Individualization of Ovarian Stimulation Using AMH Maximizes the Benefits and Minimizes Complications and Risks
Individualization of Controlled Ovarian Stimulation Using Anti-mullerian Hormone as a Biomarker of Ovarian Response Maximizes the Beneficial Effects of Treatment and Minimizes Complications and Risks.
1 other identifier
interventional
250
1 country
1
Brief Summary
The purpose oh the study is to determine the usefulness of anti-Mullerian hormone (AMH) to identify women at risk of excessive and poor response in controlled ovarian stimulation (COS) for in vitro fertilization (IVF), and the clinical impact of applying individualized COS strategies in these subsets of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
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
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 24, 2013
CompletedFirst Posted
Study publicly available on registry
June 27, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJune 26, 2014
June 1, 2014
1.3 years
June 24, 2013
June 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of oocytes retrieved
number of oocyte retrieved classified as: poor response: ≤4 oocytes normal response: 5 - 19 oocytes excessive response: ≥20 oocytes
1 day (on the day of oocyte retrieval)
Secondary Outcomes (3)
clinical pregnancy rate
4 weeks after embryo transfer
occurrence of ovarian hyperstimulation syndrome
4 weeks after embryo transfer
cancellation
on the 8th day of ovarian stimulation
Study Arms (2)
conventional ovarian stimulation
ACTIVE COMPARATORwomen whose protocol of ovarian stimulation was based on age, ovarian size and previous treatment
individualized ovarian stimulation
ACTIVE COMPARATORwomen whose protocol of ovarian stimulation was based on anti-mullerian hormone
Interventions
a protocol of ovarian stimulation with recombinant FSH with dose according to age, ovarian size and previous treatment. In patients alder than 35, recombinant LH was added to ovarian stimulation.
After defining cut-off points of anti-mullerian hormone, using a ROC analysis, to discriminate excessive (≥20 oocytes retrieved) and poor response (≤4 oocytes retrieved), a individualized protocol was defined.Mild stimulation using daily doses (112.5 to 150 IU) of recombinant FSH or recombinant FSH combined with recombinant LH supplementation (375 IU total daily dose) were given to patients identified as at risk of excessive and poor response.
Eligibility Criteria
You may qualify if:
- women with in vitro fertilization treatment indication
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Androfert
Campinas, São Paulo, 13075-460, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rogerio BF Leao, MD
ANDROFERT - Clinica de Andrologia e Reproducao Humana
- STUDY DIRECTOR
Sandro C Esteves, PhD
ANDROFERT - Clinica de Andrologia e Reproducao Humana
- STUDY CHAIR
Fabiana Y Nakano
ANDROFERT - Clinica de Andrologia e Reproducao Humana
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2013
First Posted
June 27, 2013
Study Start
March 1, 2012
Primary Completion
June 1, 2013
Study Completion
July 1, 2013
Last Updated
June 26, 2014
Record last verified: 2014-06