NCT02542280

Brief Summary

The investigator suggests that local endometrial injury using pipelle catheter performed in the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy rates among patients undergoing intrauterine insemination.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2013

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

July 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

January 8, 2016

Completed
Last Updated

January 8, 2016

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

September 3, 2015

Results QC Date

October 2, 2015

Last Update Submit

December 3, 2015

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

  • Chemical Pregnancy Rate

    Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.

    two weeks after intrauterine insemination

  • Clinical Pregnancy Rate

    Ultrasound detection of an intrauterine positive fetal heart pulsations

    six weeks

Study Arms (2)

endometrial injury

EXPERIMENTAL

Endometrial injury during ovarian stimulation combined with intrauterine insemination.

Procedure: endometrial injury.Procedure: intrauterine inseminationDrug: ovarian stimulation

no endometrial injury

ACTIVE COMPARATOR

Ovarian stimulation combined with intrauterine insemination.

Procedure: intrauterine inseminationDrug: ovarian stimulation

Interventions

endometrial injury.PROCEDURE

Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.

Also known as: endometrial scratch., endometrial sample.
endometrial injury
intrauterine inseminationPROCEDURE

Placement of washed sperm in the uterus using a catheter, around the time of ovulation.

Also known as: artificial insemination
endometrial injuryno endometrial injury
ovarian stimulationDRUG

Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.

Also known as: controlled ovarian hyperstimulatiom
endometrial injuryno endometrial injury

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years.
  • patent fallopian tunes.
  • mild male factor.
  • anovulation.
  • unexplained infertility.

You may not qualify if:

  • indications for ICSI.
  • evidence of pelvic inflammatory disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Interventions

Insemination, ArtificialOvulation Induction

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative TechniquesInseminationReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Results Point of Contact

Title
Ahmed Bahaa
Organization
Ain Shams Maternity Hospital
abahaa0503@yahoo.com
+20 1111700556

Study Officials

  • Ahmed Bahaa

    Lecturer in Obstetrics and Gynecology, faculty of medicine, Ain Shams University.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lesturer in Obstetrics and Gynecology.

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 7, 2015

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

January 8, 2016

Results First Posted

January 8, 2016

Record last verified: 2015-11