Efficacy of Luteinizing Hormone (LH) Activity in Low Responder Patients With Transdermal Testosterone
Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study.
1 other identifier
interventional
104
1 country
1
Brief Summary
The investigators have previously demonstrated the utility of transdermal testosterone in in vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate the efficacy of luteinizing hormone (LH) activity added to recombinant follicular stimulating hormone (FSHr) during ovarian stimulation in these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2011
Shorter than P25 for not_applicable
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
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 7, 2011
CompletedFirst Posted
Study publicly available on registry
February 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFebruary 8, 2011
January 1, 2011
5 months
February 7, 2011
February 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ovarian response
number of oocytes obtained per ovarian stimulation cycle
within 2 weeks after begining ovarian stimulation
Secondary Outcomes (3)
clinical pregnancy rate
within 5 weeks (plus or minus 1 week) after embryo transfer
Implantation rate
within 5 weeks (plus/minus 1 week) after embryo transfer
Live birth rate
within 9 months (plus/minus 1 month) after embryo transfer
Study Arms (2)
Testosterone and FSHr
ACTIVE COMPARATORtestosterone and FSHr-LHr
ACTIVE COMPARATORInterventions
75U of LHr added to FSHr ovarian stimulation in IVF, when testosterone was used to improve the ovarian response
FSHr alone used in ovarian stimulation in IVF, when testosterone was used to improve the ovarian response
Eligibility Criteria
You may qualify if:
- Low responder patients: patients with previously canceled cycle or recovery of 3 or less oocytes
You may not qualify if:
- FSH \> 12
- Previous ovarian surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínic
Barcelona, Barcelona, 08036, Spain
Related Publications (2)
Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3.
PMID: 16517559BACKGROUNDFabregues F, Penarrubia J, Creus M, Manau D, Casals G, Carmona F, Balasch J. Transdermal testosterone may improve ovarian response to gonadotrophins in low-responder IVF patients: a randomized, clinical trial. Hum Reprod. 2009 Feb;24(2):349-59. doi: 10.1093/humrep/den428. Epub 2008 Dec 3.
PMID: 19054777RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 7, 2011
First Posted
February 8, 2011
Study Start
January 1, 2011
Primary Completion
June 1, 2011
Study Completion
September 1, 2011
Last Updated
February 8, 2011
Record last verified: 2011-01