The Need for Luteal Support in NC-FET
This study is not yet open for participant recruitment.
Verified November 2011 by Wolfson Medical Center
Sponsor:
Wolfson Medical Center
Information provided by (Responsible Party):
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01483365
First received: November 29, 2011
Last updated: December 6, 2011
Last verified: November 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 29, 2011 | ||||
| Last Updated Date | December 6, 2011 | ||||
| Start Date ICMJE | December 2011 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pregnancy rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] We would like to investigate whether there is need for luteal support in NC-FET cycle. |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01483365 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Need for Luteal Support in NC-FET | ||||
| Official Title ICMJE | The Use of Luteal Support After NC-FET | ||||
| Brief Summary | The investigators are going to examine prospectively the need of luteal support after NC-FET. |
||||
| Detailed Description | The investigators are going to examine retroprospectively the need of luteal support after NC-FET in IVF cycle. One arm will receive luteal support after NC FET with vaginal tablet of Endometrin 100 mg twice a day after ET. The second arm will not. We are going to evaluate the pregnancy and implantation rate. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
||||
| Condition ICMJE | Abnormal Menstrual Cycle | ||||
| Intervention ICMJE | Drug: Vaginal tablet Endometrin twice a day
Endometrin 100 mg twice a day
Other Name: Endometrin 100 mg twice a day |
||||
| Study Arm (s) | Not Provided | ||||
| 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 | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 18 Years to 39 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01483365 | ||||
| Other Study ID Numbers ICMJE | 0087-11-WOMC- | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Wolfson Medical Center | ||||
| Study Sponsor ICMJE | Wolfson Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Wolfson Medical Center | ||||
| Verification Date | November 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||