Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National and Kapodistrian University of Athens.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
National and Kapodistrian University of Athens
Information provided by:
National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier:
NCT01315093
First received: March 8, 2011
Last updated: March 14, 2011
Last verified: November 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 8, 2011 | ||||
| Last Updated Date | March 14, 2011 | ||||
| Start Date ICMJE | November 2010 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Οngoing pregnancy rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] The presence of fetal heart on ultrasound after 12 weeks of gestation |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01315093 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Evidence and rate of clinical pregnancy [ Time Frame: 6+2 gestational weeks ] [ Designated as safety issue: No ] Presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks |
||||
| 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 | Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF) |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
||||
| Condition ICMJE | Infertility | ||||
| Intervention ICMJE | Drug: Heparin, Low-Molecular-Weight | ||||
| Study Arm (s) | Experimental: Heparin
Intervention: Drug: Heparin, Low-Molecular-Weight |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | December 2011 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 25 Years to 43 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Greece | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01315093 | ||||
| Other Study ID Numbers ICMJE | 123456 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National and Kapodistrian University of Athens | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | National and Kapodistrian University of Athens | ||||
| Verification Date | November 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||