Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Endometrial Receptivity, Ovarian Hyperstimulation Syndrome

Intervention / Treatment
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* Drug: GnRH agonist
* Drug: hCG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 33 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH agonist trigger<br>Induction of oocyte maturation with GnRH agonist | Drug: GnRH agonist<br>* GnRH agonist 1mg one dose<br>* Other names: lupron;|
| Active Comparator: hCG trigger<br>Induction of oocyte maturation with hCG | Drug: hCG<br>* 5,000 IU one dose<br>* Other names: Pregnyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial Gene Expression Profile | Microarray of gene expression in the midluteal phase | 7 days after trigger of oocyte maturation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger |  | At baseline and up to 7 days after trigger of oocyte maturation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GnRHa trigger, endometrial gene profile, quality of life