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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00490308
• Other study ID #: 870/070
• Status: Not yet recruiting
• Phase: Phase 1
• First received: June 20, 2007
• Last updated: June 24, 2007
• Start date: August 2007
• Est. completion date: August 2008

Study information

• Verified date: June 2007
• Source: Assaf-Harofeh Medical Center
• Contact: Ran Svirsky, MD
• Phone: +972-0523-859521
• Email: rsvirs[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Treatment with estradiol valerate

Locations

Country	Name	City	State
Israel	Infertilty unit, Assaf-Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	E2 and progesterone levels