Retrospective Trial on Low Prognosis Infertile Patients
An Observational Retrospective Cohort Trial on Low Prognosis Infertile Patient's Accessing IVF Cycle Management
1 other identifier
observational
26,883
0 countries
N/A
Brief Summary
The main objective of this study is to analyze management of Controlled Ovarian Stimulation (COS) protocols in low prognosis patients, secondly to observe the clinical outcomes (Fertilization Rate, Pregnancy Rate, the Ongoing Pregnancy Rate and the Live birth Rate) and the total units of gonadotrophins consume per M2 oocyte retrieved in this subgroup.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 19, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedSeptember 25, 2017
September 1, 2017
6 years
September 19, 2017
September 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
induction protocol type
number of antagonist and agonist protocols/ total numbers
6 years
Secondary Outcomes (4)
Fertilization Rate
6 years
Pregnancy Rate
6 years
Ongoing Pregnancy Rate
6 years
Live Birth Rate
6 years
Eligibility Criteria
26,883 consecutive fresh non-donors IVF cycles. Patients who underwent these cycles had consented in writing that their medical records could be used for research purposes, as long as the patients' anonymity was protected and confidentiality of the medical record was assured. Since both of these conditions were met, this study has been approved on March 2th 2017 with an expedited review and approval protocol by the center's Institutional Review Board (IRB). At least 2,000 expected low prognosis patients in the Humanitas Fertility Center Database out of 12,545 cycles performed in the period 2010-2015 with completed pregnancy follow-up.
You may qualify if:
- Age ≤ 44
- Body Mass Index; 18 ≤ BMI ≥ 27
- Number of oocytes retrieved ≤ 9
- Cycles performed between January 2010 - December 2015
You may not qualify if:
- Age \> 44
- Number of oocytes retrieved ≥ 10
- Abnormal uterine cavity
- Endometriosis III-IV stage or adenomyosis
- Testicular spermatozoa PGS (Preimplantation Genetic Screening) cycles
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istituto Clinico Humanitaslead
- Merck Serono International SAcollaborator
Related Publications (1)
Levi-Setti PE, Zerbetto I, Baggiani A, Zannoni E, Sacchi L, Smeraldi A, Morenghi E, De Cesare R, Drovanti A, Santi D. An Observational Retrospective Cohort Trial on 4,828 IVF Cycles Evaluating Different Low Prognosis Patients Following the POSEIDON Criteria. Front Endocrinol (Lausanne). 2019 May 8;10:282. doi: 10.3389/fendo.2019.00282. eCollection 2019.
PMID: 31139146DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2017
First Posted
September 25, 2017
Study Start
January 1, 2010
Primary Completion
December 31, 2015
Study Completion
September 1, 2017
Last Updated
September 25, 2017
Record last verified: 2017-09