Clinical trial
Continuous Ovarian Stimulation in DUOSTIM Cycles.
Name
IBMR31
Description
To evaluate the efficacy of the weekly use of corifollitropin alfa in double ovarian stimulation process and to compare it to the conventional protocol with daily medication administration.
Trial arms
Trial start
2022-11-17
Estimated PCD
2023-04-30
Trial end
2023-05-30
Status
Recruiting
Phase
Early phase I
Treatment
Corifollitropin Alfa
150 micrograms per dose
Arms:
Study group
Other names:
4 Weekly Corifollitropin Alfa injections
Follitropin Alfa
Variable dose.
Arms:
Control group
Other names:
Daily injections of gonadotropins
Follitropin Alfa Biosimilar
Variable dose.
Arms:
Control group
Other names:
Daily injections of gonadotropins
Urinary Human follicle stimulating hormone
Variable dose.
Arms:
Control group
Other names:
Daily injections of gonadotropins
Size
30
Primary endpoint
number of retrieved oocytes - study group
Through study completion, an average of four months
number of retrieved oocytes - comparison
Through study completion, an average of four months
Eligibility criteria
Inclusion Criteria:
* Patients with indication for DUOSTIM protocol
* Maximum age of 43 years (up to one day before their 44th birthday) at the beginning of the stimulation process.
* Ability to participate and comply with the study protocol.
* To have given written consent
Exclusion Criteria:
* Finding of ovarian pathology at the time of initiation of stimulation: e.g. ovarian cysts.
* Concurrent participation in another study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-04-18
1 organization
4 products
1 indication
Organization
Instituto BernabeuProduct
Corifollitropin AlfaIndication
InfertilityProduct
Follitropin AlfaProduct
Follitropin Alfa Biosimilar