Infertility, FemaleNCT01513954
Examination of Serum Progesterone Levels in an IVF Population Following Two Types of Egg Aspiration
An observational study of Infertility, Female, run by Red Rock Fertility Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: IUI patients and IVF patients following a long lupron protocol cycle
Who may be able to join
- Ages between 21-37
- Cycle Day 3 FSH between 2-12
- History of regular menstrual cycles between 24-34 days
Who cannot join
- Previous IVF failure
- Severe male factor
- Severe obesity, BMI > 40
- More than 20 follicles on ultrasound prior to retrieval
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Red Rock Fertility Center
Las Vegas, Nevada, 89148
Maria (Charry) R Lopez, MD, 702-262-0079, charry@lasvegasfertility.com
Eva D Littman, MD, 702-262-0079, drevalittman@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Infertility, Female
- Keywords
- Infertility
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IVF population | Long Lupron IVF Population | |
| IUI patients | Patients undergoing IUI |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Red Rock Fertility Center
- Sponsor type
- University, hospital or other
- Collaborators
- Watson Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Eva D Littman, M.D., Principal investigator, Red Rock Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513954
- Sponsor's protocol ID
- 20111821
- Status last verified
- Jan 2012
- First submitted
- 17 Jan 2012
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Serum Progesterone Levels in an IVF Population Following Two Types of Egg Aspiration
- ClinicalTrials.gov ID
- NCT01513954
- Acronym / sponsor ID
- 20111821
- Conditions
- Infertility, Female
- Keywords
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Red Rock Fertility CenterUniversity, hospital or other
- Collaborators
- Watson Pharmaceuticals
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVF population | – | –Long Lupron IVF Population |
| IUI patients | – | –Patients undergoing IUI |
Who may qualify
- Ages
- 21 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- IUI patients and IVF patients following a long lupron protocol cycle
Key inclusion criteria (3 listed)
- Ages between 21-37
- Cycle Day 3 FSH between 2-12
- History of regular menstrual cycles between 24-34 days
Key exclusion criteria (4 listed)
- Previous IVF failure
- Severe male factor
- Severe obesity, BMI > 40
- More than 20 follicles on ultrasound prior to retrieval
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva D Littman, M.D. principal investigator
Red Rock Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Red Rock Fertility Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva D Littman, M.D. (702-262-0079, drevalittman@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2012.