Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 90 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01606709
Recruitment Status : Terminated (Difficult to recruit patients)
First Posted : May 28, 2012
Results First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Lawrence Engmann, UConn Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Diagnostic
Conditions Endometrial Receptivity
Ovarian Hyperstimulation Syndrome
Interventions Drug: GnRH agonist
Drug: hCG
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GnRH Agonist Trigger hCG Trigger
Hide 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
Arm/Group Title GnRH Agonist Trigger hCG Trigger Total
Hide 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 Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
3
 100.0%
7
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
4
 100.0%
3
 100.0%
7
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Endometrial Gene Expression Profile
Hide Description Microarray of gene expression in the midluteal phase
Time Frame 7 days after trigger of oocyte maturation
Hide Outcome Measure Data
Hide Analysis Population Description
Inadequate RNA quality to completely analyze gene expression
Arm/Group Title GnRH Agonist Trigger hCG Trigger
Hide 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger
Hide Description [Not Specified]
Time Frame At baseline and up to 7 days after trigger of oocyte maturation
Hide Outcome Measure Data
Hide Analysis Population Description
Too few patients completed survey to meaningfully analyze data
Arm/Group Title GnRH Agonist Trigger hCG Trigger
Hide 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3 weeks for each patient
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GnRH Agonist Trigger hCG Trigger
Hide 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 (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
GnRH Agonist Trigger hCG Trigger
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GnRH Agonist Trigger hCG Trigger
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lawrence Engmann
Organization: UConnHealth
Phone: 8605258283
EMail: lengmann@uchc.edu
Layout table for additonal information
Responsible Party: Lawrence Engmann, UConn Health
ClinicalTrials.gov Identifier: NCT01606709     History of Changes
Other Study ID Numbers: 11-168-1
First Submitted: May 19, 2012
First Posted: May 28, 2012
Results First Submitted: April 17, 2017
Results First Posted: November 21, 2018
Last Update Posted: November 21, 2018