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

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ClinicalTrials.gov Identifier: NCT01606709
Recruitment Status : Unknown
Verified May 2012 by Lawrence Engmann, University of Connecticut Health Center.
Recruitment status was:  Enrolling by invitation
First Posted : May 28, 2012
Last Update Posted : May 28, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Endometrial Receptivity Ovarian Hyperstimulation Syndrome Drug: GnRH agonist Drug: hCG

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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)
Study Start Date : April 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Deslorelin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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

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

United States, Connecticut
UCHC Division of Reproductive Endocrinology
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
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 Posted: May 28, 2012    Key Record Dates
Last Update Posted: May 28, 2012
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
Triptorelin Pamoate
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