Trial Outcomes & Findings for Effect of hCG on Receptivity of the Human Endometrium (NCT NCT01786252)
NCT ID: NCT01786252
Last Updated: 2017-02-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
2 days following infusion of hCG or IVF media
Results posted on
2017-02-24
Participant Flow
Participant milestones
| Measure |
Drug: Human Chorionic Gonadotropin (hCG)
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)
|
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 Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of hCG on Receptivity of the Human Endometrium
Baseline characteristics by cohort
| Measure |
Drug: Human Chorionic Gonadotropin (hCG)
n=7 Participants
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)
|
IVF Media ("Global"-Trademark)
n=8 Participants
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
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.0 years
STANDARD_DEVIATION 0.976 • n=5 Participants
|
26.3 years
STANDARD_DEVIATION 1.35 • n=7 Participants
|
25.7 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Gender
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
BMI
|
25.3 kg/m^2
STANDARD_DEVIATION 3.8 • n=5 Participants
|
23.3 kg/m^2
STANDARD_DEVIATION 2.2 • n=7 Participants
|
24.3 kg/m^2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Gravidity
|
1.43 Number of times pregnant
STANDARD_DEVIATION 1.13 • n=5 Participants
|
1.63 Number of times pregnant
STANDARD_DEVIATION 1.30 • n=7 Participants
|
1.53 Number of times pregnant
STANDARD_DEVIATION 1.19 • n=5 Participants
|
|
Parity
|
1.14 Number of deliveries
STANDARD_DEVIATION 1.07 • n=5 Participants
|
1.25 Number of deliveries
STANDARD_DEVIATION 0.89 • n=7 Participants
|
1.2 Number of deliveries
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Max E2 Level Prior to Oocyte Retrieval
|
4097 ng/mL
STANDARD_DEVIATION 1112 • n=5 Participants
|
4428 ng/mL
STANDARD_DEVIATION 1425 • n=7 Participants
|
4274 ng/mL
STANDARD_DEVIATION 1255 • n=5 Participants
|
|
Average Ovulatory hCG Provided
|
6429 IU
STANDARD_DEVIATION 2440 • n=5 Participants
|
7500 IU
STANDARD_DEVIATION 2673 • n=7 Participants
|
7000 IU
STANDARD_DEVIATION 2535 • n=5 Participants
|
|
Cycle Length
|
12.29 Days
STANDARD_DEVIATION 0.76 • n=5 Participants
|
13.25 Days
STANDARD_DEVIATION 1.49 • n=7 Participants
|
12.8 Days
STANDARD_DEVIATION 1.26 • n=5 Participants
|
|
Oocytes Retrieved
|
19.1 number of oocytes
STANDARD_DEVIATION 9.9 • n=5 Participants
|
20.5 number of oocytes
STANDARD_DEVIATION 8.1 • n=7 Participants
|
19.9 number of oocytes
STANDARD_DEVIATION 8.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 days following infusion of hCG or IVF mediaAll 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.
Outcome measures
| Measure |
Drug: Human Chorionic Gonadotropin (hCG)
n=7 Participants
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)
|
IVF Media ("Global"-Trademark)
n=8 Participants
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
|
|---|---|---|
|
Endometrial Staging in hCG Versus Vehicle Treated Patients
Endometrial Gland Dating
|
4.0 days
Standard Error 0.577
|
4.6 days
Standard Error 0.56
|
|
Endometrial Staging in hCG Versus Vehicle Treated Patients
Endometrial Stroma Dating
|
3.9 days
Standard Error 0.46
|
6.5 days
Standard Error 0.57
|
PRIMARY outcome
Timeframe: 2 days following infusion of hCG or IVF mediaStaining 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.
Outcome measures
| Measure |
Drug: Human Chorionic Gonadotropin (hCG)
n=7 Participants
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)
|
IVF Media ("Global"-Trademark)
n=8 Participants
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
|
|---|---|---|
|
Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Glands
|
111.9 D-HSCORE
Standard Deviation 17.0
|
84.59 D-HSCORE
Standard Deviation 17.9
|
PRIMARY outcome
Timeframe: 2 days following infusion of hCG or IVF mediaStaining 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.
Outcome measures
| Measure |
Drug: Human Chorionic Gonadotropin (hCG)
n=7 Participants
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)
|
IVF Media ("Global"-Trademark)
n=8 Participants
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
|
|---|---|---|
|
Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Stroma
|
85.66 D-HSCORE
Standard Deviation 18.7
|
59.8 D-HSCORE
Standard Deviation 15.1
|
PRIMARY outcome
Timeframe: 2 days following infusion of hCG or IVF mediaStaining 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.
Outcome measures
| Measure |
Drug: Human Chorionic Gonadotropin (hCG)
n=7 Participants
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)
|
IVF Media ("Global"-Trademark)
n=8 Participants
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
|
|---|---|---|
|
Expression of hCG Target C3 Protein by IHC in Endometrial Stroma
|
85.3 D-HSCORE
Standard Deviation 11.6
|
59.8 D-HSCORE
Standard Deviation 21.6
|
Adverse Events
IVF Media ("Global"-Trademark)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Drug: Human Chorionic Gonadotropin (hCG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place