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

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: NCT01513954
Recruitment Status : Unknown
Verified January 2012 by Red Rock Fertility Center.
Recruitment status was:  Recruiting
First Posted : January 20, 2012
Last Update Posted : January 20, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Infertility, Female

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 Design

Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Examination of Serum Progesterone Levels in an IVF Population Following Two Types of Egg Aspiration
Study Start Date : January 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
IUI patients and IVF patients following a long lupron protocol cycle
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513954


Contacts
Contact: Eva D Littman, M.D. 702-262-0079 drevalittman@hotmail.com
Contact: Maria (Charry) R Lopez, M.D. 702-262-0079 charry@lasvegasfertility.com

Locations
United States, Nevada
Red Rock Fertility Center Recruiting
Las Vegas, Nevada, United States, 89148
Contact: Maria (Charry) R Lopez, MD    702-262-0079    charry@lasvegasfertility.com   
Contact: Eva D Littman, MD    702-262-0079    drevalittman@hotmail.com   
Principal Investigator: Eva D Littman, M.D.         
Sponsors and Collaborators
Red Rock Fertility Center
Watson Pharmaceuticals
Investigators
Principal Investigator: Eva D Littman, M.D. Red Rock Fertility Center
More Information

Responsible Party: Red Rock Fertility Center
ClinicalTrials.gov Identifier: NCT01513954     History of Changes
Other Study ID Numbers: 20111821
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: January 2012

Keywords provided by Red Rock Fertility Center:
Infertility

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs