The Influence of Estradiol Supplementation During the Luteal in Patients Undergoing IVF Treatment
Information source: Assaf-Harofeh Medical Center
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: Treatment with estradiol valerate (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Assaf-Harofeh Medical Center Official(s) and/or principal investigator(s):
Rephael Ron-el, profesor, Principal Investigator, Affiliation: Assaf-Harofeh Medical Center
Overall contact:
Ran Svirsky, MD, Phone: +972-0523-859521, Email: rsvirs@gmail.com
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
Clinical Details
Official title: Blinded Randomised Trial About the Influence of Estradiol Supplementation During the Luteal in Patients Undergoing in Vitro Fertilization (IVF) Treatment
Study design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study
Secondary outcome: E2 and progesterone levels
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
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
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
Locations and Contacts
Ran Svirsky, MD, Phone: +972-0523-859521, Email: rsvirs@gmail.com
Infertilty unit, Assaf-Harofeh Medical Center, Zerifin, Israel
Additional Information
Starting date: August 2007
Ending date: August 2008
Last updated: June 24, 2007
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