NCT01558141

Brief Summary

Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy, which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm insemination, embryo culture and embryo transfer. The oocytes are removed during surgery by aspirating the follicles using a single lumen needle with an ultrasound to guide the procedure. There is some data that flushing the follicles with embryo culture media before aspiration using a double lumen needle increases the number of oocytes retrieved, particularly among poor responding patients for whom each additional oocyte recovered may substantially alter the outcome of that IVF cycle. The objective of the research is to evaluate the effect of follicular flushing in poor responders on IVF cycle outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

January 14, 2019

Status Verified

June 1, 2015

Enrollment Period

1.7 years

First QC Date

February 16, 2012

Last Update Submit

January 10, 2019

Conditions

Fertilization

Keywords

IVF stimulation.Poor responders.IVF patients with poor response to stimulation

Outcome Measures

Primary Outcomes (1)

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    To evaluate the number of oocytes retrieved with follicular flushing in poor responders

    2 weeks

Secondary Outcomes (8)

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    2 weeks

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    2 weeks

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    2 weeks

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    2 weeks

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    2 weeks

  • +3 more secondary outcomes

Study Arms (1)

Follicular flushing

ACTIVE COMPARATOR

Flushing follicles with embryo culture media prior to aspiration.

Other: Aspiration without flushing follicles with culture mediaOther: Follicular Flushing

Interventions

Aspiration without flushing follicles with culture mediaOTHER

Aspiration without flushing follicles with culture media.

Follicular flushing
Follicular FlushingOTHER

Flushing follicles with embryo culture media prior to aspiration.

Follicular flushing

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pts ages 18-45 undergoing IVF
  • Pts with ≤ 4 follicles that are ≥ 12mm on day of HCG

You may not qualify if:

  • Pts undergoing natural cycles (i.e. those with intentionally low # of follicles)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Related Publications (1)

  • Mok-Lin E, Brauer AA, Schattman G, Zaninovic N, Rosenwaks Z, Spandorfer S. Follicular flushing and in vitro fertilization outcomes in the poorest responders: a randomized controlled trial. Hum Reprod. 2013 Nov;28(11):2990-5. doi: 10.1093/humrep/det350. Epub 2013 Sep 5.

    PMID: 24014603DERIVED

MeSH Terms

Interventions

Culture Media

Intervention Hierarchy (Ancestors)

Laboratory ChemicalsSpecialty Uses of ChemicalsChemical Actions and UsesEquipment and Supplies

Study Officials

  • Steven D. Spandorfer, MD

    Weill Medical College of Cornell

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 16, 2012

First Posted

March 20, 2012

Study Start

September 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 14, 2019

Record last verified: 2015-06

Locations

US(1)