NCT01419353

Brief Summary

The purpose of this study is to determine if pretreatment with Estrogen can assist in the planning and programming of In Vitro Fertilization treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 18, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 24, 2013

Status Verified

August 1, 2011

Enrollment Period

1.8 years

First QC Date

August 1, 2011

Last Update Submit

December 23, 2013

Conditions

Infertility

Keywords

Infertility, IVF, Estrogen

Outcome Measures

Primary Outcomes (1)

  • ovum pickup rate that took place between Sunday to Thursday without a compromise

    number of Pickups that took place between Sunday to Thursday (without a compromise in treatment) \\ by the entire pickup number

    a year

Secondary Outcomes (1)

  • pregnancy rate

    a year

Study Arms (2)

Follicular Estrogen, Antagonist, IVF

EXPERIMENTAL

Follicular Estrogen in Antagonist IVF protocol

Drug: estradiol valerate

long IVF protocol

ACTIVE COMPARATOR

long IVF protocol

Drug: estradiol valerate

Interventions

estradiol valerateDRUG

2 mg P.O / day for 1-6 days.

Follicular Estrogen, Antagonist, IVFlong IVF protocol

Eligibility Criteria

AgeUp to 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • IVF treatment in the following indications: Male, Mechanical, Unexplained
  • Age\<38 years
  • Treatment Cycle number 1-4

You may not qualify if:

  • Ovulatory disorder as an indication for IVF
  • Repeated failure in previous IVF treatments (\> than 4 cycles)
  • Sperm used for treatment was retrieved by surgical procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel, Israel

Location

Related Publications (1)

  • Hershko Klement A, Berkovitz A, Wiser A, Gonen O, Amichay K, Cohen I, Ghetler Y, Shulman A. GnRH-antagonist programming versus GnRH agonist protocol: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2015 Feb;185:170-3. doi: 10.1016/j.ejogrb.2014.12.021. Epub 2014 Dec 29.

    PMID: 25594526DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Adrian Shulman, MD

    Meir Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2011

First Posted

August 18, 2011

Study Start

August 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

December 24, 2013

Record last verified: 2011-08

Locations

IL(1)