Endometriosis, Infertility
Conditions
Keywords
Endometriosis,infertility,in vitro fertilization
Brief summary
This prospective randomized trial evaluates whether one can predict which infertile women with endometriosis who are candidates for in vitro fertilization will benefit from prolonged therapy with a GnRH agonist by the determination of the absence of endometrial expression of the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for in vitro fertilization and then undergo randomization to a three month course of a depot preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian stimulation or standard therapy. prio
Detailed description
See summary
Interventions
DRUGLeuprolide acetate in depot suspension
Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
OTHERNo intervention
Sponsors
Colorado Center for Reproductive Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* Infertility * Surgical diagnosis of endometriosis * Normal ovarian reserve testing * Regular menses
Exclusion criteria
* Irregular menses * Undiagnosed abnormal uterine bleeding * Pregnancy * Prior adverse reaction to any GnRH agonist * Ovarian cystic or solid mass \> 3cm in mean diameter at study entry * Use of a depot preparation of a GnRh agonist or any hormonal therapy for endometriosis within 6 months of study entry * Current hepatic, renal, hematologic or psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients Who Responded to Controlled Ovarian Hyperstimulation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization | 12 |
| 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 followed by in vitro fertilization
Leuprolide acetate in depot suspension: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3 | 8 |
| 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
Leuprolide acetate in depot suspension: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3 | 7 |
| Group 4 Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. | 9 |
| Total | 36 |
Baseline characteristics
| Characteristic | Group 2 | Group 3 | Group 4 | Group 1 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 7 Participants | 9 Participants | 12 Participants | 36 Participants |
| Age, Continuous | 33.0 years STANDARD_DEVIATION 3.55 | 33.86 years STANDARD_DEVIATION 2.79 | 32.67 years STANDARD_DEVIATION 4.95 | 33.75 years STANDARD_DEVIATION 4.11 | 33.33 years STANDARD_DEVIATION 2.45 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 8 participants | 7 participants | 9 participants | 12 participants | 36 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 9 Participants | 12 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 8 | 0 / 7 | 0 / 9 |
| other Total, other adverse events | 0 / 12 | 0 / 8 | 0 / 7 | 0 / 9 |
| serious Total, serious adverse events | 0 / 12 | 0 / 8 | 0 / 7 | 0 / 9 |
Outcome results
Primary
Patients Who Responded to Controlled Ovarian Hyperstimulation
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.
Time frame: Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Patients Who Responded to Controlled Ovarian Hyperstimulation | 7 Participants |
| Group 2 | Patients Who Responded to Controlled Ovarian Hyperstimulation | 5 Participants |
| Group 3 | Patients Who Responded to Controlled Ovarian Hyperstimulation | 3 Participants |
| Group 4 | Patients Who Responded to Controlled Ovarian Hyperstimulation | 5 Participants |