium female age<40 | Active comparator | Drug: 1-step mediumday 0: suitable number of test tubes, each one filled with 1ml of SAGE 1-STEP medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube) 1 or more culture dish with 6 droplets (35µl) of SAGE 1-STEP medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day7 |
| one step medium sperm testis retrieval | Active comparator | Drug: 1-step mediumday 0: suitable number of test tubes, each one filled with 1ml of SAGE 1-STEP medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube) 1 or more culture dish with 6 droplets (35µl) of SAGE 1-STEP medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day7 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- advanced maternal age,
- poor responder women (<=4 oocytes),
- cryptozoospermia,
- testicular retrieval of spermatozoa
Key exclusion criteria (1 listed)
- any other
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 |
|---|---|---|
| sequential mediumAlso: Quinn's Advantage® Fertilization Medium, Quinn's Advantage® Cleavage Medium, Quinn's Advantage® Blastocyst Mediumadministration of Quinn's Advantage® Fertilization Medium on day0 administration of Quinn's Advantage® Cleavage Medium from day0 to day3 administration of Quinn's Advantage® Blastocyst Medium from day3 to day7 | Drug | sequential medium female age<40, sequential medium female age>=40, sequential medium sperm testis retrieval |
| 1-step mediumAlso: SAGE 1-Step™ with Human Albumin Solutionadministration of SAGE 1-Step™ with Human Albumin Solution, from day0 to day7 | Drug | one step medium female age<40, one step medium female age>=40, one step medium sperm testis retrieval |
Primary outcome
blastocystis development rate
Time frame: six months
implantation rate
Time frame: six months
clinical pregnancy rate
Time frame: one year
total number of gestational chambers resulting from the total embryo transferred
1 secondary outcome
ploidy status
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Background: PubMed 23315059Basile N, Morbeck D, Garcia-Velasco J, Bronet F, Meseguer M. Type of culture media does not affect embryo kinetics: a time-lapse analysis of sibling oocytes. Hum Reprod. 2013 Mar;28(3):634-41. doi: 10.1093/humrep/des462. Epub 2013 Jan 12.
- Background: PubMed 18847602Biggers JD, Summers MC. Choosing a culture medium: making informed choices. Fertil Steril. 2008 Sep;90(3):473-83. doi: 10.1016/j.fertnstert.2008.08.010.
- Background: PubMed 25035437Chronopoulou E, Harper JC. IVF culture media: past, present and future. Hum Reprod Update. 2015 Jan-Feb;21(1):39-55. doi: 10.1093/humupd/dmu040. Epub 2014 Jul 17.
- Background: PubMed 22714134Ciray HN, Aksoy T, Goktas C, Ozturk B, Bahceci M. Time-lapse evaluation of human embryo development in single versus sequential culture media--a sibling oocyte study. J Assist Reprod Genet. 2012 Sep;29(9):891-900. doi: 10.1007/s10815-012-9818-7. Epub 2012 Jun 20.
- Background: PubMed 16818962Gardner DK, Lane M. One-step versus two-step culture of mouse preimplantation embryos. Hum Reprod. 2006 Jul;21(7):1935-6; author reply 1936-9. doi: 10.1093/humrep/del070. No abstract available.
- Background: PubMed 17090393Lane M, Gardner DK. Embryo culture medium: which is the best? Best Pract Res Clin Obstet Gynaecol. 2007 Feb;21(1):83-100. doi: 10.1016/j.bpobgyn.2006.09.009. Epub 2006 Nov 7.
- Background: PubMed 23385469Mantikou E, Youssef MA, van Wely M, van der Veen F, Al-Inany HG, Repping S, Mastenbroek S. Embryo culture media and IVF/ICSI success rates: a systematic review. Hum Reprod Update. 2013 May-Jun;19(3):210-20. doi: 10.1093/humupd/dms061. Epub 2013 Feb 5.
- Background: PubMed 19523617Reed ML, Hamic A, Thompson DJ, Caperton CL. Continuous uninterrupted single medium culture without medium renewal versus sequential media culture: a sibling embryo study. Fertil Steril. 2009 Nov;92(5):1783-6. doi: 10.1016/j.fertnstert.2009.05.008. Epub 2009 Jun 12.
- Background: PubMed 23862646Summers MC, Bird S, Mirzai FM, Thornhill A, Biggers JD. Human preimplantation embryo development in vitro: a morphological assessment of sibling zygotes cultured in a single medium or in sequential media. Hum Fertil (Camb). 2013 Dec;16(4):278-85. doi: 10.3109/14647273.2013.806823. Epub 2013 Jul 17.
Related trials for Poor Responder
RecruitingObservational study
BEst Size for Ovulation Triggering in Poseidon 4 Patients (BEST 4 Study)
Fertilization, Fertilization in Vitro
RecruitingPhase 2
Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)
Cutaneous Melanoma, Mucosal Melanoma
Not yet recruiting
Evaluation of Pregnancy Outcome with Usage of Drug-free In-vitro Activation of Follicles Ovary
Infertility (IVF Patients), Infertile Females or Females with Ovarian Insufficiency
RecruitingPhase 4
Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis
Hepatitis B, Cirrhosis, Liver
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.
MariaGiulia Minasi, Biology principal investigator
European Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sequential medium and 1-step medium in people with Poor Responder and Severe Male Infertility, run by European Hospital at 1 site in Italy.
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 4 inclusion and 1 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 15 Jan 2016. 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 Italy. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ermanno Greco, Medicine (0665975318, grecoe@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blastocystis development rate (time frame: six months). The study lists 3 primary outcomes in all. 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 NCT02575924, which also lists 9 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 15 Jan 2016.