Examination of Serum Progesterone Levels in an IVF Population Following Two Types of Egg Aspiration

January 17, 2012 updated by: Red Rock Fertility Center
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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Red Rock Fertility Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eva D Littman, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 37 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

IUI patients and IVF patients following a long lupron protocol cycle

Description

Inclusion Criteria:

  • Ages between 21-37
  • Cycle Day 3 FSH between 2-12
  • History of regular menstrual cycles between 24-34 days

Exclusion Criteria:

  • Previous IVF failure
  • Severe male factor
  • Severe obesity, BMI > 40
  • More than 20 follicles on ultrasound prior to retrieval

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
IVF population
Long Lupron IVF Population
IUI patients
Patients undergoing IUI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Red Rock Fertility Center

Collaborators

Watson Pharmaceuticals

Investigators

  • Principal Investigator: Eva D Littman, M.D., Red Rock Fertility Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

January 17, 2012

First Submitted That Met QC Criteria

January 17, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

January 20, 2012

Last Update Submitted That Met QC Criteria

January 17, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20111821

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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