Clinical Trial Results:
Impact of luteal phase support with vaginal progesterone on the clinical pregnancy rate in IUI cycles stimulated with gonadotrophins: a prospective randomized multicentre study.
Summary
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EudraCT number |
2010-023867-17 |
Trial protocol |
BE |
Global end of trial date |
22 Oct 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Feb 2021
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First version publication date |
14 Feb 2021
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Other versions |
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Summary report(s) |
Publication |
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 |
S52775
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01826747 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
UZLeuven
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Sponsor organisation address |
Herestraat 49, Leuven, Belgium, 3000
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Public contact |
Karen Peeraer, UZLeuven, +32 16343650, karen.peeraer@uzleuven.be
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Scientific contact |
Karen Peeraer, UZLeuven, +32 16343650, karen.peeraer@uzleuven.be
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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 |
22 Oct 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
22 Oct 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Oct 2015
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
Test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate when compared to no luteal phase support in a program of intrauterine insemination after controlled ovarian stimulation with gonadotrophins
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Protection of trial subjects |
No measurements were taken. Study did not cause additional pain or distress.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Apr 2011
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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 |
Belgium: 393
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Worldwide total number of subjects |
393
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EEA total number of subjects |
393
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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) |
393
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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 |
All couples with an indication for intrauterine insemination (IUI) such as unexplained infertility, mild male factor infertility, or minimal�mild endometriosis were eligible for this study during their first IUI cycle. Before their inclusion in the study, all couples underwent a complete infertility evaluation. | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
first IUI cycle Physical examination, medical history check serum hormone assay between day 2 and 5 of menstrual cycle pelvic ultrasound assessment of tubal patency either by hysterosalpingography or laparoscopy, and semen analysis <43 years old, BMI =<30 at least one patent tube partner sperm motile of >= 5 million | ||||||||||||||||||||||||
Period 1
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Period 1 title |
overall trial (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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control group without luteal phase support | ||||||||||||||||||||||||
Arm description |
control group: standard of care intrauterine insemination | ||||||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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study group with luteal phase support | ||||||||||||||||||||||||
Arm description |
study group with luteal phase support. Vaginal progesterone gel used | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Crinone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Gel
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Routes of administration |
Vaginal use
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Dosage and administration details |
once daily in the morning starting on the day after IUI until the time of pregnancy test (b-hCG) about 15 days after IUI. Crinone was administered by an applicator that delivered 1.125 g of vaginal gel containing 90 mg of progesterone.
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
control group without luteal phase support
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Reporting group description |
control group: standard of care intrauterine insemination | ||
Reporting group title |
study group with luteal phase support
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Reporting group description |
study group with luteal phase support. Vaginal progesterone gel used |
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End point title |
Clinical pregnancy rate [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Primary endpoint is clinical pregnancy rate. 34 of the 202 patients in the study group became pregnant (16.8%). 21 of the 191 patients in the control group became pregnant (11%)
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: not specified in publication |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Safety was not an endpoint of 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 |
14.0
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Frequency threshold for reporting non-serious adverse events: 0% | |||
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: adverse events not collected |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/27565253 |