A Prospective Comparison of Transcriptional Profiling of Luteal Phase Endometrial Biopsies After Induction of Oocyte Maturation With a Gonadotropin Releasing Hormone (GnRH) Agonist or Human Chorionic Gonadotropins (hCG)
| Registry | NCT01606709 |
|---|---|
| Status | Terminated - Difficult to recruit patients |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: single, diagnostic |
| Enrollment | 7 (Actual) |
| Sponsor | UConn Health (Other); collaborators: Schering-Plough |
| Conditions | Endometrial Receptivity, Ovarian Hyperstimulation Syndrome |
| Interventions | GnRH agonist, hCG (Drug) |
| Dates | start 2012-04-01, primary completion 2014-12-01, completion 2014-12-01, first posted 2012-05-28, last updated 2018-11-21 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Endometrial Receptivity All trials for Ovarian Hyperstimulation Syndrome All trials of GnRH agonist All trials of hCG
The purpose of this study is to compare gene expression profiles in endometrial biopsies during the window of implantation after triggers of oocyte maturation using GnRH agonist or hCG and compared with their natural cycles in order to identify genes that may be dysregulated in GnRH agonist-triggered cycles.
The investigators also intend to evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.
Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation (COH) which may result in significant morbidity and rarely mortality as well as significant financial and psychological distress. The use of a GnRH agonist for induction of final oocyte maturation in ovarian stimulation cycles utilizing GnRH antagonist for pituitary suppression has proven to be an effective method of preventing the risk of OHSS development.
Unfortunately, some studies, but not all, have also reported lower pregnancy rates in these cycles as compared to cycles using hCG trigger and this has been attributed to possible impaired endometrial receptivity.
The investigators intend to obtain endometrial biopsies collected from the same subject in a natural cycle and then a biopsy during either a GnRH agonist or hCG triggered stimulation. Expression profiles of mRNAs will first be screened using microarray technology. Relative levels of specific mRNAs that display altered expression in the GnRH-triggered samples, as assayed by microarray, will then be confirmed by real-time, quantitative reverse transcription/polymerase chain reaction (Q-PCR). The investigators shall also evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| GnRH agonist trigger | Experimental | Drug: GnRH agonist | Induction of oocyte maturation with GnRH agonist |
| hCG trigger | Active comparator | Drug: hCG | Induction of oocyte maturation with hCG |
Sex: Female, ages: 21 Years to 33 Years, accepts healthy volunteers
Inclusion Criteria: * Oocyte donors * Ages between 21 and 33 * Normal baseline serum FSH < 10mIU/mL Exclusion Criteria: * Hypothalamic dysfunction * Smokers * Baseline serum FSH ≥ 10mIU/mL
| Milestone | GnRH Agonist Trigger | hCG Trigger |
|---|---|---|
| Started | 4 | 3 |
| Completed | 4 | 3 |
| Not completed | 0 | 0 |
Time frame: 3 weeks for each patient
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| GnRH Agonist Trigger | 0/4 (0.0%) | 0/4 (0.0%) | 0/4 (0.0%) |
| hCG Trigger | 0/3 (0.0%) | 0/3 (0.0%) | 0/3 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| UCHC Division of Reproductive Endocrinology | Farmington, Connecticut | United States |