Comparison of the Accuracy and Reliability of AMH, FSH and AFC in Predicting Ovarian Response (AMH FSH AFC)
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Blood test
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility focused on measuring in-vitro fertilization, ovarian stimulation
Eligibility Criteria
Inclusion Criteria:
- Age ≤ 45 years at the time of FSH starting
- BMI < 25 kg/m2,
- First IVF attempt
- Receiving GnRH-antagonist protocol
- Had oocyte retrieval
Exclusion Criteria:
- Had ovarian stimulation or ovulation induction within 2 months prior to the study
- PCOS
- Had ovarian tumor or endometrioma
- Hyperprolactinemia
- Thyroid hormone disorders
- Pituitary failure
- Had other medical situations such as liver failure, renal failure, heart disease, diabetes, depression
- Had IVM
Sites / Locations
- An Sinh Hospital
Outcomes
Primary Outcome Measures
Number of oocytes
number of oocytes at time of oocyte retrieval
Secondary Outcome Measures
Full Information
NCT ID
NCT02173444
First Posted
June 23, 2014
Last Updated
June 23, 2014
Sponsor
Vietnam National University
1. Study Identification
Unique Protocol Identification Number
NCT02173444
Brief Title
Comparison of the Accuracy and Reliability of AMH, FSH and AFC in Predicting Ovarian Response
Acronym
AMH FSH AFC
Official Title
Comparison of the Accuracy and Reliability of AMH, FSH and AFC in Predicting Ovarian Response
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vietnam National University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Serum bio-markers have different prediction values for ovarian response during ovarian stimulation in-vitro fertilization
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
in-vitro fertilization, ovarian stimulation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
820 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Blood test
Primary Outcome Measure Information:
Title
Number of oocytes
Time Frame
At the time of oocyte retrieval
Title
number of oocytes at time of oocyte retrieval
Time Frame
up to 14 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≤ 45 years at the time of FSH starting
BMI < 25 kg/m2,
First IVF attempt
Receiving GnRH-antagonist protocol
Had oocyte retrieval
Exclusion Criteria:
Had ovarian stimulation or ovulation induction within 2 months prior to the study
PCOS
Had ovarian tumor or endometrioma
Hyperprolactinemia
Thyroid hormone disorders
Pituitary failure
Had other medical situations such as liver failure, renal failure, heart disease, diabetes, depression
Had IVM
Facility Information:
Facility Name
An Sinh Hospital
City
Ho Chi Minh City
State/Province
Ho Chi Minh
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Accuracy and Reliability of AMH, FSH and AFC in Predicting Ovarian Response
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