A Non-interventional Study to Identify the Patients With Severe Luteinizing Hormone Deficiency in the Daily Practice
Pergoveris Non Interventional Study
1 other identifier
observational
3,247
1 country
1
Brief Summary
This non-interventional study is planned to identify the subjects with severe luteinizing hormone (LH) deficiency in the daily practice. The results will be used for the "Periodic Safety Update Report", which is to be regularly sent to the European Medicines Agency (EMEA) and the responsible German Higher Federal Authority (BfArM).
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 2008
Typical duration for all trials
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, 2008
CompletedFirst Submitted
Initial submission to the registry
April 27, 2010
CompletedFirst Posted
Study publicly available on registry
April 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedJuly 16, 2014
April 1, 2011
3.1 years
April 27, 2010
July 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reason for diagnosis of severe LH deficiency
The reasons for the diagnosis of severe LH deficiency could be low endogenous LH, amenorrhea, low endometrial thickness, low estradiol levels.
6 months
Secondary Outcomes (1)
Dose on the first day and the last day of treatment; duration of the stimulation; and the total dose of Pergoveris.
6 months
Eligibility Criteria
Subjects undergoing stimulation with Pergoveris for the ovarian stimulation with intercourse for the optimum (VZO) or with IUI or in preparation for a technology of the assisted conception such as IVF or ICSI.
You may qualify if:
- Female subjects undergoing stimulation with Pergoveris for the ovarian stimulation with VZO or with IUI or in preparation for a technology of the assisted conception such as IVF or ICSI
You may not qualify if:
- Subjects receiving combination cycles with clomifen, follitropin beta, urinary FSH, urinary human menopausal gonadotropin (hMG)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fertility Center Berlin, Spandauer Damm 130
Berlin, 14050, Germany
Related Publications (1)
Buhler K, Naether OG, Bilger W. A large, multicentre, observational, post-marketing surveillance study of the 2:1 formulation of follitropin alfa and lutropin alfa in routine clinical practice for assisted reproductive technology. Reprod Biol Endocrinol. 2014 Jan 14;12:6. doi: 10.1186/1477-7827-12-6.
PMID: 24423045DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sigbert Jahn, PhD
Merck Serono GmbH, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 27, 2010
First Posted
April 28, 2010
Study Start
January 1, 2008
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
July 16, 2014
Record last verified: 2011-04