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

NCT ID: NCT01513954

Last Updated: 2012-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility, Female

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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IVF population

Long Lupron IVF Population

No interventions assigned to this group

IUI patients

Patients undergoing IUI

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Watson Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Red Rock Fertility Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eva D Littman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Red Rock Fertility Center

Locations

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Red Rock Fertility Center

Las Vegas, Nevada, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Eva D Littman, M.D.

Role: CONTACT

702-262-0079

Maria (Charry) R Lopez, M.D.

Role: CONTACT

702-262-0079

Facility Contacts

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Maria (Charry) R Lopez, MD

Role: primary

702-262-0079

Eva D Littman, MD

Role: backup

702-262-0079

Other Identifiers

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20111821

Identifier Type: -

Identifier Source: org_study_id

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