NCT02128360

Brief Summary

The purpose of this study is to determine whether minimal ovarian stimulation for in vitro fertilization is superior to high dose stimulation. Number of mature eggs, number of embryos as well as pregnancy rates will be compared.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

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

March 23, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

March 23, 2014

Last Update Submit

November 19, 2014

Conditions

Infertility

Keywords

Low ovarian reservePoor responderInfertility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rates

    1 Year

Secondary Outcomes (2)

  • Number of High quality embryos

    1 year

  • Number of eggs retrieved

    1 year

Study Arms (2)

Minimal stimulation protocol

ACTIVE COMPARATOR

Low dose Letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the Letrozole at 150 units per day. GnRH antagonist to avoid premature LH surge will be introduced when one or more of the growing follicles reached approximately 14 mm in size

Drug: Letrozole, Gonadotropins

High dose protocol

ACTIVE COMPARATOR

High dose of gonadotropins (≥300 IU/day) starting from cycle day 3. GnRH antagonist will be introduced to avoid premature LH surge when one or more of the growing follicles will reach approximately 14 mm in size

Drug: Gonadotropins

Interventions

Letrozole, GonadotropinsDRUG
Minimal stimulation protocol
GonadotropinsDRUG
High dose protocol

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of poor responder to ovarian stimulation

You may not qualify if:

  • Patients undergoing pregestational diagnosis (PGD)
  • Patients using donor eggs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Infertility

Interventions

LetrozoleGonadotropins

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Shir Dar, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shir Dar, MD

CONTACT

dr.shirdar@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2014

First Posted

May 1, 2014

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

IL(1)