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

• Sponsor: UConn Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01606709
• Collaborator: Schering-Plough (Industry)
• Enrollment: 7
• Location: 1
• Arms: 2
• Actual Duration (Months): 32
• Patients Per Site Per Month: 0.2

Study Details

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	Phase
Endometrial Receptivity; Ovarian Hyperstimulation Syndrome	Drug: GnRH agonist; Drug: hCG	Phase 4

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
• Actual Enrollment: 7 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)
• Actual Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

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 Names: Pregnyl

Outcome Measures

Primary Outcome Measures

1. Endometrial Gene Expression Profile [7 days after trigger of oocyte maturation]

   Microarray of gene expression in the midluteal phase

Secondary Outcome Measures

1. Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger [At baseline and up to 7 days after trigger of oocyte maturation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 33 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	UCHC Division of Reproductive Endocrinology	Farmington	Connecticut	United States	06030

Sponsors and Collaborators

• UConn Health
• Schering-Plough

Investigators

• Principal Investigator: Lawrence Engmann, MD, MRCOG, UConn Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lawrence Engmann, MD, UConn Health
• ClinicalTrials.gov Identifier: NCT01606709
• Other Study ID Numbers: 11-168-1
• First Posted: May 28, 2012
• Last Update Posted: Nov 21, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lawrence Engmann, MD, UConn Health: GnRHa trigger; endometrial gene profile; quality of life
• Additional relevant MeSH terms: Ovarian Hyperstimulation Syndrome; Leuprolide

Study Results

Participant Flow

Arm/Group Title	GnRH Agonist Trigger	hCG Trigger
Arm/Group Description	Induction of oocyte maturation with GnRH agonist GnRH agonist: GnRH agonist 1mg one dose	Induction of oocyte maturation with hCG hCG: 5,000 IU one dose
Period Title: Overall Study
STARTED	4	3
COMPLETED	4	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	GnRH Agonist Trigger	hCG Trigger	Total
Arm/Group Description	Induction of oocyte maturation with GnRH agonist GnRH agonist: GnRH agonist 1mg one dose	Induction of oocyte maturation with hCG hCG: 5,000 IU one dose	Total of all reporting groups
Overall Participants	4	3	7
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 100%	3 100%	7 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	4 100%	3 100%	7 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Endometrial Gene Expression Profile
Description	Microarray of gene expression in the midluteal phase
Time Frame	7 days after trigger of oocyte maturation

Outcome Measure Data

Analysis Population Description

Inadequate RNA quality to completely analyze gene expression

Arm/Group Title	GnRH Agonist Trigger	hCG Trigger
Arm/Group Description	Induction of oocyte maturation with GnRH agonist GnRH agonist: GnRH agonist 1mg one dose	Induction of oocyte maturation with hCG hCG: 5,000 IU one dose
Measure Participants	0	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Too few patients completed survey to meaningfully analyze data

Arm/Group Title	GnRH Agonist Trigger	hCG Trigger
Arm/Group Description	Induction of oocyte maturation with GnRH agonist GnRH agonist: GnRH agonist 1mg one dose	Induction of oocyte maturation with hCG hCG: 5,000 IU one dose
Measure Participants	0	0

Adverse Events

Time Frame	3 weeks for each patient
Arm/Group Title	GnRH Agonist Trigger		hCG Trigger
Arm/Group Description	Induction of oocyte maturation with GnRH agonist GnRH agonist: GnRH agonist 1mg one dose		Induction of oocyte maturation with hCG hCG: 5,000 IU one dose
All Cause Mortality
	GnRH Agonist Trigger		hCG Trigger
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/3 (0%)
Serious Adverse Events
	GnRH Agonist Trigger		hCG Trigger
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	GnRH Agonist Trigger		hCG Trigger
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.