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

Primary Purpose

Endometrial Receptivity, Ovarian Hyperstimulation Syndrome

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

GnRH agonist

hCG

About this trial

This is an interventional diagnostic trial for Endometrial Receptivity focused on measuring GnRHa trigger, endometrial gene profile, quality of life

Eligibility Criteria

21 Years - 33 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

UCHC Division of Reproductive Endocrinology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GnRH agonist trigger

hCG trigger

Arm Description

Induction of oocyte maturation with GnRH agonist

Induction of oocyte maturation with hCG

Outcomes

Primary Outcome Measures

Endometrial Gene Expression Profile

Microarray of gene expression in the midluteal phase

Secondary Outcome Measures

Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger

Full Information

NCT ID

NCT01606709

First Posted

May 19, 2012

Last Updated

October 22, 2018

Sponsor

UConn Health

Collaborators

Schering-Plough

1. Study Identification

Unique Protocol Identification Number

NCT01606709

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Terminated

Why Stopped

Difficult to recruit patients

Study Start Date

April 2012 (Actual)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UConn Health

Collaborators

Schering-Plough

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Receptivity, Ovarian Hyperstimulation Syndrome

Keywords

GnRHa trigger, endometrial gene profile, quality of life

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GnRH agonist trigger

Arm Type

Experimental

Arm Description

Induction of oocyte maturation with GnRH agonist

Arm Title

hCG trigger

Arm Type

Active Comparator

Arm Description

Induction of oocyte maturation with hCG

Intervention Type

Drug

Intervention Name(s)

GnRH agonist

Other Intervention Name(s)

leuprolide acetate,, lupron

Intervention Description

GnRH agonist 1mg one dose

Intervention Type

Drug

Intervention Name(s)

hCG

Other Intervention Name(s)

Pregnyl

Intervention Description

5,000 IU one dose

Primary Outcome Measure Information:

Title

Endometrial Gene Expression Profile

Description

Microarray of gene expression in the midluteal phase

Time Frame

7 days after trigger of oocyte maturation

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

33 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lawrence Engmann, MD, MRCOG

Organizational Affiliation

UConn Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCHC Division of Reproductive Endocrinology

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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