Clinical Trial Results:
Optimizing serum progesterone level during luteal phase in hormone replacement therapy frozen embryo transfer (HRT-FET) cycle – interventional and observational trial
Summary
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EudraCT number |
2019-001539-29 |
Trial protocol |
DK |
Global end of trial date |
20 Dec 2022
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Results information
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Results version number |
v2(current) |
This version publication date |
24 Aug 2024
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First version publication date |
07 Sep 2023
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Other versions |
v1 |
Version creation reason |
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Summary report(s) |
End of study report |
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 |
alsbjerg1
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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 |
The Fertility Clinic, Skive Regional Hospital
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Sponsor organisation address |
Resenvej 25, Skive, Denmark, 7800
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Public contact |
The Fertility Clinic, Skive Regiona, The Fertility Clinic, Skive Regional Hospital, +45 78445760, birgit.alsbjerg@midt.rm.dk
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Scientific contact |
The Fertility Clinic, Skive Regiona, The Fertility Clinic, Skive Regional Hospital, +45 78445760, birgit.alsbjerg@midt.rm.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 |
20 Mar 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Dec 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Dec 2022
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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 |
The aim of this study is to investigate the effect of adding progesterone rectally in hormone replacement treatment frozen embryo transfer (HRT-FET) cycles if the serum progesterone (P4) is <35nmol/l on embryo transfer day.
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Protection of trial subjects |
The study was approved by the scientific Ethics Committee of the Central Denmark Region – Project number: M-2019-200-19
Written informed consent was obtained from all participants prior to inclusion
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Jan 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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: 488
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Worldwide total number of subjects |
488
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EEA total number of subjects |
488
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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) |
488
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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 |
The first patient was enrolled in January 2020 and the last patient was enrolled in September 2022 | |||||||||
Pre-assignment
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Screening details |
A total of 607 patients were assessed for eligibility and 488 patients were subsequently recruited. No patient was lost to follow-up | |||||||||
Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-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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Group <35 nmol/l | |||||||||
Arm description |
HRT treatment including 6 mg estradiol (Estrofem) and vaginally progesterone (Cyclogest) 400 mg twice a day. If serum P4 is <35 nmol/l at the day of embryo transfer the progesterone regime is changed to 400 mg vaginally Cyclogest and additional 400 mg Cyclogest administered rectally starting at the day of transfer. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Cyclogest
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suppository
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Routes of administration |
Rectal use
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Dosage and administration details |
(400mg/12hour starting that same day as embryo transfer. In pregnant patients, rectal administration continued until week 8 of gestation.
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Arm title
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Group >35 nmol/l | |||||||||
Arm description |
HRT treatment including 6 mg estradiol (Estrofem) and vaginally progesterone (Cyclogest) 400 mg twice a day | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Group <35 nmol/l
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Reporting group description |
HRT treatment including 6 mg estradiol (Estrofem) and vaginally progesterone (Cyclogest) 400 mg twice a day. If serum P4 is <35 nmol/l at the day of embryo transfer the progesterone regime is changed to 400 mg vaginally Cyclogest and additional 400 mg Cyclogest administered rectally starting at the day of transfer. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group >35 nmol/l
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Reporting group description |
HRT treatment including 6 mg estradiol (Estrofem) and vaginally progesterone (Cyclogest) 400 mg twice a day | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Full analysis
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The primary analysis was the full analysis of all includede patients having an embryo transfer.
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End points reporting groups
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Reporting group title |
Group <35 nmol/l
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Reporting group description |
HRT treatment including 6 mg estradiol (Estrofem) and vaginally progesterone (Cyclogest) 400 mg twice a day. If serum P4 is <35 nmol/l at the day of embryo transfer the progesterone regime is changed to 400 mg vaginally Cyclogest and additional 400 mg Cyclogest administered rectally starting at the day of transfer. | ||
Reporting group title |
Group >35 nmol/l
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Reporting group description |
HRT treatment including 6 mg estradiol (Estrofem) and vaginally progesterone (Cyclogest) 400 mg twice a day | ||
Subject analysis set title |
Full analysis
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The primary analysis was the full analysis of all includede patients having an embryo transfer.
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End point title |
Ongoing pregnancy | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 weeks
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Statistical analysis title |
X^2 test | ||||||||||||
Comparison groups |
Group <35 nmol/l v Group >35 nmol/l
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Number of subjects included in analysis |
488
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 1-sided | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
14 weeks
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Adverse event reporting additional description |
No adverse events were reported during the study.
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
23
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Frequency threshold for reporting non-serious adverse events: 5% | |||
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: There was no non-serious adverse events. However, few side effects do to discharge. |
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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 |