Uterine AdenomyosisPhase 4NCT03421639
Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis
A Phase 4 study testing GnRH analog (11.25mg Leuprolide acetate), Aromatase inhibitor and GnRH analog and Aromatase and GnRH analog (11.25mg Leuprolide acetate) in people with Uterine Adenomyosis and Recurrent Implantation Failure, run by Centre for Endocrinology and Reproductive Medicine, Italy at 3 sites in 3 countries.
Trial summary
With this study the investigators want to test which is the best medical treatment for symptomatic adenomyosis affecting women undergoing IVF and with previous implantation failure, between Aromatase inhibitor plus GnRH analog versus GnRH alone, in term pregnancy rate and uterine volume reduction. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Adenomyosis, Recurrent Implantation Failure, Menstrual Pain
- What is being tested?
- GnRH analog (11.25mg Leuprolide acetate), Aromatase inhibitor and GnRH analog and Aromatase and GnRH analog (11.25mg Leuprolide acetate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Dec 2017to 30 Sep 2024
- 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 30 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women with healty conditions
- Adenomyosis
- increased uterine dimensions
- recurrent implantation failure
Who cannot join
- presence of systemic diseases
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Controlled Trial on Adenomyosis Treatment Comparing Aromatase Inhibitor Plus GnRH Analogue Versus GnRH Analog Alone
With this study the investigators want to test which is the best medical treatment for symptomatic adenomyosis affecting women undergoing IVF and with previous implantation failure, between Aromatase inhibitor plus GnRH analog versus GnRH alone, in term pregnancy rate and uterine volume reduction.
Read the detailed description
Recently it has been shown that adenomyosis negatively affects the pregnancy rate in IVF cycles. The investigators used in the past for the treatment of other benign gynecological diseases such as endometriosis and uterine myomas a combined therapy with Aromatase inhibitor plus GnRH analog. With this study the investigators want evaluate which is the best way to treat adenomyosis in order to obtain a higher pregnancy rate in women with symptomatic adenomyosis undergoing IVF who failed a previous IVF attempt. For these reasons the investigators set this controlled trial between GnRH analog plus Aromatase Inhibitor (3.75 mg monthly of Leuprolide plus 1.0mg day of Anastrazole for 3 months) versus an active comparator as GnRH analog alone (3.75 mg monthly of Leuprolide for 3 months) after the treatment patients will undergo embryo transfer of a cryopreserved blastocyst in a previous IVF cycle, and will be followed up for uterine dimension reduction and pain symptom reduction.
- Being tested
- GnRH analog (11.25mg Leuprolide acetate), Aromatase inhibitor and GnRH analog, Aromatase and GnRH analog (11.25mg Leuprolide acetate)
- Keywords
- Implantation failure, Adenomyosis, increased uterine size, IVF, egg donation cycle
- Medical subject headings
- Adenomyosis, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH analog (11.25mg Leuprolide acetate)Drug
Also called Control group
11.25 Leuprolide acetate only one administration
Aromatase inhibitor and GnRH analogDrug
Also called experimental group
1mg/day of Anastrazole for 3 months
Aromatase and GnRH analog (11.25mg Leuprolide acetate)Drug
Also called experimental group
Leuprolide acetate 11.25mg only one
| Study group | Role | What they receive |
|---|---|---|
| GnRH analog alone | Active comparator | control group treated with GnRH analog alone Receives: Drug: GnRH analog (11.25mg Leuprolide acetate) |
| Aromatase inhibitor plus GnRH analog | Experimental | experimental group treated with aromatase inhibitor plus GnRH analog Receives: Drug: Aromatase inhibitor and GnRH analog; Drug: Aromatase and GnRH analog (11.25mg Leuprolide acetate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy after embryo transfer
after treatment patients undergo embryo transfer of a cryopreservad blastocyst
Measured: 12 months
Secondary outcomes (1)
uterine volume reduction
differences in uterine volume pre and post treatment evaluated by ultrasound
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Dec 2017
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine AdenomyosisStudies 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
- Model description
- Randomized controlled trial in two arms study (150 each one)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Endocrinology and Reproductive Medicine, Italy
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- MARCO SBRACIA, MD, Study chair, CERM-HUNGARIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421639
- Sponsor's protocol ID
- CR-01-18
- Status last verified
- Mar 2024
- First submitted
- 30 Jan 2018
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial on Adenomyosis Treatment Comparing Aromatase Inhibitor Plus GnRH Analogue Versus GnRH Analog Alone
- ClinicalTrials.gov ID
- NCT03421639
- Acronym / sponsor ID
- CR-01-18
- Keywords
- Implantation failure, Adenomyosis, increased uterine size, IVF, egg donation cycle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre for Endocrinology and Reproductive Medicine, ItalyResearch network
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 5 Feb 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.
With this study the investigators want to test which is the best medical treatment for symptomatic adenomyosis affecting women undergoing IVF and with previous implantation failure, between Aromatase inhibitor plus GnRH analog versus GnRH alone, in term pregnancy rate and uterine volume reduction.
Detailed description
Recently it has been shown that adenomyosis negatively affects the pregnancy rate in IVF cycles. The investigators used in the past for the treatment of other benign gynecological diseases such as endometriosis and uterine myomas a combined therapy with Aromatase inhibitor plus GnRH analog. With this study the investigators want evaluate which is the best way to treat adenomyosis in order to obtain a higher pregnancy rate in women with symptomatic adenomyosis undergoing IVF who failed a previous IVF attempt. For these reasons the investigators set this controlled trial between GnRH analog plus Aromatase Inhibitor (3.75 mg monthly of Leuprolide plus 1.0mg day of Anastrazole for 3 months) versus an active comparator as GnRH analog alone (3.75 mg monthly of Leuprolide for 3 months) after the treatment patients will undergo embryo transfer of a cryopreserved blastocyst in a previous IVF cycle, and will be followed up for uterine dimension reduction and pain symptom reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized controlled trial in two arms study (150 each one)
| Arm | Type | Receives |
|---|---|---|
| GnRH analog alone | Active comparator | Drug: GnRH analog (11.25mg Leuprolide acetate)control group treated with GnRH analog alone |
| Aromatase inhibitor plus GnRH analog | Experimental | Drug: Aromatase inhibitor and GnRH analog, Drug: Aromatase and GnRH analog (11.25mg Leuprolide acetate)experimental group treated with aromatase inhibitor plus GnRH analog |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women with healty conditions
- Adenomyosis
- increased uterine dimensions
- recurrent implantation failure
Key exclusion criteria (1 listed)
- presence of systemic diseases
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 |
|---|---|---|
| GnRH analog (11.25mg Leuprolide acetate)Also: Control group11.25 Leuprolide acetate only one administration | Drug | GnRH analog alone |
| Aromatase inhibitor and GnRH analogAlso: experimental group1mg/day of Anastrazole for 3 months | Drug | Aromatase inhibitor plus GnRH analog |
| Aromatase and GnRH analog (11.25mg Leuprolide acetate)Also: experimental groupLeuprolide acetate 11.25mg only one | Drug | Aromatase inhibitor plus GnRH analog |
Primary outcome
pregnancy after embryo transfer
Time frame: 12 months
after treatment patients undergo embryo transfer of a cryopreservad blastocyst
1 secondary outcome
uterine volume reduction
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- 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.
MARCO SBRACIA, MD study chair
CERM-HUNGARIA
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GnRH analog (11.25mg Leuprolide acetate), Aromatase inhibitor and GnRH analog and Aromatase and GnRH analog (11.25mg Leuprolide acetate) in people with Uterine Adenomyosis and Recurrent Implantation Failure, run by Centre for Endocrinology and Reproductive Medicine, Italy at 3 sites in 3 countries.
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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Albania, Bulgaria, 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 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?
Results are not available in the source record.
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?
pregnancy after embryo transfer (time frame: 12 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 6 Mar 2024.