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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Lawrence Engmann, University of Connecticut Health Center.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01606709
First Posted: May 28, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Lawrence Engmann, University of Connecticut Health Center
  Purpose

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 Intervention
Endometrial Receptivity Ovarian Hyperstimulation Syndrome Drug: GnRH agonist Drug: hCG

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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)

Resource links provided by NLM:


Further study details as provided by Lawrence Engmann, University of Connecticut Health Center:

Primary Outcome Measures:
  • Endometrial gene expression profile [ Time Frame: 7 days after trigger of oocyte maturation ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
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)
Arms Assigned Interventions
Experimental: GnRH agonist trigger
Induction of oocyte maturation with GnRH agonist
Drug: GnRH agonist
GnRH agonist 1mg one dose
Other Names:
  • leuprolide acetate,
  • lupron
Active Comparator: hCG trigger
Induction of oocyte maturation with hCG
Drug: hCG
5,000 IU one dose
Other Name: Pregnyl

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 33 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Connecticut
UCHC Division of Reproductive Endocrinology
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Schering-Plough
Investigators
Principal Investigator: Lawrence Engmann, MD, MRCOG UConn Health
  More Information

Responsible Party: Lawrence Engmann, MD, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01606709     History of Changes
Other Study ID Numbers: 11-168-1
First Submitted: May 19, 2012
First Posted: May 28, 2012
Last Update Posted: October 12, 2017
Last Verified: May 2012

Keywords provided by Lawrence Engmann, University of Connecticut Health Center:
GnRHa trigger
endometrial gene profile
quality of life

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hormones
Deslorelin
Triptorelin Pamoate
Leuprolide
Chorionic Gonadotropin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents