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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00490308
First received: June 20, 2007
Last updated: June 24, 2007
Last verified: June 2007
  Purpose

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 Intervention Phase
Infertility
Drug: Treatment with estradiol valerate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Secondary Outcome Measures:
  • E2 and progesterone levels

Estimated Enrollment: 120
Study Start Date: August 2007
Estimated Study Completion Date: August 2008
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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00490308     History of Changes
Other Study ID Numbers: 870/070
Study First Received: June 20, 2007
Last Updated: June 24, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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 valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 21, 2014