InfertilityPhase 2RISENCT07153367
Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)
A Phase 2 study testing REKOVELLE (Follitropin Delta) in people with Infertility and Insemination, run by Centre Hospitalier Intercommunal Creteil at 5 sites in France.
Trial summary
The aim of this study is to evaluate the use of a fixed dose of 3.66 mcg of follitropin delta (Rekovelle) on ovarian response during ovarian stimulation for intrauterine insemination (IUI). The assumption is that this fixed dose will be effective while minimizing the risk of multiple pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility, Insemination
- What is being tested?
- REKOVELLE (Follitropin Delta)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesFrance
- Study dates
- 17 Dec 2025to 17 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Normo-ovulatory patients
- 18 - 38 included years old
- BMI between 18 and 29 included kg/m²
- Regular menstrual cycles
- At least one healthy Fallopian tube
- Normal uterus cavity
- First treatment for IUI
- Affiliation to the social security
Who cannot join
- Endometriosis Stage III
- Total mobile sperm count <1 million
- Severe spermatogenesis disorders
- Women with Poly Cystic Ovary Syndrom
- History of OHSS or excessive response to gonadotrophins
- Chronic disease with contraindication to ovarian stimulation with gonadotrophins
Show all 32Show fewer
- Known genetic disease
- Hypothalamus or pituitary tumors
- Ovarian hypertrophy or ovarian cyst not due to polycystic ovary syndrome
- Gynecological bleeding of unknown etiology
- Ovarian, uterine or breast carcinoma
- Primary ovarian failure
- Genital malformations incompatible with pregnancy
- Uterine fibroids incompatible with pregnancy
- Protected persons (pregnant women, nursing mothers, person under guardianship, minors, persons deprived of liberty, and persons unable to give consent)
- Tumors (including meningioma) whose development is known or suspected to be progesterone-dependent
- History of hepatic dysfunction
- Have been receiving progestogen therapy for more than 6 months
- Known contraindication to hormonal treatments (progestogens or oestrogens), or with a history of adverse events related to their use
- Previous thromboembolism events during or following the use of gonadotrophins or with high risk factors for thromboembolic events (venous or arterial)
- Previous or current treatment with gonadotrophins
- Hypersensitivity to the active substance or to any of the excipients
- High risk of OHSS such as women with AMH ≥ 35 pmol/L
- History of severe uterine malformation (unicornuate or bicornuate uterus),
- Past history of ovarian torsion
- Uncontrolled thyroid dysfunction
- Uncontrolled adrenal dysfunction
- Hydrosalpynx
- Breast pathologies not compatible with gonadotrophin stimulation
- Use of infertility medications that could affect follicle stimulation and maturation such as GH
- Participation in other interventional research
- Not able to understand and sign the written informed consent form
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 4 recruiting
- Recruiting
Cabinet Dr Elodie Descat-Polyclinique Jean Villar
Bruges, 33520
Elodie Descat, Dr, elodie.descat@gmail.com
Elodie Descat, Dr
- Recruiting
Chi Creteil
Créteil, 94000
Maud Pasquier, Dr, 0033 1 57 02 24 70, Maud.Pasquier@chicreteil.fr
Maud Pasquier, Dr
- Recruiting
Cabinet Dr Géraldine PORCU-Institut de Médecine de la Reproduction
Marseille, 13008
Géraldine Porcu-Buisson, Dr, geraldine.porcu-buisson@hotmail.fr
Géraldine Porcu-Buisson, Dr
- Recruiting
Cabinet Dr Nicolas Chevalier-Centre AMP Saint Roch
Montpellier, 34070
Nicolas Chevalier, Dr, nicolas.chevalier.doc@hotmail.fr
Nicolas Chevalier, Dr
- Suspended
Cabinet Dr Nathalie Massin- Hôpital Américain De Paris
Neuilly-sur-Seine, 92200
About this study
The aim of this study is to evaluate the use of a fixed dose of 3.66 mcg of follitropin delta (Rekovelle) on ovarian response during ovarian stimulation for intrauterine insemination (IUI). The assumption is that this fixed dose will be effective while minimizing the risk of multiple pregnancies. A recent study demonstrated the efficacy of follitropin delta for ovarian stimulation in IUI, and it has been approved in France for controlled ovarian stimulation in assisted reproductive techniques such as in vitro fertilization (IVF) and IVF with intracytoplasmic sperm injection (ICSI). With an adapted dose of Rekovelle for patients with regular menstrual cycles, ovarian stimulation is optimized from the first attempt, promoting the development of two follicles to improve pregnancy chances while reducing the risk of multiple pregnancies. This approach aims to achieve pregnancy faster and provide a more comfortable treatment experience.
Read the detailed description
Intrauterine insemination (IUI) is a frequently used step in the management of unexplained infertility or mild fertility disorders. In normal-weight patients, the main objective of ovarian stimulation in IUI is to obtain a controlled ovarian response, ideally bifollicular.
Moreover, the main risks currently associated with IUI are multiple pregnancies and iatrogenic complications (cycle cancellation due to insufficient response or excessive response to stimulation more than 3 follicles). It is therefore essential to optimize stimulation treatment protocols to ensure IUI under the best possible conditions.
Due to a precise dose adjustment with Follitropin Delta, the product used in the study (REKOVELLE), for normo-ovulatory patient, an optimal response (bifollicular response) is expected for the majority of patients from the first stimulation. This goal will also facilitate quicker pregnancy attainment and reduce the risk of drop-out and insémination annulation The hypothesis is that this dosage would be efficient and also minimize the risk of multiple pregnancies During the screening visit, the investigator checks the patient's eligibility and informs her about the RISE study. At the inclusion visit, written informed consent is obtained, and the Rekovelle® treatment is explained and initiated. Monitoring visits start on day 9 and then every 2 days until two mature follicles develop. Ovocyte maturation is triggered with an hCG injection, followed by insemination 24 to 36 hours later, performed according to routine care. Follow-up visits occur at 6-8 weeks and 13 weeks post-insemination.
- Conditions
- Infertility, Insemination
- Being tested
- REKOVELLE (Follitropin Delta)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REKOVELLE (Follitropin Delta)Drug
Each patient will start the ovarian stimulation with a fixed dose of 3,66 mcg of Rekovelle ® on day 4 of the natural cycle (Stimulation day 1-S1). The stimulation period will last a maximum of 13 days.
Patients will be regularly evaluated to monitor the response to stimulation with ultrasound scan and blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Rekovelle Arm | Experimental | Not described Receives: Drug: REKOVELLE (Follitropin Delta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm.
Measured: up to 9 months
Secondary outcomes (37)
Number of follicles ≥14 mm on the day of trigger
Number of follicles ≥14 mm on the day of trigger ( by cycle)
Measured: Up to Day 15 of the cycle (each cycle is 28 days)
Number of follicles between 10 et 13 mm on the day of trigger
Number of follicles between 10 et 13 mm on the day of trigger (by cycle)
Measured: Up to Day 15 of the cycle (each cycle is 28 days)
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm for each cycle and according to dose adjustment
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm for each cycle and according to dose adjustment
Measured: up to 9 months
Presence or absence of dose adjustment in subsequent cycles
Presence or absence of dose adjustment in subsequent cycles
Measured: up to 9 months
E2 level on the day of trigger
E2 level on the day of trigger (pg/ml)
Measured: Up to Day 15 of the cycle (each cycle is 28 days)
Dose adjustment on subsequent cycle(s) : quantity of mcg
Dose adjustment on subsequent cycle(s) : quantity of mcg
Measured: up to 9 months
PG level on the day of trigger
PG level on the day of trigger (ng/ml)
Measured: Up to Day 15 of the cycle (each cycle is 28 days)
LH level on the day of trigger
LH level on the day of trigger (UI/L)
Measured: Up to Day 15 of the cycle (each cycle is 28 days)
Frequency of spontaneous LH surge by cycle , at the end of stimulation
Frequency of spontaneous LH surge by cycle , at the end of stimulation (last day of stimulation)
Measured: up to 9 months
Cycle cancellation rate
Cycle cancellation rate (by cycle) . The Cycle is cancelled when more than 2 follicles ≥ 14mm or 4 follicles ≥ 10mm, or if there is no response to treatment.
Measured: up to 9 months
Pregnancy loss rate
Pregnancy loss rate
Measured: up to 9 months
Rate of Biochemical pregnancy (βhCG test) by initiated cycle
Rate of Biochemical pregnancy (βhCG test) by initiated cycle
Measured: From enrollment to 2 weeks after IUI
Rate of Clinical pregnancy by initiated cycle
Rate of Clinical pregnancy by initiated cycle
Measured: From enrollment to 8 weeks after IUI
Rate of Ongoing pregnancy by initiated cycle
Rate of Ongoing pregnancy by initiated cycle
Measured: From enrollment to 13 weeks after IUI
Pregnancy rate with one follicle or two follicles diameter ≥14 mm
Pregnancy rate with one follicle or two follicles diameter ≥14 mm
Measured: up to 9 months
Multiple pregnancy rate
Multiple pregnancy rate
Measured: up to 9 months
Time to pregnancy
Time to pregnancy (time between 1st stimulation and date of pregnancy)
Measured: From first stimulation until pregnancy confirmed by HCG > 100 UI/L, assessed up to 6 months.
The number of stimulation days.
The number of stimulation days.
Measured: up to 9 months
Unexpected and related Events
Unexpected and related Events
Measured: up to 9 months
Duration in days between each cycle
Duration in days between each cycle
Measured: up to 9 months
Dose adjustment on subsequent cycle(s) : number of cycles
Dose adjustment on subsequent cycle(s) : number of cycles
Measured: up to 9 months
Dose adjustment on subsequent cycle(s) : percentage of cycles
Dose adjustment on subsequent cycle(s) : percentage of cycles
Measured: up to 9 months
Rate of Biochemical pregnancy (βhCG test) by insemination
Rate of Biochemical pregnancy (βhCG test) by insemination
Measured: From enrollment to 2 weeks after IUI
Rate of Biochemical pregnancy (βhCG test):cumulative rates
Rate of Biochemical pregnancy (βhCG test) : cumulative rates
Measured: From enrollment to 2 weeks after IUI
Rate of Clinical pregnancy by insemination
Rate of Clinical pregnancy by insemination
Measured: From enrollment to 8 weeks after IUI
Rate of Clinical pregnancy (cumulative rates)
Rate of Clinical pregnancy (cumulative rates)
Measured: From enrollment to 8 weeks after IUI
Rate of Ongoing pregnancy by insemination
Rate of Ongoing pregnancy by insemination
Measured: From enrollment to 13 weeks after IUI
Rate of Ongoing pregnancy: cumulative rates
Rate of Ongoing pregnancy: cumulative rates
Measured: From enrollment to 13 weeks after IUI
The duration of stimulation for each cycle
The duration of stimulation for each cycle
Measured: up to 9 months
Endometrial thickness
Endometrial thickness
Measured: up to 9 months
Pregnancy outcome according to the cycle rank
Pregnancy outcome according to the cycle rank
Measured: up to 9 months
Cumulative pregnancy outcome up to 3 cycles
Cumulative pregnancy outcome up to 3 cycles
Measured: up to 9 months
Number of OHSS
Number of OHSS
Measured: up to 9 months
Number of ectopic pregnancy
Number of ectopic pregnancy
Measured: up tp 9 months
Number of ovarian torsion
Number of ovarian torsion
Measured: up to 9 months
Number of thromboembolic events
Number of thromboembolic events
Measured: up to 9 months
Causes of cycle cancellation
Causes of cycle cancellation
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start17 Dec 2025
- Primary completion17 Dec 2027 (estimated)
- Study completion17 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Nicolas Chevalier, Principal investigator, Centre AMP Saint Roch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153367
- Sponsor's protocol ID
- RISE
- Acronym
- RISE
- Status last verified
- Dec 2025
- First submitted
- 3 Jul 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)
- ClinicalTrials.gov ID
- NCT07153367
- Acronym / sponsor ID
- RISE / RISE
- Conditions
- Infertility, Insemination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 17 Dec 2027 (estimated)
- Study completion
- 17 Mar 2028 (estimated)
- First posted
- 4 Sep 2025 (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 aim of this study is to evaluate the use of a fixed dose of 3.66 mcg of follitropin delta (Rekovelle) on ovarian response during ovarian stimulation for intrauterine insemination (IUI). The assumption is that this fixed dose will be effective while minimizing the risk of multiple pregnancies. A recent study demonstrated the efficacy of follitropin delta for ovarian stimulation in IUI, and it has been approved in France for controlled ovarian stimulation in assisted reproductive techniques such as in vitro fertilization (IVF) and IVF with intracytoplasmic sperm injection (ICSI). With an adapted dose of Rekovelle for patients with regular menstrual cycles, ovarian stimulation is optimized from the first attempt, promoting the development of two follicles to improve pregnancy chances while reducing the risk of multiple pregnancies. This approach aims to achieve pregnancy faster and provide a more comfortable treatment experience.
Detailed description
Intrauterine insemination (IUI) is a frequently used step in the management of unexplained infertility or mild fertility disorders. In normal-weight patients, the main objective of ovarian stimulation in IUI is to obtain a controlled ovarian response, ideally bifollicular.
Moreover, the main risks currently associated with IUI are multiple pregnancies and iatrogenic complications (cycle cancellation due to insufficient response or excessive response to stimulation more than 3 follicles). It is therefore essential to optimize stimulation treatment protocols to ensure IUI under the best possible conditions.
Due to a precise dose adjustment with Follitropin Delta, the product used in the study (REKOVELLE), for normo-ovulatory patient, an optimal response (bifollicular response) is expected for the majority of patients from the first stimulation. This goal will also facilitate quicker pregnancy attainment and reduce the risk of drop-out and insémination annulation The hypothesis is that this dosage would be efficient and also minimize the risk of multiple pregnancies During the screening visit, the investigator checks the patient's eligibility and informs her about the RISE study. At the inclusion visit, written informed consent is obtained, and the Rekovelle® treatment is explained and initiated. Monitoring visits start on day 9 and then every 2 days until two mature follicles develop. Ovocyte maturation is triggered with an hCG injection, followed by insemination 24 to 36 hours later, performed according to routine care. Follow-up visits occur at 6-8 weeks and 13 weeks post-insemination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rekovelle Arm | Experimental | Drug: REKOVELLE (Follitropin Delta) |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Normo-ovulatory patients
- 18 - 38 included years old
- BMI between 18 and 29 included kg/m²
- Regular menstrual cycles
- At least one healthy Fallopian tube
Key exclusion criteria (32 listed)
- Endometriosis Stage III
- Total mobile sperm count <1 million
- Severe spermatogenesis disorders
- Women with Poly Cystic Ovary Syndrom
- History of OHSS or excessive response to gonadotrophins
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 |
|---|---|---|
| REKOVELLE (Follitropin Delta)Each patient will start the ovarian stimulation with a fixed dose of 3,66 mcg of Rekovelle ® on day 4 of the natural cycle (Stimulation day 1-S1). The stimulation period will last a maximum of 13 days. Patients will be regularly evaluated to monitor the response to stimulation with ultrasound scan and blood sampling | Drug | Rekovelle Arm |
Primary outcome
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation
Time frame: up to 9 months
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm.
37 secondary outcomes
Number of follicles ≥14 mm on the day of trigger
Time frame: Up to Day 15 of the cycle (each cycle is 28 days)
Number of follicles between 10 et 13 mm on the day of trigger
Time frame: Up to Day 15 of the cycle (each cycle is 28 days)
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm for each cycle and according to dose adjustment
Time frame: up to 9 months
Presence or absence of dose adjustment in subsequent cycles
Time frame: up to 9 months
E2 level on the day of trigger
Time frame: Up to Day 15 of the cycle (each cycle is 28 days)
Dose adjustment on subsequent cycle(s) : quantity of mcg
Time frame: up to 9 months
PG level on the day of trigger
Time frame: Up to Day 15 of the cycle (each cycle is 28 days)
LH level on the day of trigger
Time frame: Up to Day 15 of the cycle (each cycle is 28 days)
Frequency of spontaneous LH surge by cycle , at the end of stimulation
Time frame: up to 9 months
Cycle cancellation rate
Time frame: up to 9 months
Pregnancy loss rate
Time frame: up to 9 months
Rate of Biochemical pregnancy (βhCG test) by initiated cycle
Time frame: From enrollment to 2 weeks after IUI
Rate of Clinical pregnancy by initiated cycle
Time frame: From enrollment to 8 weeks after IUI
Rate of Ongoing pregnancy by initiated cycle
Time frame: From enrollment to 13 weeks after IUI
Pregnancy rate with one follicle or two follicles diameter ≥14 mm
Time frame: up to 9 months
Multiple pregnancy rate
Time frame: up to 9 months
Time to pregnancy
Time frame: From first stimulation until pregnancy confirmed by HCG > 100 UI/L, assessed up to 6 months.
The number of stimulation days.
Time frame: up to 9 months
Unexpected and related Events
Time frame: up to 9 months
Duration in days between each cycle
Time frame: up to 9 months
Dose adjustment on subsequent cycle(s) : number of cycles
Time frame: up to 9 months
Dose adjustment on subsequent cycle(s) : percentage of cycles
Time frame: up to 9 months
Rate of Biochemical pregnancy (βhCG test) by insemination
Time frame: From enrollment to 2 weeks after IUI
Rate of Biochemical pregnancy (βhCG test):cumulative rates
Time frame: From enrollment to 2 weeks after IUI
Rate of Clinical pregnancy by insemination
Time frame: From enrollment to 8 weeks after IUI
Rate of Clinical pregnancy (cumulative rates)
Time frame: From enrollment to 8 weeks after IUI
Rate of Ongoing pregnancy by insemination
Time frame: From enrollment to 13 weeks after IUI
Rate of Ongoing pregnancy: cumulative rates
Time frame: From enrollment to 13 weeks after IUI
The duration of stimulation for each cycle
Time frame: up to 9 months
Endometrial thickness
Time frame: up to 9 months
Pregnancy outcome according to the cycle rank
Time frame: up to 9 months
Cumulative pregnancy outcome up to 3 cycles
Time frame: up to 9 months
Number of OHSS
Time frame: up to 9 months
Number of ectopic pregnancy
Time frame: up tp 9 months
Number of ovarian torsion
Time frame: up to 9 months
Number of thromboembolic events
Time frame: up to 9 months
Causes of cycle cancellation
Time frame: up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- 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.
Nicolas Chevalier principal investigator
Centre AMP Saint Roch
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REKOVELLE (Follitropin Delta) in people with Infertility and Insemination, run by Centre Hospitalier Intercommunal Creteil at 5 sites 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 8 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aroua Ben Guirat (+33157023710, aroua.benguirat@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (time frame: up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2026.