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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 20, 2007 | ||||
| Last Updated Date | June 24, 2007 | ||||
| Start Date ICMJE | August 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00490308 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
E2 and progesterone levels | ||||
| Original Secondary Outcome Measures ICMJE |
E2 and progesteron levels | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Influence of Estradiol Supplementation During the Luteal in Patients Undergoing IVF Treatment | ||||
| Official Title ICMJE | Blinded Randomised Trial About the Influence of Estradiol Supplementation During the Luteal in Patients Undergoing in Vitro Fertilization (IVF) Treatment | ||||
| Brief Summary | To evaluate whether treatment with Estradiol supplementation during the luteal phase improves IVF outcomes Patients undergoing IVF treatment with controlled ovarian hyperstimulation using a GnRH analog will receive 4 mg estradiol valerate in the luteal phase.Patient's followup will include E2 progesterone and BHCG 14 days after embryo transfer and vaginal ultrasound on day 21 and 28 after embryo transfer |
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| Detailed Description | The study will include Patients undergoing IVF treatment with controlled ovarian hyperstimulation using a daily GnRH analog in a long protocol,older then 18, .The women will be randomised to two groups.Both groups will be given vaginal tabs of natural micronized progesterone(Uterogestan) The study group will be given oral estradiol Valerate 4 mg.Prior to treatment, each patient will be signed on informed concent. Patients will be excluded if they are older than 40, have any systemic illnesses or a personal or family history of a thromboembolic event. Follow up: Verification of pregnancy status and hormonal profile will be carried out on day fourteen after embryo transfer by means of serum hCG,P and E2. clinical pregnancy will be defined as the presence of a gestational sac on ultrasonography on day 21 after embryo transfer and fetal heart will be evaluated on day 28 |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study | ||||
| Condition ICMJE | Infertility | ||||
| Intervention ICMJE | Drug: Treatment with estradiol valerate | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Estimated Completion Date | August 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00490308 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 870/070 | ||||
| Study Sponsor ICMJE | Assaf-Harofeh Medical Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Assaf-Harofeh Medical Center | ||||
| Verification Date | June 2007 | ||||
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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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