InfertilityPhase 4NCT04507022
The Outcome of Two Protocols Used to Prepare Endometrium for Frozen Embryo Transfer
A Phase 4 study testing Estradiol Valerate, Progesterone and Aromatase inhibitor in people with Infertility and Infertility, Female, run by Rahem Fertility Center at 1 site in Egypt.
Trial summary
This is a RCT to test the outcome of two protocols used for preparation of the endometrium for frozen blastocyst embryo transfer Read more about this study
- Who is it for?
- Ages 18 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Infertility, Female, Infertility, Male
- What is being tested?
- Estradiol Valerate, Progesterone and Aromatase inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2020to 5 Feb 2021
- 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 18 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged from18 - 37 years old undergoing FET using good quality blastocysts vitrified on day 5(3 BB and more) (according to Gardner and Schoolcraft 1999) (8).
- Participants having at least one good quality blastocyst (3BB and more) available for transfer after warming.
- Participants having trilaminar endometrium of 9 mm after E2 preparation.
Who cannot join
- Women younger than 18 or older than 37 years old.
- Women who have uterine abnormality or pathology.
- Women who will not meet the inclusion criteria.
- Women who will refuse to participate in in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study to Compare the Outcome of Two Protocols Used to Prepare the Endometrium for Frozen Embryo Transfer
This is a RCT to test the outcome of two protocols used for preparation of the endometrium for frozen blastocyst embryo transfer
Read the detailed description
Receptive endometrium and a good quality embryo at the blastocyst developmental stage are prerequisites for a successful implantation to occur. Blastocyst freezing techniques and survival have witnessed huge improvements in the last years. Trials to improve the outcome of frozen embryo transfer (FET) are not to be stopped. The transfer of a good quality blastocyst represents a vital part of the process. Optimization of endometrial receptivity and implantation is an everlasting challenge.
Hormone replacement therapy (HRT) is now proven to be successful for preparation of the endometrium to receive the vitrified warmed embryos. Most HRT protocols give estradiol (E2) first to reach a satisfactory endometrial thickness, then followed by progesterone to mimic the natural cycles. E2 is mostly given for 10 to 14 days and this duration might be prolonged to reach a satisfactory endometrial thickness without adversely affecting the outcome. Trans-vaginal ultrasound assessment of the endometrial thickness before the start of P supplementation has been traditionally used to predict FET cycle outcome. Clinical pregnancy rates (CPR) and live birth rates (LBR) were found to decrease for each millimetre of endometrial thickness below 7 mm. Endometrial thickness however of 9 mm was reported to be among major factors affecting LBR after FET in a large set of data.
Further, there is a recent concept that endometrial compaction (decreased thickness) between the end of estrogen phase and the day of ET has favorable impact on the outcome of FET. Different modalities were proposed to enhance endometrial compaction. One of these modalities was to decrease the dose of estrogen so as to change the estrogen- progesterone ratio as well as help in preventing further endometrial growth.
Aromatase inhibitor (AI) can be used to decrease estrogen before starting P supplementation. Additionally, there were also reports that their use had been associated with improved implantation. It appears interesting to combine the easy scheduled HRT protocol with aromatase inhibitor to maximize FET outcome.
This proposed protocol has not been tested before. In current study, HRT plus AI will be compared with HRT only. In both groups, daily intramuscular P will be given for luteal support as it was shown to give the highest ongoing pregnancy rate in FET cycles.
We did a secondary follow up analysis of some exploratory outcomes (not preregistered). These outcomes were analyzed after publication and they include Live birth rate, implantation rate, hypertensive disorders of pregnancy, large for gestation and congenital anomalies. The results of these outcomes are planned to be presented elsewhere. For openness and transparency, we felt the importance to report this follow up in the registry.
- Conditions
- Infertility, Infertility, Female, Infertility, Male
- Being tested
- Estradiol Valerate, Progesterone, Aromatase inhibitor
- Medical subject headings
- Infertility, Infertility, Female, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol ValerateDrug
2mg three times daily
ProgesteroneDrug
100 mg daily intramuscular
Aromatase inhibitorDrug
2.5 mg twice daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| HRT Plus Aromatase Inhibitor | Experimental | Hormone replacement treatment (HRT) will be used in all cases. Exogenous estradiol will be started on day 2 or 3 of the cycle. In all participants, 2 mg oral estradiol valerate, will be administered three times daily. Ultrasound evaluation of endometrium will be performed 10 to 12 days after starting E2. Trilaminar endometrium of 9 mm will be the targeted cutoff . If not yet ready, E2 supplementation will be continued with serial US assessment until the desired cutoff is achieved. Thereafter, participants will be randomized to two groups:
Group A (HRT plus AI): will be given aromatase inhibitor for 5 days only (2.5 mg twice daily), along with the oral 6 mg E2. Then, daily intramuscular (IM) P in oil (100 mg IM P) will be started in addition to the daily dose of oral 6 mg E2.
In both groups, embryos will be warmed on the 6th day of P supplementation. Before undergoing FET, endometrial thickness will be re-evaluated. IM P and 6mg E2 will be continued thereafter. Receives: Drug: Estradiol Valerate; Drug: Progesterone; Drug: Aromatase inhibitor |
| HRT Only | Active comparator | Hormone replacement treatment (HRT) will be used in all cases. Exogenous estradiol will be started on day 2 or 3 of the cycle. In all participants, 2 mg oral estradiol valerate, will be administered three times daily. Ultrasound evaluation of endometrium will be performed 10 to 12 days after starting E2. Trilaminar endometrium of 9 mm will be the targeted cutoff . If not yet ready, E2 supplementation will be continued with serial US assessment until the desired cutoff is achieved. Thereafter, participants will be randomized to two groups Group B (HRT only): will be administered daily intramuscular (IM) P in oil (100 mg IM P) in addition to the daily dose of oral 6 mg E2.
In both groups, embryos will be warmed on the 6th day of P supplementation. Before undergoing FET, endometrial thickness will be re-evaluated. IM P and 6mg E2 will be continued thereafter. Receives: Drug: Estradiol Valerate; Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing Pregnancy Rate
visualization of fetal cardiac pulsation by ultrasound
Measured: at 12 weeks of gestation
Secondary outcomes (7)
endometrial compaction
change in endometrial thickness
Measured: from the end of estradiol phase to the day of embryo transfer up to 11 days
clinical pregnancy rate
visualization of fetal cardiac pulsation by ultrasound
Measured: 6 weeks gestation
Live birth rate
The birth of at least one newborn that exhibits any sign of life
Measured: 24 weeks
Implantation rate
The number of gestational sacs observed divided by the number of embryos transferred expressed as a percentage, %
Measured: 6 weeks gestation
Number of participants with Hypertensive disorders of pregnancy
gestational hypertension or preeclampsia
Measured: 20 weeks gestation till postpartum
Number of participants with Large for gestational age
A birth weight greater than the 90th centile of the sex-specific birth weight for a given gestational age reference.
Measured: from gestation till delivery]
Rate of Congenital anomalies
Structural or functional disorders that occur during intra-uterine life and can be identified prenatally, at birth or later in life.
Measured: during pregnancy and after birth (one month after birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start12 Aug 2020
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rahem Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507022
- Sponsor's protocol ID
- RFC041120190008
- Status last verified
- Oct 2020
- First submitted
- 1 Aug 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mackens S, Santos-Ribeiro S, van de Vijver A, Racca A, Van Landuyt L, Tournaye H, Blockeel C. Frozen embryo transfer: a review on the optimal endometrial preparation and timing. Hum Reprod. 2017 Nov 1;32(11):2234-2242. doi: 10.1093/humrep/dex285.
PubMed 29025055Sekhon L, Feuerstein J, Pan S, Overbey J, Lee JA, Briton-Jones C, Flisser E, Stein DE, Mukherjee T, Grunfeld L, Sandler B, Copperman AB. Endometrial preparation before the transfer of single, vitrified-warmed, euploid blastocysts: does the duration of estradiol treatment influence clinical outcome? Fertil Steril. 2019 Jun;111(6):1177-1185.e3. doi: 10.1016/j.fertnstert.2019.02.024. Epub 2019 Apr 24.
PubMed 31029432Liu KE, Hartman M, Hartman A, Luo ZC, Mahutte N. The impact of a thin endometrial lining on fresh and frozen-thaw IVF outcomes: an analysis of over 40 000 embryo transfers. Hum Reprod. 2018 Oct 1;33(10):1883-1888. doi: 10.1093/humrep/dey281.
PubMed 30239738Pan Y, Hao G, Wang Q, Liu H, Wang Z, Jiang Q, Shi Y, Chen ZJ. Major Factors Affecting the Live Birth Rate After Frozen Embryo Transfer Among Young Women. Front Med (Lausanne). 2020 Mar 24;7:94. doi: 10.3389/fmed.2020.00094. eCollection 2020.
PubMed 32266278Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.
PubMed 31248618Devine K, Richter KS, Widra EA, McKeeby JL. Vitrified blastocyst transfer cycles with the use of only vaginal progesterone replacement with Endometrin have inferior ongoing pregnancy rates: results from the planned interim analysis of a three-arm randomized controlled noninferiority trial. Fertil Steril. 2018 Feb;109(2):266-275. doi: 10.1016/j.fertnstert.2017.11.004. Epub 2018 Jan 17.
PubMed 29338855Miller PB, Parnell BA, Bushnell G, Tallman N, Forstein DA, Higdon HL 3rd, Kitawaki J, Lessey BA. Endometrial receptivity defects during IVF cycles with and without letrozole. Hum Reprod. 2012 Mar;27(3):881-8. doi: 10.1093/humrep/der452. Epub 2012 Jan 13.
PubMed 22246449Gardner DK, Schoolcraft WB. Culture and transfer of human blastocysts. Curr Opin Obstet Gynecol. 1999 Jun;11(3):307-11. doi: 10.1097/00001703-199906000-00013.
PubMed 10369209
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Compare the Outcome of Two Protocols Used to Prepare the Endometrium for Frozen Embryo Transfer
- ClinicalTrials.gov ID
- NCT04507022
- Acronym / sponsor ID
- RFC041120190008
- Conditions
- Infertility, Infertility, Female, Infertility, Male
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Rahem Fertility CenterUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 10 Aug 2020 (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.
This is a RCT to test the outcome of two protocols used for preparation of the endometrium for frozen blastocyst embryo transfer
Detailed description
Receptive endometrium and a good quality embryo at the blastocyst developmental stage are prerequisites for a successful implantation to occur. Blastocyst freezing techniques and survival have witnessed huge improvements in the last years. Trials to improve the outcome of frozen embryo transfer (FET) are not to be stopped. The transfer of a good quality blastocyst represents a vital part of the process. Optimization of endometrial receptivity and implantation is an everlasting challenge.
Hormone replacement therapy (HRT) is now proven to be successful for preparation of the endometrium to receive the vitrified warmed embryos. Most HRT protocols give estradiol (E2) first to reach a satisfactory endometrial thickness, then followed by progesterone to mimic the natural cycles. E2 is mostly given for 10 to 14 days and this duration might be prolonged to reach a satisfactory endometrial thickness without adversely affecting the outcome. Trans-vaginal ultrasound assessment of the endometrial thickness before the start of P supplementation has been traditionally used to predict FET cycle outcome. Clinical pregnancy rates (CPR) and live birth rates (LBR) were found to decrease for each millimetre of endometrial thickness below 7 mm. Endometrial thickness however of 9 mm was reported to be among major factors affecting LBR after FET in a large set of data.
Further, there is a recent concept that endometrial compaction (decreased thickness) between the end of estrogen phase and the day of ET has favorable impact on the outcome of FET. Different modalities were proposed to enhance endometrial compaction. One of these modalities was to decrease the dose of estrogen so as to change the estrogen- progesterone ratio as well as help in preventing further endometrial growth.
Aromatase inhibitor (AI) can be used to decrease estrogen before starting P supplementation. Additionally, there were also reports that their use had been associated with improved implantation. It appears interesting to combine the easy scheduled HRT protocol with aromatase inhibitor to maximize FET outcome.
This proposed protocol has not been tested before. In current study, HRT plus AI will be compared with HRT only. In both groups, daily intramuscular P will be given for luteal support as it was shown to give the highest ongoing pregnancy rate in FET cycles.
We did a secondary follow up analysis of some exploratory outcomes (not preregistered). These outcomes were analyzed after publication and they include Live birth rate, implantation rate, hypertensive disorders of pregnancy, large for gestation and congenital anomalies. The results of these outcomes are planned to be presented elsewhere. For openness and transparency, we felt the importance to report this follow up in the registry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRT Plus Aromatase Inhibitor | Experimental | Drug: Estradiol Valerate, Drug: Progesterone, Drug: Aromatase inhibitorHormone replacement treatment (HRT) will be used in all cases. Exogenous estradiol will be started on day 2 or 3 of the cycle. In all participants, 2 mg oral estradiol valerate, will be administered three times daily. Ultrasound evaluation of endometrium will be performed 10 to 12 days after starting E2. Trilaminar endometrium of 9 mm will be the targeted cutoff . If not yet ready, E2 supplementation will be continued with serial US assessment until the desired cutoff is achieved. Thereafter, participants will be randomized to two groups: Group A (HRT plus AI): will be given aromatase inhibitor for 5 days only (2.5 mg twice daily), along with the oral 6 mg E2. Then, daily intramuscular (IM) P in oil (100 mg IM P) will be started in addition to the daily dose of oral 6 mg E2. In both groups, embryos will be warmed on the 6th day of P supplementation. Before undergoing FET, endometrial thickness will be re-evaluated. IM P and 6mg E2 will be continued thereafter. |
| HRT Only | Active comparator | Drug: Estradiol Valerate, Drug: ProgesteroneHormone replacement treatment (HRT) will be used in all cases. Exogenous estradiol will be started on day 2 or 3 of the cycle. In all participants, 2 mg oral estradiol valerate, will be administered three times daily. Ultrasound evaluation of endometrium will be performed 10 to 12 days after starting E2. Trilaminar endometrium of 9 mm will be the targeted cutoff . If not yet ready, E2 supplementation will be continued with serial US assessment until the desired cutoff is achieved. Thereafter, participants will be randomized to two groups Group B (HRT only): will be administered daily intramuscular (IM) P in oil (100 mg IM P) in addition to the daily dose of oral 6 mg E2. In both groups, embryos will be warmed on the 6th day of P supplementation. Before undergoing FET, endometrial thickness will be re-evaluated. IM P and 6mg E2 will be continued thereafter. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged from18 - 37 years old undergoing FET using good quality blastocysts vitrified on day 5(3 BB and more) (according to Gardner and Schoolcraft 1999) (8).
- Participants having at least one good quality blastocyst (3BB and more) available for transfer after warming.
- Participants having trilaminar endometrium of 9 mm after E2 preparation.
Key exclusion criteria (4 listed)
- Women younger than 18 or older than 37 years old.
- Women who have uterine abnormality or pathology.
- Women who will not meet the inclusion criteria.
- Women who will refuse to participate in in the study.
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 |
|---|---|---|
| Estradiol Valerate2mg three times daily | Drug | HRT Only, HRT Plus Aromatase Inhibitor |
| Progesterone100 mg daily intramuscular | Drug | HRT Only, HRT Plus Aromatase Inhibitor |
| Aromatase inhibitor2.5 mg twice daily for 5 days | Drug | HRT Plus Aromatase Inhibitor |
Primary outcome
Ongoing Pregnancy Rate
Time frame: at 12 weeks of gestation
visualization of fetal cardiac pulsation by ultrasound
7 secondary outcomes
endometrial compaction
Time frame: from the end of estradiol phase to the day of embryo transfer up to 11 days
clinical pregnancy rate
Time frame: 6 weeks gestation
Live birth rate
Time frame: 24 weeks
Implantation rate
Time frame: 6 weeks gestation
Number of participants with Hypertensive disorders of pregnancy
Time frame: 20 weeks gestation till postpartum
Number of participants with Large for gestational age
Time frame: from gestation till delivery]
Rate of Congenital anomalies
Time frame: during pregnancy and after birth (one month after birth)
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 27 Apr 2022.
- Background: PubMed 29025055Mackens S, Santos-Ribeiro S, van de Vijver A, Racca A, Van Landuyt L, Tournaye H, Blockeel C. Frozen embryo transfer: a review on the optimal endometrial preparation and timing. Hum Reprod. 2017 Nov 1;32(11):2234-2242. doi: 10.1093/humrep/dex285.
- Background: PubMed 31029432Sekhon L, Feuerstein J, Pan S, Overbey J, Lee JA, Briton-Jones C, Flisser E, Stein DE, Mukherjee T, Grunfeld L, Sandler B, Copperman AB. Endometrial preparation before the transfer of single, vitrified-warmed, euploid blastocysts: does the duration of estradiol treatment influence clinical outcome? Fertil Steril. 2019 Jun;111(6):1177-1185.e3. doi: 10.1016/j.fertnstert.2019.02.024. Epub 2019 Apr 24.
- Background: PubMed 30239738Liu KE, Hartman M, Hartman A, Luo ZC, Mahutte N. The impact of a thin endometrial lining on fresh and frozen-thaw IVF outcomes: an analysis of over 40 000 embryo transfers. Hum Reprod. 2018 Oct 1;33(10):1883-1888. doi: 10.1093/humrep/dey281.
- Background: PubMed 32266278Pan Y, Hao G, Wang Q, Liu H, Wang Z, Jiang Q, Shi Y, Chen ZJ. Major Factors Affecting the Live Birth Rate After Frozen Embryo Transfer Among Young Women. Front Med (Lausanne). 2020 Mar 24;7:94. doi: 10.3389/fmed.2020.00094. eCollection 2020.
- Background: PubMed 31248618Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.
- Background: PubMed 29338855Devine K, Richter KS, Widra EA, McKeeby JL. Vitrified blastocyst transfer cycles with the use of only vaginal progesterone replacement with Endometrin have inferior ongoing pregnancy rates: results from the planned interim analysis of a three-arm randomized controlled noninferiority trial. Fertil Steril. 2018 Feb;109(2):266-275. doi: 10.1016/j.fertnstert.2017.11.004. Epub 2018 Jan 17.
- Background: PubMed 22246449Miller PB, Parnell BA, Bushnell G, Tallman N, Forstein DA, Higdon HL 3rd, Kitawaki J, Lessey BA. Endometrial receptivity defects during IVF cycles with and without letrozole. Hum Reprod. 2012 Mar;27(3):881-8. doi: 10.1093/humrep/der452. Epub 2012 Jan 13.
- Background: PubMed 10369209Gardner DK, Schoolcraft WB. Culture and transfer of human blastocysts. Curr Opin Obstet Gynecol. 1999 Jun;11(3):307-11. doi: 10.1097/00001703-199906000-00013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Estradiol Valerate, Progesterone and Aromatase inhibitor in people with Infertility and Infertility, Female, run by Rahem Fertility Center at 1 site in Egypt.
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 4 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 27 Apr 2022. 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 Egypt. 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?
Ongoing Pregnancy Rate (time frame: at 12 weeks of gestation). 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 NCT04507022, which also lists 8 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 27 Apr 2022.