Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation
Primary Purpose
Endometrial Receptivity, Ovarian Hyperstimulation Syndrome
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
GnRH agonist
hCG
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometrial Receptivity focused on measuring GnRHa trigger, endometrial gene profile, quality of life
Eligibility 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
Sites / Locations
- UCHC Division of Reproductive Endocrinology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GnRH agonist trigger
hCG trigger
Arm Description
Induction of oocyte maturation with GnRH agonist
Induction of oocyte maturation with hCG
Outcomes
Primary Outcome Measures
Endometrial Gene Expression Profile
Microarray of gene expression in the midluteal phase
Secondary Outcome Measures
Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger
Full Information
NCT ID
NCT01606709
First Posted
May 19, 2012
Last Updated
October 22, 2018
Sponsor
UConn Health
Collaborators
Schering-Plough
1. Study Identification
Unique Protocol Identification Number
NCT01606709
Brief Title
Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation
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 Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Difficult to recruit patients
Study Start Date
April 2012 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
Schering-Plough
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Receptivity, Ovarian Hyperstimulation Syndrome
Keywords
GnRHa trigger, endometrial gene profile, quality of life
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GnRH agonist trigger
Arm Type
Experimental
Arm Description
Induction of oocyte maturation with GnRH agonist
Arm Title
hCG trigger
Arm Type
Active Comparator
Arm Description
Induction of oocyte maturation with hCG
Intervention Type
Drug
Intervention Name(s)
GnRH agonist
Other Intervention Name(s)
leuprolide acetate,, lupron
Intervention Description
GnRH agonist 1mg one dose
Intervention Type
Drug
Intervention Name(s)
hCG
Other Intervention Name(s)
Pregnyl
Intervention Description
5,000 IU one dose
Primary Outcome Measure Information:
Title
Endometrial Gene Expression Profile
Description
Microarray of gene expression in the midluteal phase
Time Frame
7 days after trigger of oocyte maturation
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
33 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Engmann, MD, MRCOG
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCHC Division of Reproductive Endocrinology
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation
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