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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01513954
• Other study ID #: 20111821
• Status: Recruiting
• Phase: N/A
• First received: January 17, 2012
• Last updated: January 17, 2012
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2012
• Source: Red Rock Fertility Center
• Contact: Eva D Littman, M.D.
• Phone: 702-262-0079
• Email: drevalittman[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 37 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Locations

Country	Name	City	State
United States	Red Rock Fertility Center	Las Vegas	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
Red Rock Fertility Center	Watson Pharmaceuticals

Country where clinical trial is conducted

United States,