NCT02863198

Brief Summary

One hundred and twenty women with unexplained infertility were included in the study. Divided randomly into two groups: Group I: (60 patients): (control group) Group II (60 patients): (study group) All the patients received (CC) and human menopausal gonadotropin. On day 5 of the cycle, Doppler examination was performed to all patients. Also on day 5, but only for group (II) patients, local endometrial injury was performed. Doppler studies was repeated, for all our patients, on the same day of prescribing human chorionic gonadotropin

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

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

October 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 14, 2017

Completed
Last Updated

March 14, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

August 4, 2016

Results QC Date

September 1, 2016

Last Update Submit

January 24, 2017

Conditions

Infertility

Keywords

unexplained infertilityendometrial injurypregnancy

Outcome Measures

Primary Outcomes (5)

  • Measurement of Uterine Artery Pulsatility Index

    measurement of uterine artery pulsatility index at day of human chorionic gonadotropin administration.Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance.

    one week

  • Measurement of Uterine Artery Resistance Index

    measurement of uterine artery resistance index at day of human chorionic gonadotropin administration.it is an indicator of resistance of uterine artery to perfusion . In ultrasonography, it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity.lower values are better than higher values.

    one week

  • Appearance of Sub Endometrial Blood Flow in All Patients

    Appearance of sub endometrial blood flow between patients of study and control groups on the day of human chorionic gonadotropin administration. subendometrial blood flow distribution pattern was determined by demonstrating pulsatile color signals in the sub endometrial area.The number of patients demonstrating subendometrial blood flow distribution pattern are collected .

    one week

  • Spiral Artery Pulsatility Indices in All Patients

    Spiral artery Doppler pulsatility indices between study and control groups on the day of human chorionic gonadotropin administration.Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance

    one week

  • Spiral Artery Doppler Resistance Indices in All Patients

    Spiral artery Doppler resistance indices between study and control groups on the day of human chorionic gonadotropin administration.it is an indicator of resistance of Spiral artery to perfusion . In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity.lower values are better than higher values.

    one week

Secondary Outcomes (1)

  • Pregnancy Rate Between the Study and the Control Group

    3 weeks

Study Arms (2)

endometrial injury

ACTIVE COMPARATOR

Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10-15 mm from the fundus using pipelle endometrial sampling (Pipelle).

Device: endometrial injury

non endometrial injury

NO INTERVENTION

non endometrial injury was done only for patient of the control group

Interventions

endometrial injuryDEVICE

Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10-15 mm from the fundus using pipelle endometrial sampling (Pipelle).

endometrial injury

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age Between 20 - 35 years
  • Body mass index 18-29 kg/m2
  • primary infertility for more than two years, and planning for IVF/intracytoplasmic sperm injection trial
  • Normal ovulation confirmed by previous US
  • Normal hormonal profile follicle stimulating hormone, luteinizing hormone, and prolactin, Antimullerian hormone (AMH) more than 1 ng/ml
  • Normal hysterosalpingography
  • Normal laparoscopic finding
  • normal semen analysis, according to World Health Organization 2010

You may not qualify if:

  • History of previous laparotomy
  • Patients with history which may suggest endometriosis
  • Associated chronic medical conditions e.g. cardiac disease, diabetes, renal disease… etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha university hospitalا

Banhā, Alqalubia, Egypt

Location

Related Publications (1)

  • Maged AM, Al-Inany H, Salama KM, Souidan II, Abo Ragab HM, Elnassery N. Endometrial Scratch Injury Induces Higher Pregnancy Rate for Women With Unexplained Infertility Undergoing IUI With Ovarian Stimulation: A Randomized Controlled Trial. Reprod Sci. 2016 Feb;23(2):239-43. doi: 10.1177/1933719115602776. Epub 2015 Sep 3.

    PMID: 26342054BACKGROUND

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Limitations and Caveats

No limitation or caveats

Results Point of Contact

Title
dr khalid M Salama
Organization
Benha university
dr.khalid_sleem@yahoo.com
01225861026

Study Officials

  • khalid M salama

    Benha University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director clinical research

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 11, 2016

Study Start

October 1, 2013

Primary Completion

February 1, 2016

Study Completion

July 1, 2016

Last Updated

March 14, 2017

Results First Posted

March 14, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)