NCT00490308

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

June 26, 2007

Status Verified

June 1, 2007

First QC Date

June 20, 2007

Last Update Submit

June 24, 2007

Conditions

Keywords

lutealphaseestradiolpregnancyrate

Outcome Measures

Secondary Outcomes (1)

  • E2 and progesterone levels

Interventions

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women treated for infertility with controlled ovarian hyperstimulation using daily GnRH agonist

You may not qualify if:

  • Women younger then 18 or older then 40
  • Women with systemic disease
  • Women with a family or personal history of thromboembolic event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infertilty unit, Assaf-Harofeh Medical Center

Ẕerifin, Israel

Location

MeSH Terms

Conditions

Infertility

Interventions

TherapeuticsEstradiol

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Rephael Ron-el, profesor

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ran Svirsky, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 22, 2007

Study Start

August 1, 2007

Study Completion

August 1, 2008

Last Updated

June 26, 2007

Record last verified: 2007-06

Locations