Clinical Trial Results:
An AMH based indivdualised controlled ovarian stimulation regiment using
Corifollitrophin or graded doses of rFSH versus a standard protocol. A
randomised controlled trial
Summary
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EudraCT number |
2012-004969-40 |
Trial protocol |
DK |
Global end of trial date |
10 Jan 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Sep 2021
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First version publication date |
17 Sep 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
RHFERAMH-0001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Rigshospitalet
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Sponsor organisation address |
Blegdamsvej, Copenhagen, Denmark, 2100
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Public contact |
Professor Anders Nyboe Andersen, Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, +45 35451315, anders.nyboe.andersen@regionh.dk
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Scientific contact |
Professor Anders Nyboe Andersen, Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, +45 35451315, anders.nyboe.andersen@regionh.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Sep 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Nov 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Jan 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To show that the group randomized to individual AMH based stimulation
achieves a more homogeneous distribution of the retrieved eggs than
the group receiving standard treatment.
Primary endpoint:
The primary endpoint is an appropriate or an inappropriate number of
oocytes:
This should be understood in the term of patients in the two arms are
classified as having an appropriate response (5 - 14 eggs) or
inappropriate response (<5 or> 14 eggs);
An inappropriate response includes those patients where the treatment
is canceled due to either too few follicles or egg maturation with hCG
omitted due to risk of OHSS (given as GnRH agonist (Suprefact) instead
of)
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Protection of trial subjects |
None besides regular good clinical practice
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Jan 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 221
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Worldwide total number of subjects |
221
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EEA total number of subjects |
221
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
221
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
Clinical interview | |||||||||
Period 1
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Period 1 title |
Recruitment (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention | |||||||||
Arm description |
Individualized FSH dosing | |||||||||
Arm type |
Individualized dosing | |||||||||
Investigational medicinal product name |
Puregon
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for suspension for injection
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Routes of administration |
Injection
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Dosage and administration details |
As usually adm. inf fertility treatment
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Arm title
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Standard dosing | |||||||||
Arm description |
Standard FSH dosing | |||||||||
Arm type |
Normal dosing | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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End points reporting groups
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Reporting group title |
Intervention
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Reporting group description |
Individualized FSH dosing | ||
Reporting group title |
Standard dosing
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Reporting group description |
Standard FSH dosing |
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End point title |
Intended number of oocytes retrieved | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
November 2017
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Statistical analysis title |
Proportion of patients to reach intended target | |||||||||
Comparison groups |
Standard dosing v Intervention
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Number of subjects included in analysis |
221
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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Notes [1] - basic calculations |
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Adverse events information
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Timeframe for reporting adverse events |
February 2013 to November 2018
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Assessment type |
Non-systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
unknown
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Reporting groups
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Reporting group title |
Minor
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Reporting group description |
- | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 4% | |||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |