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The Influence of Estradiol Supplementation During the Luteal in Patients Undergoing IVF Treatment

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Treatment with estradiol valerate
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring luteal, phase, estradiol, pregnancy, rate

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women treated for infertility with controlled ovarian hyperstimulation using daily GnRH agonist

Exclusion Criteria:

  • Women younger then 18 or older then 40
  • Women with systemic disease
  • Women with a family or personal history of thromboembolic event

Sites / Locations

  • Infertilty unit, Assaf-Harofeh Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

E2 and progesterone levels

Full Information

First Posted
June 20, 2007
Last Updated
June 24, 2007
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00490308
Brief Title
The Influence of Estradiol Supplementation During the Luteal in Patients Undergoing IVF Treatment
Official Title
Blinded Randomised Trial About the Influence of Estradiol Supplementation During the Luteal in Patients Undergoing in Vitro Fertilization (IVF) Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
luteal, phase, estradiol, pregnancy, rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Treatment with estradiol valerate
Secondary Outcome Measure Information:
Title
E2 and progesterone levels

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women treated for infertility with controlled ovarian hyperstimulation using daily GnRH agonist Exclusion Criteria: Women younger then 18 or older then 40 Women with systemic disease Women with a family or personal history of thromboembolic event
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Svirsky, MD
Phone
+972-0523-859521
Email
rsvirs@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rephael Ron-el, profesor
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infertilty unit, Assaf-Harofeh Medical Center
City
Zerifin
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ran svirsky, MD
First Name & Middle Initial & Last Name & Degree
mori shecter, MD

12. IPD Sharing Statement

Learn more about this trial

The Influence of Estradiol Supplementation During the Luteal in Patients Undergoing IVF Treatment

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