The Relationship Between Serum AMH Dynamics and Early or Normal Ovarian Response to Corifollitropin Alfa
ACO
An Observational Single Center Study to Identify the Relationship Between Serum AMH Dynamics and Early or Normal Ovarian Response to Corifollitropin Alfa (ACO Study)
1 other identifier
observational
80
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2020
CompletedFirst Posted
Study publicly available on registry
July 23, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedFebruary 8, 2023
February 1, 2023
2.9 years
July 3, 2020
February 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in serum Antimullerian Hormone (AMH) levels during ovarian stimulation
Serum concentrations of AMH will be measured during ovarian stimulation with corifollitropin alfa.
AMH will be measured at day 2, day 5, day 8 and the last day (usually day 11) of ovarian stimulation
Study Arms (1)
Infertile women
the group consists of 80 infertile patients undergoing IVF
Interventions
AMH will be measured during ovarian stimulation with corifollitropin alfa
Eligibility Criteria
Infertile patients
You may qualify if:
- 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.
You may not qualify if:
- contraindications to IVF
- irregular menstrual cycles
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico di Modena
Modena, Modena - MO, 41123, Italy
Biospecimen
blood samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio La Marca
University of Modena and Reggio Emilia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 3, 2020
First Posted
July 23, 2020
Study Start
August 1, 2020
Primary Completion
June 30, 2023
Study Completion
September 30, 2023
Last Updated
February 8, 2023
Record last verified: 2023-02