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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Lawrence Engmann, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01606709
First received: May 19, 2012
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
  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 Blind (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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Endometrial gene expression profile [ Time Frame: 7 days after trigger of oocyte maturation ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   21 Years to 33 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606709

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

No publications provided

Responsible Party: Lawrence Engmann, MD, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01606709     History of Changes
Other Study ID Numbers: 11-168-1
Study First Received: May 19, 2012
Last Updated: May 25, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Adenoma
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Chorionic Gonadotropin
Triptorelin
Leuprolide
Deslorelin
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents

ClinicalTrials.gov processed this record on May 22, 2013