Study Stopped
Concerns about safety at the first interim analysis
Metformin in Patients With PCOS and Predictors of Poor Ovarian Response Ongoing In-vitro Fertilization
Effects of Metformin on the Ovarian Response to Gonadotropins for in Vitro Fertilization Treatment in Patients With Polycystic Ovary Syndrome and Predictors of Poor Ovarian Response
1 other identifier
interventional
88
1 country
1
Brief Summary
Metformin should be administered with caution and could be potentially dangerous in infertile patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based ovarian stimulation. However, data that address this point are totally lacking. On the basis of these considerations, the aim of the current clinical trial was to test the hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF cycles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2009
Typical duration for phase_4
1 active site
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, 2009
CompletedFirst Submitted
Initial submission to the registry
May 24, 2010
CompletedFirst Posted
Study publicly available on registry
September 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMay 24, 2011
May 1, 2011
1.7 years
May 24, 2010
May 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of cancellation due to low ovarian response
Number of cancelled cycles/total cycles
one month
Secondary Outcomes (6)
Stimulation length
one month
Gonadotropins dose
one month
Ovulation rate
one month
pregnancy rate
one month
Live-birth rate
nine months
- +1 more secondary outcomes
Study Arms (2)
Metformin
EXPERIMENTALMetformin pre-treatment and co-administration
Placebo
PLACEBO COMPARATORPlacebo pre-treatment and co-administration
Interventions
Eligibility Criteria
You may qualify if:
- PCOS
- Prognosis for poor response
- Infertility
You may not qualify if:
- Male factor infertility
- Tubal infertility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pugliese" Hospital
Catanzaro, Italy, 88100, Italy
Related Publications (1)
Palomba S, Falbo A, Di Cello A, Cappiello F, Tolino A, Zullo F. Does metformin affect the ovarian response to gonadotropins for in vitro fertilization treatment in patients with polycystic ovary syndrome and reduced ovarian reserve? A randomized controlled trial. Fertil Steril. 2011 Nov;96(5):1128-33. doi: 10.1016/j.fertnstert.2011.08.020. Epub 2011 Sep 13.
PMID: 21917254DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fulvio Zullo, MD
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
- PRINCIPAL INVESTIGATOR
Stefano Palomba, MD
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 24, 2010
First Posted
September 24, 2010
Study Start
January 1, 2009
Primary Completion
October 1, 2010
Study Completion
March 1, 2011
Last Updated
May 24, 2011
Record last verified: 2011-05