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

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ClinicalTrials.gov Identifier: NCT00490308
Recruitment Status : Unknown
Verified June 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2007
Last Update Posted : June 26, 2007
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

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


Condition or disease Intervention/treatment Phase
Infertility Drug: Treatment with estradiol valerate Phase 1

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Blinded Randomised Trial About the Influence of Estradiol Supplementation During the Luteal in Patients Undergoing in Vitro Fertilization (IVF) Treatment
Study Start Date : August 2007
Estimated Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Secondary Outcome Measures :
  1. E2 and progesterone levels


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490308


Contacts
Contact: Ran Svirsky, MD +972-0523-859521 rsvirs@gmail.com

Locations
Israel
Infertilty unit, Assaf-Harofeh Medical Center Not yet recruiting
Zerifin, Israel
Sub-Investigator: ran svirsky, MD         
Sub-Investigator: mori shecter, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Rephael Ron-el, profesor Assaf-Harofeh Medical Center

ClinicalTrials.gov Identifier: NCT00490308     History of Changes
Other Study ID Numbers: 870/070
First Posted: June 22, 2007    Key Record Dates
Last Update Posted: June 26, 2007
Last Verified: June 2007

Keywords provided by Assaf-Harofeh Medical Center:
luteal
phase
estradiol
pregnancy
rate

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female