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

Ovarian Hyperstimulation Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01606709
• Other study ID #: 11-168-1
• Status: Terminated
• Phase: Phase 4
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2018
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 33 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Receptivity
• Ovarian Hyperstimulation Syndrome

Intervention

Drug:
• GnRH agonist
GnRH agonist 1mg one dose
• hCG
5,000 IU one dose

Locations

Country	Name	City	State
United States	UCHC Division of Reproductive Endocrinology	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial Gene Expression Profile	Microarray of gene expression in the midluteal phase	7 days after trigger of oocyte maturation
Secondary	Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger		At baseline and up to 7 days after trigger of oocyte maturation