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

This study is currently recruiting participants.
Verified January 2012 by Red Rock Fertility Center
Sponsor:
Collaborator:
Watson Pharmaceuticals
Information provided by (Responsible Party):
Red Rock Fertility Center
ClinicalTrials.gov Identifier:
NCT01513954
First received: January 17, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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
Infertility, Female

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Examination of Serum Progesterone Levels in an IVF Population Following Two Types of Egg Aspiration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Red Rock Fertility Center:

Estimated Enrollment: 450
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
IVF population
Long Lupron IVF Population
IUI patients
Patients undergoing IUI

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.

  Eligibility

Ages Eligible for Study:   21 Years to 37 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Red Rock Fertility Center
ClinicalTrials.gov Identifier: NCT01513954     History of Changes
Other Study ID Numbers: 20111821
Study First Received: January 17, 2012
Last Updated: January 17, 2012
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013