NCT01513954

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

January 17, 2012

Last Update Submit

January 17, 2012

Conditions

Infertility, Female

Keywords

Infertility

Study Arms (2)

IVF population

Long Lupron IVF Population

IUI patients

Patients undergoing IUI

Eligibility Criteria

Age21 Years - 37 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

IUI patients and IVF patients following a long lupron protocol cycle

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Red Rock Fertility Center

Las Vegas, Nevada, 89148, United States

RECRUITING

MeSH Terms

Conditions

Infertility, FemaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Eva D Littman, M.D.

    Red Rock Fertility Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva D Littman, M.D.

CONTACT

702-262-0079drevalittman@hotmail.com

Maria (Charry) R Lopez, M.D.

CONTACT

702-262-0079charry@lasvegasfertility.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 20, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

US(1)