{
  "FullStudy":{
    "Rank":218008,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513954",
          "OrgStudyIdInfo":{
            "OrgStudyId":"20111821"
          },
          "Organization":{
            "OrgFullName":"Red Rock Fertility Center",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Examination of Serum Progesterone Levels in an IVF Population Following Two Types of Egg Aspiration",
          "OfficialTitle":"Examination of Serum Progesterone Levels in an IVF Population Following Two Types of Egg Aspiration"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2013",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2013",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 17, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 20, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Red Rock Fertility Center",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Watson Pharmaceuticals",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to determine whether progesterone hormone levels differ following egg retrieval with a single lumen needle compared with a double lumen needle. These levels will be measured on several days before and after egg retrieval. The progesterone levels in each IVF group will also be compared to the group of women who are having IUI. In addition, these progesterone levels will be correlated with pregnancy outcomes.",
          "DetailedDescription":"This is a prospective randomized trial consisting of 3 groups of patients. Following a long lupron protocol IVF cycle there is a need for supplemental progesterone. The purpose of this study is to determine what range of serum levels should be observed when differing methods of egg aspiration have been administered and whether or not there is a correlation with outcomes or pregnancies."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Infertility, Female"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Infertility"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case Control"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"450",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"IVF population",
                "ArmGroupDescription":"Long Lupron IVF Population"
              },{
                "ArmGroupLabel":"IUI patients",
                "ArmGroupDescription":"Patients undergoing IUI"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAges between 21-37\nCycle Day 3 FSH between 2-12\nHistory of regular menstrual cycles between 24-34 days\n\nExclusion Criteria:\n\nPrevious IVF failure\nSevere male factor\nSevere obesity, BMI > 40\nMore than 20 follicles on ultrasound prior to retrieval",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Female",
          "MinimumAge":"21 Years",
          "MaximumAge":"37 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          },
          "StudyPopulation":"IUI patients and IVF patients following a long lupron protocol cycle",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Eva D Littman, M.D.",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"702-262-0079",
                "CentralContactEMail":"drevalittman@hotmail.com"
              },{
                "CentralContactName":"Maria (Charry) R Lopez, M.D.",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"702-262-0079",
                "CentralContactEMail":"charry@lasvegasfertility.com"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Eva D Littman, M.D.",
                "OverallOfficialAffiliation":"Red Rock Fertility Center",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Red Rock Fertility Center",
                "LocationStatus":"Recruiting",
                "LocationCity":"Las Vegas",
                "LocationState":"Nevada",
                "LocationZip":"89148",
                "LocationCountry":"United States",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Maria (Charry) R Lopez, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"702-262-0079",
                      "LocationContactEMail":"charry@lasvegasfertility.com"
                    },{
                      "LocationContactName":"Eva D Littman, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"702-262-0079",
                      "LocationContactEMail":"drevalittman@hotmail.com"
                    },{
                      "LocationContactName":"Eva D Littman, M.D.",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000007246",
                "ConditionMeshTerm":"Infertility"
              },{
                "ConditionMeshId":"D000007247",
                "ConditionMeshTerm":"Infertility, Female"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000005832",
                "ConditionAncestorTerm":"Genital Diseases, Male"
              },{
                "ConditionAncestorId":"D000005831",
                "ConditionAncestorTerm":"Genital Diseases, Female"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8873",
                "ConditionBrowseLeafName":"Infertility",
                "ConditionBrowseLeafAsFound":"Infertility",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8874",
                "ConditionBrowseLeafName":"Infertility, Female",
                "ConditionBrowseLeafAsFound":"Infertility, Female",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M7527",
                "ConditionBrowseLeafName":"Genital Diseases, Male",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7526",
                "ConditionBrowseLeafName":"Genital Diseases, Female",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}