Clinical Trial Results:
Efficacy of Dehydroepiandrosterone to overcome the effect of ovarian aging
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Summary
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EudraCT number |
2011-002425-21 |
Trial protocol |
GB |
Global end of trial date |
04 Jan 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Mar 2019
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First version publication date |
01 Mar 2019
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Other versions |
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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 |
11054
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University of Nottingham
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Sponsor organisation address |
University Park, Nottingham, United Kingdom, NG7 2UH
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Public contact |
Bruce Campbell, University of Nottingham, 0044 01158230688, bruce.campbell@nottingham.ac.uk
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Scientific contact |
Bruce Campbell, University of Nottingham, 0044 01158230688, bruce.campbell@nottingham.ac.uk
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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 |
04 Jan 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Nov 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
04 Jan 2016
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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 examine whether supplementation of DHEA for at least twelve weeks prior to and during ovarian stimulation increases the number of oocytes retrieved and the clinical pregnancy rates following IVF/ICSI treatment. • To evaluate the feasibility of conducting a large multicentre randomised controlled trial of DHEA versus Placebo in women affected with ovarian ageing undergoing IVF/ICSI treatment.
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Protection of trial subjects |
Participants were encouraged to report if any side-effects/ issues related to trial medications. They were given relevant contact details.
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Background therapy |
IVF treatment | ||
Evidence for comparator |
Placebo with inactive ingredients used | ||
Actual start date of recruitment |
01 May 2012
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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 |
United Kingdom: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
60
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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) |
60
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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 |
Age stratified randomisation was performed by computer-based random permuted block randomisation, created by the University of Nottingham Clinical Trials Unit (CTU). They were randomised to receive either capsules of 75 mg DHEA or placebo taken orally once daily for at least 12 weeks before and during controlled ovarian stimulation until the day be | |||||||||
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Pre-assignment
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Screening details |
Women aged more than 23 years, who were predicted to have diminished ovarian reserved determined by antral follicle count scan less than 10 and/or serum Anti-Mullerian hormone less than 5 pmol/L undertaking either IVF or ICSI treatment at the clinic, were asked to participate in the study at the time of their initial consultation. Patients had to h | |||||||||
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Period 1
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Period 1 title |
Baseline period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Assessor | |||||||||
Blinding implementation details |
Participants were issued their trial number as well as randomisation number and were issued their corresponding IMPs supply from the unblinded pharmacist according to the randomisation. They were randomised to receive either capsules of 75 mg DHEA or placebo, which looks exactly similar to the study medication
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Study | |||||||||
Arm description |
Those who received capsules of 75 mg DHEA | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
DHEA
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Investigational medicinal product code |
35929
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
75 mg once daily
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Arm title
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control | |||||||||
Arm description |
received placebo | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
one capsule daily
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: A few subjects did not start treatment due to personal reasons/ pregnancy |
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Baseline characteristics reporting groups
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Reporting group title |
Study
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Reporting group description |
Those who received capsules of 75 mg DHEA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
control
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Reporting group description |
received placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Study
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Reporting group description |
Those who received capsules of 75 mg DHEA | ||
Reporting group title |
control
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Reporting group description |
received placebo | ||
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End point title |
Live birth | |||||||||
End point description |
number of Live born babies after IVF treatment
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End point type |
Primary
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End point timeframe |
Nine months
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Statistical analysis title |
Relative risk | |||||||||
Statistical analysis description |
Differences in proportional outcome analysed using relative risk
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Comparison groups |
Study v control
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Number of subjects included in analysis |
52
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.63 [1] | |||||||||
Method |
Chi-squared corrected | |||||||||
Parameter type |
Risk ratio (RR) | |||||||||
Point estimate |
0.74
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.22 | |||||||||
upper limit |
2.48 | |||||||||
| Notes [1] - not significant |
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Adverse events information [1]
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Timeframe for reporting adverse events |
during treatment and unto 9 months after
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Assessment type |
Systematic | ||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
study and control
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Reporting group description |
Whole study population | ||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: the adverse events reported are directly related to IVF treatment rather than due to trial medication or placebo |
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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. | |||
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Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/28934714 |
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