Once Daily vs Twice Daily Administration of Gonadotropins in Assisted Reproductive Technologies (ART) (QD vs BID)
This study has been completed.
Sponsor:
Virginia Center for Reproductive Medicine
Information provided by:
Virginia Center for Reproductive Medicine
ClinicalTrials.gov Identifier:
NCT00740025
First received: August 21, 2008
Last updated: October 12, 2010
Last verified: October 2010
| Tracking Information | |||||
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| First Received Date ICMJE | August 21, 2008 | ||||
| Last Updated Date | October 12, 2010 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Ongoing pregnancy [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00740025 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
peak estradiol, number of follicles, number of oocytes, implantation rate, multiple pregnancy rate [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Once Daily vs Twice Daily Administration of Gonadotropins in Assisted Reproductive Technologies (ART) | ||||
| Official Title ICMJE | A Prospective Randomized Study of QD vs BID Dosing in ART | ||||
| Brief Summary | This is a prospective randomized study evaluating dosing frequency of gonadotropin administration in ART cycles. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Women between 21-40 yo |
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| Condition ICMJE | Pregnancy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | January 2010 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 21 Years to 39 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00740025 | ||||
| Other Study ID Numbers ICMJE | 1-Sharara | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Fady I. Sharara, Virginia Center for Reproductive Medicine | ||||
| Study Sponsor ICMJE | Virginia Center for Reproductive Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Virginia Center for Reproductive Medicine | ||||
| Verification Date | October 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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