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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)


N/A
21 Years
33 Years
Open (Enrolling by invite only)
Female
Endometrial Receptivity, Ovarian Hyperstimulation Syndrome

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Trial Information

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)


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Outcome Measure:

Endometrial gene expression profile

Outcome Time Frame:

7 days after trigger of oocyte maturation

Safety Issue:

No

Principal Investigator

Lawrence Engmann, MD, MRCOG

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Connecticut Health Center

Authority:

United States: Institutional Review Board

Study ID:

11-168-1

NCT ID:

NCT01606709

Start Date:

April 2012

Completion Date:

July 2013

Related Keywords:

  • Endometrial Receptivity
  • Ovarian Hyperstimulation Syndrome
  • GnRHa trigger
  • endometrial gene profile
  • quality of life
  • Ovarian Hyperstimulation Syndrome
  • Adenoma

Name

Location

UCHC Division of Reproductive EndocrinologyFarmington, Connecticut  06030