EndometriosisPhase 4IntegrinIVFNCT00621179
Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF
A Phase 4 study testing Leuprolide acetate in depot suspension in people with Endometriosis and Infertility, run by Colorado Center for Reproductive Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 42 years, women only
- Conditions the study is for
- Endometriosis, Infertility
- What is being tested?
- Leuprolide acetate in depot suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jan 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertility
- Surgical diagnosis of endometriosis
- Normal ovarian reserve testing
- Regular menses
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, 80124
About this study
Official title: Do Endometrial Implantation Markers Predict in Vitro Fertilization-embryo Transfer Cycle Outcomes in Endometriosis Patients Pretreated With Leuprolide Acetate in Depot Suspension?
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
Read the detailed description
See summary
- Conditions
- Endometriosis, Infertility
- Being tested
- Leuprolide acetate in depot suspension, No intervention
- Keywords
- Endometriosis,infertility,in vitro fertilization
- Medical subject headings
- Endometriosis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprolide acetate in depot suspensionDrug
Also called Depot Lupron
Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention Receives: Other: No intervention |
| Group 2 | Experimental | 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 Receives: Drug: Leuprolide acetate in depot suspension |
| Group 3 | Experimental | 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 Receives: Drug: Leuprolide acetate in depot suspension |
| Group 4 | Active comparator | Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startMar 2003
- Primary completionAug 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado Center for Reproductive Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Surrey, M.D., Colorado Center for Reproductive Medicine
- Investigators
- Eric S Surrey, M.D., Principal investigator, Colorado Center for Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621179
- Sponsor's protocol ID
- IntegrinIVF
- Acronym
- IntegrinIVF
- Status last verified
- Aug 2021
- First submitted
- 13 Feb 2008
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Surrey ES, Silverberg KM, Surrey MW, Schoolcraft WB. Effect of prolonged gonadotropin-releasing hormone agonist therapy on the outcome of in vitro fertilization-embryo transfer in patients with endometriosis. Fertil Steril. 2002 Oct;78(4):699-704. doi: 10.1016/s0015-0282(02)03373-3.
PubMed 12372443Lessey BA, Castelbaum AJ, Sawin SW, Buck CA, Schinnar R, Bilker W, Strom BL. Aberrant integrin expression in the endometrium of women with endometriosis. J Clin Endocrinol Metab. 1994 Aug;79(2):643-9. doi: 10.1210/jcem.79.2.7519194.
PubMed 7519194Surrey ES, Lietz AK, Gustofson RL, Minjarez DA, Schoolcraft WB. Does endometrial integrin expression in endometriosis patients predict enhanced in vitro fertilization cycle outcomes after prolonged GnRH agonist therapy? Fertil Steril. 2010 Feb;93(2):646-51. doi: 10.1016/j.fertnstert.2008.12.023. Epub 2009 Jan 26.
PubMed 19171333
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Endometrial Implantation Markers Predict in Vitro Fertilization-embryo Transfer Cycle Outcomes in Endometriosis Patients Pretreated With Leuprolide Acetate in Depot Suspension?
- ClinicalTrials.gov ID
- NCT00621179
- Acronym / sponsor ID
- IntegrinIVF / IntegrinIVF
- Conditions
- Endometriosis, Infertility
- Keywords
- Endometriosis,infertility,in vitro fertilization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Colorado Center for Reproductive MedicineUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Posted 5 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: No interventionPositive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention |
| Group 2 | Experimental | Drug: Leuprolide acetate in depot suspensionIntervention: 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 |
| Group 3 | Experimental | Drug: Leuprolide acetate in depot suspensionNegative 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 | Active comparator | Other: No interventionNegative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Infertility
- Surgical diagnosis of endometriosis
- Normal ovarian reserve testing
- Regular menses
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leuprolide acetate in depot suspensionAlso: Depot LupronLeuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3 | Drug | Group 2, Group 3 |
| No intervention | Other | Group 1, Group 4 |
Primary outcome
Patients Who Responded to Controlled Ovarian Hyperstimulation
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12372443Surrey ES, Silverberg KM, Surrey MW, Schoolcraft WB. Effect of prolonged gonadotropin-releasing hormone agonist therapy on the outcome of in vitro fertilization-embryo transfer in patients with endometriosis. Fertil Steril. 2002 Oct;78(4):699-704. doi: 10.1016/s0015-0282(02)03373-3.
- Background: PubMed 7519194Lessey BA, Castelbaum AJ, Sawin SW, Buck CA, Schinnar R, Bilker W, Strom BL. Aberrant integrin expression in the endometrium of women with endometriosis. J Clin Endocrinol Metab. 1994 Aug;79(2):643-9. doi: 10.1210/jcem.79.2.7519194.
- Derived from this study: PubMed 19171333Surrey ES, Lietz AK, Gustofson RL, Minjarez DA, Schoolcraft WB. Does endometrial integrin expression in endometriosis patients predict enhanced in vitro fertilization cycle outcomes after prolonged GnRH agonist therapy? Fertil Steril. 2010 Feb;93(2):646-51. doi: 10.1016/j.fertnstert.2008.12.023. Epub 2009 Jan 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric S Surrey, M.D. principal investigator
Colorado Center for Reproductive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Leuprolide acetate in depot suspension in people with Endometriosis and Infertility, run by Colorado Center for Reproductive Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Who Responded to Controlled Ovarian Hyperstimulation (time frame: Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00621179, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.