InfertilityPOAM-RCTNCT03717805
The Evaluation of a Preparatory Information Movie on Oocyte Aspiration
A study testing POAM in people with Infertility, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The Preparatory information on Oocyte Aspiration Movie Randomized Controlled Trial (POAM-RCT) primarily aims to evaluate whether a new preparatory information on oocyte aspiration movie (POAM) decreases the anxiety of women on the day of their first oocyte aspiration for in vitro fertilisation (IVF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infertility
- What is being tested?
- POAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Oct 2018to 24 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heterosexual woman and her partner
- Dutch speaking
- Treated with a 1st cycle of IVF (IVF or ICSI; with or without PGD)
Who cannot join
- Having already experienced an IVF-cycle in the same of another clinic
Trial locations and contacts
1 site in 1 country.
Belgium1 site
GZA Ziekenhuizen campus Sint-Augustinus
Wilrijk, Antwerpen, 2610
About this study
Official title: The Evaluation of a Preparatory Information Movie on Oocyte Aspiration: a Randomized Controlled Trial
The Preparatory information on Oocyte Aspiration Movie Randomized Controlled Trial (POAM-RCT) primarily aims to evaluate whether a new preparatory information on oocyte aspiration movie (POAM) decreases the anxiety of women on the day of their first oocyte aspiration for in vitro fertilisation (IVF). The control group of this RCT will receive care as usual. The intervention group will additional be given access to a preparatory information movie on oocyte aspiration 1-3 days before their oocyte aspiration via a secured link. Women's anxiety will be assessed with the 'State module of the State Trait Anxiety Inventory (STAI-state)' upon arrival at the fertility clinic on the day of the oocyte aspiration. At the same time other questionnaires will be administered. More specifically, men's anxiety and both partner's infertility specific distress will be assessed. In addition, to these secondary outcomes, clinical pregnancy with fetal heart beat and miscarriage will be followed-up 12 weeks after the oocyte aspiration. Finally, treatment delay and treatment discontinuation and long-term clinical outcomes (i.e. live birth from the first fresh embryo transfer, clinical pregnancy with fetal heart beat from the frozen embryo transfers of 1st IVF-cycle and the 12-months cumulative clinical pregnancy rates) will be followed-up twelve months after oocyte aspiration. This RCT will include 190 women (and their male partners) treated with a 1st cycle of IVF (with or without ICSI and PGD). Analysis will be according to intention to treat.
Read the detailed description
Title: The evaluation of a preparatory information movie on oocyte aspiration: a Randomized Controlled Trial (POAM-RCT) Study purpose: To evaluate whether the preparatory information movie on oocyte aspiration (POAM) decreases the anxiety of ART-couples on the day of their first oocyte aspiration.
Primary outcome: The primary outcome is women's 'state anxiety', which will be assessed with the reliable 'State Trait Anxiety Inventory, state module (STAI-state)' questionnaire upon arrival at the fertility clinic on the day of the oocyte aspiration.
Secondary outcomes: Three secondary patient-reported outcomes will be assessed simultaneously with the primary outcome, upon arrival at the fertility clinic for oocyte aspiration.
First, men's state anxiety will assessed with the STAI-state questionnaire. Second and third, in both women and men, infertility-specific distress will be assessed.
The following two secondary clinical outcomes will be followed-up in all couples 12 weeks after the oocyte aspiration: clinical pregnancy with fetal heart beat and miscarriage in case of clinical pregnancy with fetal heart beat.
Other outcomes: As a follow-up the following will be extracted from the medical charts of participating couples twelve months after the oocyte aspiration: long-term clinical outcomes (i.e. live birth from the first fresh embryo transfer, clinical pregnancy with fetal heart beat from the frozen embryo transfers of 1st IVF-cycle and the 12-months cumulative clinical pregnancy rates) and long-term discontinuation parameters (i.e. censored by their medical doctor to discontinue, IVF-delay or number of untreated cycles within 12 months and IVF-discontinuation or whether or not start a 2nd IVF-cycle was started within 12 months).
Study design: Randomized controlled trial Sample size: 190 couples will be randomized to the intervention or control group Summary of eligibility criteria: Inclusion criteria: Couples treated with a 1st cycle of ART (IVF or ICSI; with or without PGD). Couples with a genetic indication for PGD can be included as they are an important patient group and are as likely as infertile patients to experience anxiety when they first come for oocyte retrieval.
Exclusion criterion: Couples going through a subsequent cycle of ART are not eligible as they are not treatment naïve, but already know, from their first cycle, what will happen on the day of oocyte aspiration.
Maximum duration of treatment of a subject: Each couple will participate from their ART-intake until the day of their first oocyte aspiration.
Couples will be asked for informed consent during their ART-intake (i.e. individual or group session with midwife; 1-3 months prior to oocyte aspiration) and will then be randomized to either the intervention group or the control group.
Participating couples of the intervention group will receive care as usual and will watch the preparatory information movie on oocyte aspiration (POAM) 1-3 days before their oocyte aspiration. Their gynecologist or midwife will empower them to watch the movie when they call them to plan the oocyte aspiration and will send them the secured link to the movie via email.
Participating couples of the control group will receive care as usual (as will participating couples of the intervention group) and will not get access to the preparatory information movie on oocyte aspiration (POAM).
When they arrive at the fertility clinic on the day of oocyte aspiration both partners of participating couples of the intervention and control group will be asked to fill out a questionnaire (5-10 minutes) before any clinical procedures are performed.
- Conditions
- Infertility
- Being tested
- POAM
- Keywords
- Patient-centered care, Patient information
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POAMOther
The new 5 minutes preparatory information movie on oocyte aspiration (POAM) details what couples can expect to happen on the day of oocyte aspiration. More specifically, it describes the patient journey detailing which procedures will happen when and how, in which room, in the presence of their partner or not, and in the presence of which healthcare professionals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participating couples of the intervention group will receive care as usual and will watch the preparatory information movie on oocyte aspiration (POAM) 1-3 days before their oocyte aspiration. Their gynecologist or midwife will empower them to watch the movie when they call them to plan the oocyte aspiration and will send them the secured link to the movie via email. Receives: Other: POAM |
| Control group | No intervention | Participating couples of the control group will receive care as usual (as will participating couples of the intervention group) and will not get access to the preparatory information movie on oocyte aspiration (POAM). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Women's state anxiety
Women's anxiety will be assessed with the 'State Trait Anxiety Inventory, state module (STAI-state; score 20-80, the higher the more anxious)' questionnaire (Spielberger et al, 2015; www.mingarden.com).
Measured: Responses on one single assessment of state-anxiety on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
Secondary outcomes (10)
Men's state anxiety
Men's anxiety will be assessed with the 'State Trait Anxiety Inventory, state module (STAI-state; score 20-80, the higher the more anxious)' questionnaire (Spielberger et al, 2015; www.mingarden.com)
Measured: Responses on one single assessment of state-anxiety on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
Women's infertility specific distress
Women's infertility-specific distress will be assessed with the reliable 'Infertility Distress Scale (IDS; score 8-40 with the higher, the more distress)' (Pook\&Krause, Fertil Steril, 2005)
Measured: Responses on one single assessment of distress on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
Men's infertility specific stress
Men's infertility-specific distress will be assessed with the reliable 'Infertility Distress Scale (IDS; score 8-40 with the higher, the more distress)' (Pook\&Krause, Fertil Steril, 2005)
Measured: Responses on one single assessment of distress on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
Clinical pregnancy with fetal heart beat
A pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat (Zegers-Hochschild et al, Hum Reprod, 2017).
Measured: A medium duration after intervention or control condition: 12 weeks after oocyte aspiration
Miscarriage after clinical pregnancy with fetal heart beat
A miscarriage after a pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat (Zegers-Hochschild et al, Hum Reprod, 2017).
Measured: A medium duration after intervention or control condition: 12 weeks after oocyte aspiration
Live birth from the first fresh embryo transfer
Dichotomous outcome (yes-no), which is achieved if the first fresh embryo transfer results in a live birth. More specifically, the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. Live births refer to the individual newborn; for example, a twin delivery represents two live births (Zegers-Hochschild et al, Hum Reprod, 2017).
Measured: A long duration after intervention or control condition: One year after oocyte aspiration
Clinical pregnancy with fetal heart beat from the frozen embryo transfers of 1st IVF-cycle
Dichotomous outcome (yes-no), which is achieved if at least one clinical pregnancy with fetal heart beat is conceived after the transfer of embryos which have been frozen as a result of the first oocyte aspiration (Zegers-Hochschild et al, Hum Reprod, 2017).
Measured: A long duration after intervention or control condition: One year after oocyte aspiration
12-months cumulative clinical pregnancy with fetal heart beat
Dichotomous outcome (yes-no), which is achieved if at least one clinical pregnancy with fetal heart beat is conceived within 12-months after oocyte aspiration
Measured: A long duration after intervention or control condition: One year after oocyte aspiration
IVF-delay or number of untreated cycles within 12 months
The number of untreated cycles within 12 months after an unsuccessful oocyte aspiration
Measured: A long duration after intervention or control condition: One year after oocyte aspiration
IVF-discontinuation
Dichotomous outcome (yes-no), which is achieved if a couple decides themselves (without censored by their gynaecologist) not to start a second oocyte aspiration within 12 months after their first unsuccessful oocyte aspiration
Measured: A long duration after intervention or control condition: One year after oocyte aspiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start29 Oct 2018
- Primary completion24 Sep 2020
- Study completion24 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial (1/1)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- GZA Ziekenhuizen Campus Sint-Augustinus
- Responsible party
- Sponsor
- Investigators
- Karen Peeraer, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717805
- Sponsor's protocol ID
- s61509
- Acronym
- POAM-RCT
- Status last verified
- Jul 2024
- First submitted
- 10 Oct 2018
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dias L, De Loecker P, Willems S, D'Hooghe TM, Vriens J, Peeraer K, Dancet EAF. A video clip detailing the patient journey on the day of oocyte retrieval in addition to the standard of care: a randomized controlled trial. Hum Reprod. 2025 Apr 1;40(4):664-674. doi: 10.1093/humrep/deaf033.
PubMed 40056004
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a Preparatory Information Movie on Oocyte Aspiration: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03717805
- Acronym / sponsor ID
- POAM-RCT / s61509
- Conditions
- Infertility
- Keywords
- Patient-centered care, Patient information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- GZA Ziekenhuizen Campus Sint-Augustinus
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2022 (actual)
- First posted
- 24 Oct 2018 (actual)
- 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 Preparatory information on Oocyte Aspiration Movie Randomized Controlled Trial (POAM-RCT) primarily aims to evaluate whether a new preparatory information on oocyte aspiration movie (POAM) decreases the anxiety of women on the day of their first oocyte aspiration for in vitro fertilisation (IVF). The control group of this RCT will receive care as usual. The intervention group will additional be given access to a preparatory information movie on oocyte aspiration 1-3 days before their oocyte aspiration via a secured link. Women's anxiety will be assessed with the 'State module of the State Trait Anxiety Inventory (STAI-state)' upon arrival at the fertility clinic on the day of the oocyte aspiration. At the same time other questionnaires will be administered. More specifically, men's anxiety and both partner's infertility specific distress will be assessed. In addition, to these secondary outcomes, clinical pregnancy with fetal heart beat and miscarriage will be followed-up 12 weeks after the oocyte aspiration. Finally, treatment delay and treatment discontinuation and long-term clinical outcomes (i.e. live birth from the first fresh embryo transfer, clinical pregnancy with fetal heart beat from the frozen embryo transfers of 1st IVF-cycle and the 12-months cumulative clinical pregnancy rates) will be followed-up twelve months after oocyte aspiration. This RCT will include 190 women (and their male partners) treated with a 1st cycle of IVF (with or without ICSI and PGD). Analysis will be according to intention to treat.
Detailed description
Title: The evaluation of a preparatory information movie on oocyte aspiration: a Randomized Controlled Trial (POAM-RCT) Study purpose: To evaluate whether the preparatory information movie on oocyte aspiration (POAM) decreases the anxiety of ART-couples on the day of their first oocyte aspiration.
Primary outcome: The primary outcome is women's 'state anxiety', which will be assessed with the reliable 'State Trait Anxiety Inventory, state module (STAI-state)' questionnaire upon arrival at the fertility clinic on the day of the oocyte aspiration.
Secondary outcomes: Three secondary patient-reported outcomes will be assessed simultaneously with the primary outcome, upon arrival at the fertility clinic for oocyte aspiration.
First, men's state anxiety will assessed with the STAI-state questionnaire. Second and third, in both women and men, infertility-specific distress will be assessed.
The following two secondary clinical outcomes will be followed-up in all couples 12 weeks after the oocyte aspiration: clinical pregnancy with fetal heart beat and miscarriage in case of clinical pregnancy with fetal heart beat.
Other outcomes: As a follow-up the following will be extracted from the medical charts of participating couples twelve months after the oocyte aspiration: long-term clinical outcomes (i.e. live birth from the first fresh embryo transfer, clinical pregnancy with fetal heart beat from the frozen embryo transfers of 1st IVF-cycle and the 12-months cumulative clinical pregnancy rates) and long-term discontinuation parameters (i.e. censored by their medical doctor to discontinue, IVF-delay or number of untreated cycles within 12 months and IVF-discontinuation or whether or not start a 2nd IVF-cycle was started within 12 months).
Study design: Randomized controlled trial Sample size: 190 couples will be randomized to the intervention or control group Summary of eligibility criteria: Inclusion criteria: Couples treated with a 1st cycle of ART (IVF or ICSI; with or without PGD). Couples with a genetic indication for PGD can be included as they are an important patient group and are as likely as infertile patients to experience anxiety when they first come for oocyte retrieval.
Exclusion criterion: Couples going through a subsequent cycle of ART are not eligible as they are not treatment naïve, but already know, from their first cycle, what will happen on the day of oocyte aspiration.
Maximum duration of treatment of a subject: Each couple will participate from their ART-intake until the day of their first oocyte aspiration.
Couples will be asked for informed consent during their ART-intake (i.e. individual or group session with midwife; 1-3 months prior to oocyte aspiration) and will then be randomized to either the intervention group or the control group.
Participating couples of the intervention group will receive care as usual and will watch the preparatory information movie on oocyte aspiration (POAM) 1-3 days before their oocyte aspiration. Their gynecologist or midwife will empower them to watch the movie when they call them to plan the oocyte aspiration and will send them the secured link to the movie via email.
Participating couples of the control group will receive care as usual (as will participating couples of the intervention group) and will not get access to the preparatory information movie on oocyte aspiration (POAM).
When they arrive at the fertility clinic on the day of oocyte aspiration both partners of participating couples of the intervention and control group will be asked to fill out a questionnaire (5-10 minutes) before any clinical procedures are performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial (1/1)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: POAMParticipating couples of the intervention group will receive care as usual and will watch the preparatory information movie on oocyte aspiration (POAM) 1-3 days before their oocyte aspiration. Their gynecologist or midwife will empower them to watch the movie when they call them to plan the oocyte aspiration and will send them the secured link to the movie via email. |
| Control group | No intervention | –Participating couples of the control group will receive care as usual (as will participating couples of the intervention group) and will not get access to the preparatory information movie on oocyte aspiration (POAM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Heterosexual woman and her partner
- Dutch speaking
- Treated with a 1st cycle of IVF (IVF or ICSI; with or without PGD)
Key exclusion criteria (1 listed)
- Having already experienced an IVF-cycle in the same of another clinic
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 |
|---|---|---|
| POAMThe new 5 minutes preparatory information movie on oocyte aspiration (POAM) details what couples can expect to happen on the day of oocyte aspiration. More specifically, it describes the patient journey detailing which procedures will happen when and how, in which room, in the presence of their partner or not, and in the presence of which healthcare professionals. | Other | Intervention group |
Primary outcome
Women's state anxiety
Time frame: Responses on one single assessment of state-anxiety on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
Women's anxiety will be assessed with the 'State Trait Anxiety Inventory, state module (STAI-state; score 20-80, the higher the more anxious)' questionnaire (Spielberger et al, 2015; www.mingarden.com).
10 secondary outcomes
Men's state anxiety
Time frame: Responses on one single assessment of state-anxiety on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
Women's infertility specific distress
Time frame: Responses on one single assessment of distress on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
Men's infertility specific stress
Time frame: Responses on one single assessment of distress on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
Clinical pregnancy with fetal heart beat
Time frame: A medium duration after intervention or control condition: 12 weeks after oocyte aspiration
Miscarriage after clinical pregnancy with fetal heart beat
Time frame: A medium duration after intervention or control condition: 12 weeks after oocyte aspiration
Live birth from the first fresh embryo transfer
Time frame: A long duration after intervention or control condition: One year after oocyte aspiration
Clinical pregnancy with fetal heart beat from the frozen embryo transfers of 1st IVF-cycle
Time frame: A long duration after intervention or control condition: One year after oocyte aspiration
12-months cumulative clinical pregnancy with fetal heart beat
Time frame: A long duration after intervention or control condition: One year after oocyte aspiration
IVF-delay or number of untreated cycles within 12 months
Time frame: A long duration after intervention or control condition: One year after oocyte aspiration
IVF-discontinuation
Time frame: A long duration after intervention or control condition: One year after oocyte aspiration
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 20 Aug 2024.
- Derived from this study: PubMed 40056004Dias L, De Loecker P, Willems S, D'Hooghe TM, Vriens J, Peeraer K, Dancet EAF. A video clip detailing the patient journey on the day of oocyte retrieval in addition to the standard of care: a randomized controlled trial. Hum Reprod. 2025 Apr 1;40(4):664-674. doi: 10.1093/humrep/deaf033.
- 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.
Karen Peeraer, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POAM in people with Infertility, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 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: finished, as of the sponsor's last update on 20 Aug 2024. 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 Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Women's state anxiety (time frame: Responses on one single assessment of state-anxiety on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.). 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 NCT03717805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.