Phase 4
N=37
Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF
Endometriosis · Infertility
Bottom Line
View on ClinicalTrials.gov: NCT00621179 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Patients Who Responded to Controlled Ovarian Hyperstimulation — 7; 5; 3; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Leuprolide acetate in depot suspension (Drug); No intervention (Other)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Colorado Center for Reproductive Medicine
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients Who Responded to Controlled Ovarian Hyperstimulation |
7; 5; 3; 5 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00621179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.