Trial Outcomes & Findings for Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF (NCT NCT00621179)
NCT ID: NCT00621179
Last Updated: 2021-08-10
Results Overview
Number of patients who responded to controlled ovarian stimulation as evidenced by implantation of embryo. Implantation confirmed by ultrasound at 6 1/2 weeks of pregnancy.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.
Results posted on
2021-08-10
Participant Flow
Participant milestones
| Measure |
Group 1
Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol
|
Group 2
Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation
|
Group 3
Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation
|
Group 4
Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
7
|
10
|
|
Overall Study
COMPLETED
|
12
|
8
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1
n=12 Participants
Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization
|
Group 2
n=8 Participants
Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation followed by in vitro fertilization
Leuprolide acetate in depot suspension: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
|
Group 3
n=7 Participants
Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation
Leuprolide acetate in depot suspension: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
|
Group 4
n=9 Participants
Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=12 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=9 Participants
|
36 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
33.75 years
STANDARD_DEVIATION 4.11 • n=12 Participants
|
33.0 years
STANDARD_DEVIATION 3.55 • n=8 Participants
|
33.86 years
STANDARD_DEVIATION 2.79 • n=7 Participants
|
32.67 years
STANDARD_DEVIATION 4.95 • n=9 Participants
|
33.33 years
STANDARD_DEVIATION 2.45 • n=36 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=12 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=9 Participants
|
36 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=12 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
8 participants
n=8 Participants
|
7 participants
n=7 Participants
|
9 participants
n=9 Participants
|
36 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.Number of patients who responded to controlled ovarian stimulation as evidenced by implantation of embryo. Implantation confirmed by ultrasound at 6 1/2 weeks of pregnancy.
Outcome measures
| Measure |
Group 1
n=12 Participants
Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention
No intervention
|
Group 2
n=8 Participants
Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation followed by in vitro fertilization
Leuprolide acetate in depot suspension: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
|
Group 3
n=6 Participants
Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation
Leuprolide acetate in depot suspension: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
|
Group 4
n=9 Participants
Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention
No intervention
|
|---|---|---|---|---|
|
Patients Who Responded to Controlled Ovarian Hyperstimulation
|
7 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4
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