NCT01999959

Brief Summary

To demonstrate a possible beneficial impact of pertubation we designed a randomized prospective study, in which uterine washing was administered prior to insemination in patients diagnosed with unexplained infertility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

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

January 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
Last Updated

December 3, 2013

Status Verified

November 1, 2013

Enrollment Period

1.2 years

First QC Date

November 26, 2013

Last Update Submit

November 26, 2013

Conditions

InfertilityPertubationInsemination

Keywords

Unexplained Infertility, Pertubation, Gonadotrophin, Ovulation Induction, Intrauterine Insemination

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    Pregnancy rate at 6 month-follow-up

    6 months

Study Arms (2)

Pertubation performed

EXPERIMENTAL

Study group had pertubation and insemination

Procedure: Pertubation

Pertubation not performed

NO INTERVENTION

Study group had insemination only

Interventions

PertubationPROCEDURE

a lavage procedure of the intrauterine cavity and bilateral fallopian tubes

Pertubation performed

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age of 18-44 years; presence of regular menstrual cycles and ovulation; absence of tubal occlusion on HSG; sperm concentration \>15 million spermatozoa/ml and total sperm number \>39 million/ml according to WHO criteria

You may not qualify if:

  • the presence of endocrinologic disease; use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids; clinical findings suggestive of pelvic inflammatory disease; and the presence of undiagnosed uterine bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Hospital

Ankara, Cankaya, Turkey (Türkiye)

Location

Related Publications (1)

  • Yildiz F, Bozkurt N, Erdem A, Erdem M, Oktem M, Onur Karabacak R. Effect of Pertubation on Pregnancy Rates before Intrauterine Insemination Treatment in Patients with Unexplained Infertility. Int J Fertil Steril. 2014 Apr;8(1):77-84. Epub 2014 Mar 9.

    PMID: 24695882DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 3, 2013

Study Start

January 1, 2010

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

December 3, 2013

Record last verified: 2013-11

Locations

TU(1)