PregnancyQD vs BIDNCT00740025
Once Daily vs Twice Daily Administration of Gonadotropins in Assisted Reproductive Technologies (ART)
An observational study of Pregnancy, run by Virginia Center for Reproductive Medicine at 1 site in United States.
Trial summary
This is a prospective randomized study evaluating dosing frequency of gonadotropin administration in ART cycles. Read more about this study
- Who is it for?
- Ages 21 to 39 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 2010
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Study population: Women between 21-40 yo
Who may be able to join
- women < 40 undergoing ART
Who cannot join
- women > 40
- endometriomas
- severe cervical stenosis
- testicular sperm
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 Study of QD vs BID Dosing in ART
This is a prospective randomized study evaluating dosing frequency of gonadotropin administration in ART cycles.
Read the detailed description
Using once daily or bid dosing of gonadotropins in ART has been arbitrary with no studies showing whether splitting the medication dose improves ART parameters. This study was undertaken to provide an answer to this important question.
- Conditions
- Pregnancy
- Keywords
- QD dose, BID dosing, peak estradiol, oocytes, implantation rate, pregnancy rate
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 |
|---|---|---|
| QD | Women who received their meds as QD administration | |
| BID | Women who received their gonadotropins as a BID dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy
Measured: 1 year
Secondary outcomes (1)
peak estradiol, number of follicles, number of oocytes, implantation rate, multiple pregnancy rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startJan 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Center for Reproductive Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Fady I Sharara, M.D, Principal investigator, Virginia Center for Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740025
- Sponsor's protocol ID
- 1-Sharara
- Acronym
- QD vs BID
- Status last verified
- Oct 2010
- First submitted
- 21 Aug 2008
- Last updated
- 14 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of QD vs BID Dosing in ART
- ClinicalTrials.gov ID
- NCT00740025
- Acronym / sponsor ID
- QD vs BID / 1-Sharara
- Conditions
- Pregnancy
- Keywords
- QD dose, BID dosing, peak estradiol, oocytes, implantation rate, pregnancy rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Virginia Center for Reproductive MedicineUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 22 Aug 2008 (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 study evaluating dosing frequency of gonadotropin administration in ART cycles.
Detailed description
Using once daily or bid dosing of gonadotropins in ART has been arbitrary with no studies showing whether splitting the medication dose improves ART parameters. This study was undertaken to provide an answer to this important question.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QD | – | –Women who received their meds as QD administration |
| BID | – | –Women who received their gonadotropins as a BID dose |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women between 21-40 yo
Key inclusion criteria (1 listed)
- women < 40 undergoing ART
Key exclusion criteria (4 listed)
- women > 40
- endometriomas
- severe cervical stenosis
- testicular sperm
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
Ongoing pregnancy
Time frame: 1 year
1 secondary outcome
peak estradiol, number of follicles, number of oocytes, implantation rate, multiple pregnancy rate
Time frame: 1 year
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 14 Oct 2010.
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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.
Fady I Sharara, M.D principal investigator
Virginia Center for Reproductive Medicine
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 Pregnancy, 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 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: finished, as of the sponsor's last update on 14 Oct 2010. 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?
Ongoing pregnancy (time frame: 1 year). 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 14 Oct 2010.