Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation
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|ClinicalTrials.gov Identifier: NCT01606709|
Recruitment Status : Terminated (Difficult to recruit patients)
First Posted : May 28, 2012
Results First Posted : November 21, 2018
Last Update Posted : November 21, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Receptivity Ovarian Hyperstimulation Syndrome||Drug: GnRH agonist Drug: hCG||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|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)|
|Actual Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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
- Endometrial Gene Expression Profile [ Time Frame: 7 days after trigger of oocyte maturation ]Microarray of gene expression in the midluteal phase
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606709
|United States, Connecticut|
|UCHC Division of Reproductive Endocrinology|
|Farmington, Connecticut, United States, 06030|
|Principal Investigator:||Lawrence Engmann, MD, MRCOG||UConn Health|