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Trial record 30 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

Effect of hCG on Receptivity of the Human Endometrium

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ClinicalTrials.gov Identifier: NCT01786252
Recruitment Status : Completed
First Posted : February 7, 2013
Results First Posted : November 1, 2016
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Asgerally Fazleabas, Michigan State University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Infertility
Subfertility
Interventions Drug: human chorionic gonadotropin (hCG)
Drug: Placebo Comparator (for hCG)
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Drug: Human Chorionic Gonadotropin (hCG) IVF Media ("Global"-Trademark)
Hide Arm/Group Description

Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media ("Global"-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.

human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media ("Global"-trademark)

Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.

Placebo Comparator (for hCG): 50ul of IVF medium ("Global"-trademark) to mimic hCG infusion

Period Title: Overall Study
Started 7 8
Completed 7 8
Not Completed 0 0
Arm/Group Title Drug: Human Chorionic Gonadotropin (hCG) IVF Media ("Global"-Trademark) Total
Hide Arm/Group Description

Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media ("Global"-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.

human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media ("Global"-trademark)

Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.

Placebo Comparator (for hCG): 50ul of IVF medium ("Global"-trademark) to mimic hCG infusion

Total of all reporting groups
Overall Number of Baseline Participants 7 8 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 8 participants 15 participants
25.0  (0.976) 26.3  (1.35) 25.7  (3.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 15 participants
Female
7
 100.0%
8
 100.0%
15
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 7 participants 8 participants 15 participants
7
 100.0%
8
 100.0%
15
 100.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 7 participants 8 participants 15 participants
25.3  (3.8) 23.3  (2.2) 24.3  (3.2)
Gravidity  
Mean (Standard Deviation)
Unit of measure:  Number of times pregnant
Number Analyzed 7 participants 8 participants 15 participants
1.43  (1.13) 1.63  (1.30) 1.53  (1.19)
Parity  
Mean (Standard Deviation)
Unit of measure:  Number of deliveries
Number Analyzed 7 participants 8 participants 15 participants
1.14  (1.07) 1.25  (0.89) 1.2  (0.9)
Max E2 Level Prior to Oocyte Retrieval  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 7 participants 8 participants 15 participants
4097  (1112) 4428  (1425) 4274  (1255)
Average Ovulatory hCG Provided  
Mean (Standard Deviation)
Unit of measure:  IU
Number Analyzed 7 participants 8 participants 15 participants
6429  (2440) 7500  (2673) 7000  (2535)
Cycle Length  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 7 participants 8 participants 15 participants
12.29  (0.76) 13.25  (1.49) 12.8  (1.26)
Oocytes Retrieved  
Mean (Standard Deviation)
Unit of measure:  Number of oocytes
Number Analyzed 7 participants 8 participants 15 participants
19.1  (9.9) 20.5  (8.1) 19.9  (8.7)
1.Primary Outcome
Title Endometrial Staging in hCG Versus Vehicle Treated Patients
Hide Description All H&E-stained endometrial biopsies were analyzed in a blinded manner for endometrial dating and glandular and stromal development. Criteria for endometrial dating included the presence or absence of sub-nuclear vacuoles, which is one of the more reproducible features of the Noyes dating criteria. For the purposes of statistical analysis, the most advanced elements in each of the two endometrial compartments were considered. Data are specifically reported as days post-ovulation induction.
Time Frame 2 days following infusion of hCG or IVF media
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drug: Human Chorionic Gonadotropin (hCG) IVF Media ("Global"-Trademark)
Hide Arm/Group Description:

Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media ("Global"-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.

human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media ("Global"-trademark)

Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.

Placebo Comparator (for hCG): 50ul of IVF medium ("Global"-trademark) to mimic hCG infusion

Overall Number of Participants Analyzed 7 8
Mean (Standard Error)
Unit of Measure: days
Endometrial Gland Dating 4.0  (0.577) 4.6  (0.56)
Endometrial Stroma Dating 3.9  (0.46) 6.5  (0.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IVF Media ("Global"-Trademark)
Comments Statistical analysis to compare differences between endometrial glandular and stromal dating within the vehicle group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments Sidak-multiple comparison test was performed to detect significant differences between groups.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Drug: Human Chorionic Gonadotropin (hCG)
Comments Statistical analysis to compare differences between endometrial glandular and stromal dating within the hCG group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments Sidak-multiple comparison test was performed to detect significant differences between groups.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Drug: Human Chorionic Gonadotropin (hCG), IVF Media ("Global"-Trademark)
Comments Statistical analysis to compare stromal staging between hCG and IVF media group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments Sidak-multiple comparison test was performed to detect significant differences between groups.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Drug: Human Chorionic Gonadotropin (hCG), IVF Media ("Global"-Trademark)
Comments Statistical analysis to compare differences between endometrial glandular dating between hCG and IVF media groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments Sidak-multiple comparison test was performed to detect significant differences between groups.
2.Primary Outcome
Title Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Glands
Hide Description Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.
Time Frame 2 days following infusion of hCG or IVF media
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drug: Human Chorionic Gonadotropin (hCG) IVF Media ("Global"-Trademark)
Hide Arm/Group Description:

Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media ("Global"-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.

human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media ("Global"-trademark)

Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.

Placebo Comparator (for hCG): 50ul of IVF medium ("Global"-trademark) to mimic hCG infusion

Overall Number of Participants Analyzed 7 8
Mean (Standard Deviation)
Unit of Measure: D-HSCORE
111.9  (17.0) 84.59  (17.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Drug: Human Chorionic Gonadotropin (hCG), IVF Media ("Global"-Trademark)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Stroma
Hide Description Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.
Time Frame 2 days following infusion of hCG or IVF media
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drug: Human Chorionic Gonadotropin (hCG) IVF Media ("Global"-Trademark)
Hide Arm/Group Description:

Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media ("Global"-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.

human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media ("Global"-trademark)

Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.

Placebo Comparator (for hCG): 50ul of IVF medium ("Global"-trademark) to mimic hCG infusion

Overall Number of Participants Analyzed 7 8
Mean (Standard Deviation)
Unit of Measure: D-HSCORE
85.66  (18.7) 59.8  (15.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Drug: Human Chorionic Gonadotropin (hCG), IVF Media ("Global"-Trademark)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Primary Outcome
Title Expression of hCG Target C3 Protein by IHC in Endometrial Stroma
Hide Description Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.
Time Frame 2 days following infusion of hCG or IVF media
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drug: Human Chorionic Gonadotropin (hCG) IVF Media ("Global"-Trademark)
Hide Arm/Group Description:

Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media ("Global"-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.

human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media ("Global"-trademark)

Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.

Placebo Comparator (for hCG): 50ul of IVF medium ("Global"-trademark) to mimic hCG infusion

Overall Number of Participants Analyzed 7 8
Mean (Standard Deviation)
Unit of Measure: D-HSCORE
85.3  (11.6) 59.8  (21.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Drug: Human Chorionic Gonadotropin (hCG), IVF Media ("Global"-Trademark)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IVF Media ("Global"-Trademark) Drug: Human Chorionic Gonadotropin (hCG)
Hide Arm/Group Description Received IVF media infusion on Day 3 Post-Ovulation Induction Received hCG infusion on Day 3 Post-Ovulation Induction
All-Cause Mortality
IVF Media ("Global"-Trademark) Drug: Human Chorionic Gonadotropin (hCG)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IVF Media ("Global"-Trademark) Drug: Human Chorionic Gonadotropin (hCG)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IVF Media ("Global"-Trademark) Drug: Human Chorionic Gonadotropin (hCG)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Asgerally Fazleabas
Organization: Michigan State University
Phone: (517) 884-6031
EMail: asgi@hc.msu.edu
Publications:
Layout table for additonal information
Responsible Party: Asgerally Fazleabas, Michigan State University
ClinicalTrials.gov Identifier: NCT01786252     History of Changes
Other Study ID Numbers: Endo-hCG-755
IRB 12-755F ( Other Identifier: MSU )
First Submitted: February 5, 2013
First Posted: February 7, 2013
Results First Submitted: March 22, 2016
Results First Posted: November 1, 2016
Last Update Posted: February 24, 2017