Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation
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
Drug: GnRH agonist
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||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)|
- Endometrial gene expression profile [ Time Frame: 7 days after trigger of oocyte maturation ] [ Designated as safety issue: No ]
- Quality of life survey after ovarian stimulation and GnRHa or hCG trigger [ Time Frame: At baseline and up to 7 days after trigger of oocyte maturation ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: GnRH agonist trigger
Induction of oocyte maturation with GnRH agonist
Drug: GnRH agonist
GnRH agonist 1mg one dose
Active Comparator: hCG trigger
Induction of oocyte maturation with hCG
5,000 IU one dose
Other Name: Pregnyl
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606709
|United States, Connecticut|
|UCHC Division of Reproductive Endocrinology|
|Farmington, Connecticut, United States, 06030|
|Principal Investigator:||Lawrence Engmann, MD, MRCOG||University of Connecticut Health Center|