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Clinical trial

An Observational Single Center Study to Identify the Relationship Between Serum AMH Dynamics and Early or Normal Ovarian Response to Corifollitropin Alfa (ACO Study)

ID
Name
184/2020
Description
The objective of this study is to evaluate the trend of serum AMH during IVF (in vitro fertilization) cycles, in particular the possible relationship between the dynamics of AMH and the early or normal response to therapies for controlled ovarian stimulation with corifollitropin alfa. The secondary objective is to study the association between the number of follicles equal to or greater than 17 mm on the eighth day of ovarian stimulation and the decline in AMH, and to assess the predictability of the need to add additional therapies after the first week of stimulation ovarian.
Trial arms
Trial start
2020-08-01
Estimated PCD
2023-06-30
Trial end
2023-09-30
Status
Recruiting
Treatment
Corifollitropin alfa
AMH will be measured during ovarian stimulation with corifollitropin alfa
Arms:
Infertile women
Other names:
no other interventions
Size
80
Primary endpoint
Changes in serum Antimullerian Hormone (AMH) levels during ovarian stimulation
AMH will be measured at day 2, day 5, day 8 and the last day (usually day 11) of ovarian stimulation
Eligibility criteria
Inclusion Criteria: * basal serum FSH concentration below 20 UI/L * age between 18 and 46 years * body weight \> 60 kg * use of corifollitrofin alpha for ovarian stimulation. Exclusion criteria: * contraindications to IVF * irregular menstrual cycles
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples'}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-02-08

1 organization

1 product

2 indications

Organization
Azienda Ospedaliero-Universitaria di Modena
Product
Corifollitropin alfa
Indication
infertility
Indication
Woman