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| Sponsor: | Assaf-Harofeh Medical Center |
|---|---|
| Information provided by: | Assaf-Harofeh Medical Center |
| ClinicalTrials.gov Identifier: | NCT00490308 |
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 I |
| 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 |
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2008 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ran Svirsky, MD | +972-0523-859521 | rsvirs@gmail.com |
| Israel | |
| Infertilty unit, Assaf-Harofeh Medical Center | Not yet recruiting |
| Zerifin, Israel | |
| Sub-Investigator: ran svirsky, MD | |
| Sub-Investigator: mori shecter, MD | |
| Principal Investigator: | Rephael Ron-el, profesor | Assaf-Harofeh Medical Center |
More Information
| 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 |
|
luteal phase estradiol pregnancy rate |
|
Infertility Genital Diseases, Male Genital Diseases, Female Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estradiol Polyestradiol phosphate Contraceptive Agents |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female |
