Clinical trial
A Controlled Trial on Adenomyosis Treatment Comparing Aromatase Inhibitor Plus GnRH Analogue Versus GnRH Analog Alone
Name
CR-01-18
Description
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.
Trial arms
Trial start
2017-12-01
Estimated PCD
2024-09-30
Trial end
2024-09-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
GnRH analog (11.25mg Leuprolide acetate)
11.25 Leuprolide acetate only one administration
Arms:
GnRH analog alone
Other names:
Control group
Aromatase inhibitor and GnRH analog
1mg/day of Anastrazole for 3 months
Arms:
Aromatase inhibitor plus GnRH analog
Other names:
experimental group
Aromatase and GnRH analog (11.25mg Leuprolide acetate)
Leuprolide acetate 11.25mg only one
Arms:
Aromatase inhibitor plus GnRH analog
Other names:
experimental group
Size
300
Primary endpoint
pregnancy after embryo transfer
12 months
Eligibility criteria
Inclusion Criteria:
* women with healty conditions
* Adenomyosis
* increased uterine dimensions
* recurrent implantation failure
Exclusion Criteria:
* presence of systemic diseases
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial in two arms study (150 each one)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Patients will take similar kind medications by an indipendent person', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2024-03-06
1 organization
3 products
3 indications
Product
GnRH analogIndication
AdenomyosisIndication
Recurrent Implantation FailureIndication
DysmenorrheaProduct
Aromatase and GnRH analog