InfertilityNCT01139593
A Trial Comparing Qam With Qpm Dosing in Assisted Reproductive Technologies (ART)
An observational study of Infertility, run by Virginia Center for Reproductive Medicine at 1 site in United States.
Trial summary
This is a prospective randomized trial comparing the outcome in women undergoing IVF/ICSI when taking their gonadotropin dosage in the morning (am) or evening (pm). Read more about this study
- Who is it for?
- Ages 21 to 42 years, women only
- Conditions the study is for
- Infertility
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2015
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile women between 21 and 44 years old
Who may be able to join
- women between 21-42 undergoing IVF
Who cannot join
- women > 45,
- women with one ovary,
- donor egg,
- surrogacy,
- FET cycles,
- uterine problems,
- large fibroids
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Center for Reproductive Medicine
Reston, Virginia, 20190
About this study
Official title: A Prospective Randomized Trial Comparing Qam With Qpm Daily Dosing in Assisted Reproductive Technologies
This is a prospective randomized trial comparing the outcome in women undergoing IVF/ICSI when taking their gonadotropin dosage in the morning (am) or evening (pm).
- Conditions
- Infertility
- Keywords
- IVF, ICSI, gonadotropin, am dose, pm dose, pregnancy, implantation, live birth
- Medical subject headings
- 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 |
|---|---|---|
| morning dose | women undergoing IVF/ICSi taking their gonadotropin dose in the am | |
| evening dose | Women undergoing IVF/ICSI taking their gonadotropin in the evening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Center for Reproductive Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fady I. Sharara, M.D, Virginia Center for Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139593
- Sponsor's protocol ID
- VCRM 5
- Status last verified
- Dec 2015
- First submitted
- 6 Jun 2010
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Qam With Qpm Daily Dosing in Assisted Reproductive Technologies
- ClinicalTrials.gov ID
- NCT01139593
- Acronym / sponsor ID
- VCRM 5
- Conditions
- Infertility
- Keywords
- IVF, ICSI, gonadotropin, am dose, pm dose, pregnancy, implantation, live birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Virginia Center for Reproductive MedicineUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Jun 2010 (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.
This is a prospective randomized trial comparing the outcome in women undergoing IVF/ICSI when taking their gonadotropin dosage in the morning (am) or evening (pm).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morning dose | – | –women undergoing IVF/ICSi taking their gonadotropin dose in the am |
| evening dose | – | –Women undergoing IVF/ICSI taking their gonadotropin in the evening |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women between 21 and 44 years old
Key inclusion criteria (1 listed)
- women between 21-42 undergoing IVF
Key exclusion criteria (7 listed)
- women > 45,
- women with one ovary,
- donor egg,
- surrogacy,
- FET cycles,
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
Live birth rate
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Virginia Center for Reproductive Medicine 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 9 Dec 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: 4 years). It is what the study was designed to measure, not a finding.
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 9 Dec 2015.