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Clinical Trial Comparing Endometrial Transformation With Subcutaneous Progesterone Versus Intramuscular Progesterone

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ClinicalTrials.gov Identifier: NCT02567552
Recruitment Status : Completed
First Posted : October 5, 2015
Results First Posted : March 19, 2018
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
IVI Barcelona

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Reproductive Techniques, Assisted
Interventions Drug: Subcutaneous progesterone
Drug: Intramuscular progesterone
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Period Title: Overall Study
Started 12 12
Completed 12 11 [1]
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
[1]
dropout by pain in the puncture site
Arm/Group Title Prolutex Prontogest Total
Hide Arm/Group Description

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
26.92  (5.32) 25.58  (2.39) 26.25  (4.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
12
 100.0%
12
 100.0%
24
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants 12 participants 24 participants
21.76  (2.88) 23.12  (2.79) 22.44  (2.86)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 12 participants 12 participants 24 participants
166.75  (5.10) 162.08  (3.50) 164.42  (4.90)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 12 participants 12 participants 24 participants
61.00  (10.05) 61.00  (8.55) 61.00  (9.12)
Blood Progesterone Level   [1] 
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 12 participants 12 participants 24 participants
1.31  (0.85) 1.44  (0.77) 1.37  (0.79)
[1]
Measure Description: Blood progesterone level in Day -2
Blood Estradiol Level   [1] 
Mean (Standard Deviation)
Unit of measure:  Pg/ml
Number Analyzed 12 participants 12 participants 24 participants
2020.35  (998.36) 2464.33  (1144.19) 2262.52  (1078.94)
[1]
Measure Description: Blood Estradiol Level in day -2
Blood LH level   [1] 
Mean (Standard Deviation)
Unit of measure:  Pg/ml
Number Analyzed 12 participants 12 participants 24 participants
1.25  (0.45) 1.24  (0.91) 1.25  (0.70)
[1]
Measure Description: Blood LH level in day -2
Endometrial Thickness   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 12 participants 12 participants 24 participants
8.88  (1.98) 9.58  (1.61) 9.23  (1.80)
[1]
Measure Description: Endometrial Thickness in day 0
1.Primary Outcome
Title Predecidual Transformation
Hide Description Histologic dating of the endometrium at day 5: early secretory phase, media secretory phase or late secretory phase
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description:

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Overall Number of Participants Analyzed 12 11
Measure Type: Number
Unit of Measure: participants
early secretory phase 1 2
media secretory phase 7 8
late secretory phase 4 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolutex, Prontogest
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3395
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Decidualization of Stromal Cell
Hide Description Rate of transformation of endometrial stromal fibroblasts into specialized secretory decidual cells (three categories: less than 25%, between 26% and 50%, and over 50%)
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description:

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Overall Number of Participants Analyzed 12 11
Measure Type: Number
Unit of Measure: participants
<25% of stromal cell 3 2
25-50% of stromal cell 3 7
> 50% of stromal cell 6 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolutex, Prontogest
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1523
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Primary Outcome
Title Endometrial Maturation Using Noyes' Criteria
Hide Description Endometrial dating of luteal phase days according to the Noyes criteria
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description:

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: days
9.08  (2.23) 7.64  (2.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolutex, Prontogest
Comments comparison between groups
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1189
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Endometrial Gene Expression
Hide Description Gene expression profile of endometrial
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description

We assessed the gene expression of 238 endometrial genes to detect differences in gene expression between treatments.

This analysis could not be performed in 1 patient of the prolutex group because of the poor quality of the sample collected

Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description:

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Overall Number of Participants Analyzed 11 11
Overall Number of Units Analyzed
Type of Units Analyzed: Endometrial genes
238 238
Measure Type: Number
Unit of Measure: Endometrial genes
differential expressed genes 28 28
the same trend of gene expression 210 210
5.Primary Outcome
Title Endometrial Gene Expression Difference
Hide Description Genes with a significantly high gene expression difference (adj-p-value < 0.05, Fold Change>3)
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
We assessed the expressed genes with a significantly high gene expression difference between treatments (adj-p-value < 0.05, Fold Change>3) This analysis could not be performed in 1 patient of the prolutex group because of the poor quality of the sample collected
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description:

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Overall Number of Participants Analyzed 11 11
Overall Number of Units Analyzed
Type of Units Analyzed: Endometrial genes
238 238
Measure Type: Number
Unit of Measure: Endometrial genes
expressed genes with fold change > 3 4 4
expressed genes without or with fold change < 3 234 234
6.Secondary Outcome
Title Endometrial Thickness
Hide Description Endometrial thickness measurement by means of transvaginal ultrasound.
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description:

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: mm
8.46  (2.66) 9.61  (1.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolutex, Prontogest
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2042
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Blood Estradiol Level
Hide Description Blood estradiol level on the day of follicular puncture
Time Frame day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description:

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
1384.06  (1122.80) 1208.58  (502.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolutex, Prontogest
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6262
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Blood Progesterone Level
Hide Description Blood progesterone level on the day of follicular puncture
Time Frame day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description:

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
14.40  (6.63) 10.92  (6.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolutex, Prontogest
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2301
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Blood LH Level
Hide Description Blood Luteinizing hormone level on the day of follicular puncture
Time Frame day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description:

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: pg/mL
2.32  (0.89) 2.75  (2.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolutex, Prontogest
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5118
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Blood Estradiol Level
Hide Description Blood estradiol level 5 days after progesterone treatment
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description:

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
257.88  (150.65) 246.45  (106.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolutex, Prontogest
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8371
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Blood Progesterone Level
Hide Description Blood progesterone level 5 days after progesterone treatment
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description:

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
3.16  (1.00) 11.04  (5.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolutex, Prontogest
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Blood LH Level
Hide Description Blood Luteinizing hormone level 5 days after progesterone treatment
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description:

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
1.30  (0.60) 2.92  (5.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolutex, Prontogest
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3107
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants With Side Effects During the Study
Hide Description Number of Participants with side effects during the study"
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description:

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: participants
5 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolutex, Prontogest
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 5 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prolutex Prontogest
Hide Arm/Group Description

Subcutaneous progesterone

Subcutaneous progesterone: subcutaneous progesterone 25 mg/day

Intramuscular progesterone

Intramuscular progesterone: intramuscular progesterone 50 mg/day

All-Cause Mortality
Prolutex Prontogest
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Prolutex Prontogest
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prolutex Prontogest
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/12 (41.67%)      4/12 (33.33%)    
General disorders     
Pain in injection site * [1]  0/12 (0.00%)  0 4/12 (33.33%)  6
Discomfort in injection site * [2]  3/12 (25.00%)  6 0/12 (0.00%)  0
Reproductive system and breast disorders     
Breast inflammation * [3]  2/12 (16.67%)  2 0/12 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Pain in injection site
[2]
Discomfort in injection site
[3]
Breast inflammation
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Evelin Lara Molina
Organization: IVI Barcelona
Phone: +34 93 531 63 00 ext 27503
Responsible Party: IVI Barcelona
ClinicalTrials.gov Identifier: NCT02567552     History of Changes
Other Study ID Numbers: 1412-BCN-087-AB
2015-000290-12 ( EudraCT Number )
First Submitted: October 2, 2015
First Posted: October 5, 2015
Results First Submitted: February 23, 2017
Results First Posted: March 19, 2018
Last Update Posted: March 18, 2019