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Clinical Trials/NCT00490308
NCT00490308
Unknown
Phase 1

Blinded Randomised Trial About the Influence of Estradiol Supplementation During the Luteal in Patients Undergoing in Vitro Fertilization (IVF) Treatment

Assaf-Harofeh Medical Center1 site in 1 country120 target enrollmentAugust 2007

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Infertility
Sponsor
Assaf-Harofeh Medical Center
Enrollment
120
Locations
1
Last Updated
18 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
August 2008
Last Updated
18 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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