Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation
Information source: University of Connecticut Health Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometrial Receptivity; Ovarian Hyperstimulation Syndrome
Intervention: GnRH agonist (Drug); hCG (Drug)
Phase: N/A
Status: Enrolling by invitation
Sponsored by: University of Connecticut Health Center Official(s) and/or principal investigator(s): Lawrence Engmann, MD, MRCOG, Principal Investigator, Affiliation: University of Connecticut Health Center
Summary
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
Clinical Details
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)
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Primary outcome: Endometrial gene expression profile
Secondary outcome: Quality of life survey after ovarian stimulation and GnRHa or hCG trigger
Detailed description:
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 33 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
UCHC Division of Reproductive Endocrinology, Farmington, Connecticut 06030, United States
Additional Information
Starting date: April 2012
Last updated: May 25, 2012
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