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Endometrial Injury for Unexplained Infertility

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
endometrial injury
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring unexplained infertility, endometrial injury, pregnancy

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Benha university hospitalا

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

endometrial injury

non endometrial injury

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.
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.
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 .
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
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.

Secondary Outcome Measures

Pregnancy Rate Between the Study and the Control Group
detection of serum pregnancy tests for both groups( study and the control group)

Full Information

First Posted
August 4, 2016
Last Updated
January 24, 2017
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT02863198
Brief Title
Endometrial Injury for Unexplained Infertility
Official Title
Endometrial Injury for Unexplained Infertility: Randomized Case-control Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
This randomized case-control study was performed at the Obstetrics and Gynecology Department of University Hospital, during the period between October 2013 till July 2015. One hundred and twenty women with unexplained infertility were included in the study. Written, informed, consent, was taken from all women after explaining the nature and the aim of the study. The 120 patients were divided randomly into two groups (based on each alternate week referral to the clinic). All the patients received Clomiphene citrate (CC) and, Human menopausal gonadotrophin, according to the following protocol: Clomiphene Citrate (Clomiphene tablets, Clomiphene citrate 50 mg), 100 mg/day for 5 consecutive days, with therapy initiated on cycle day 3. Human menopausal gonadotrophin (Merional 75 international unit), was injected intra-muscularly, in a dose of 150 iu/day, on the days 3, 5, 7, 9 of the menstrual cycle. Serial transvaginal ultra sound was performed for all patients starting from day 10 and repeated every other day. Human menopausal gonadotrophin was continued daily, in the same dose, until follicles reached 18-22 mm. When the dominant follicles reached 18-22 mm, as measured by transvaginal ultrasound, human chorionic gonadotropin (5000 international unit) was injected intramuscularly, in a dose of 5,000 - 10,000 IU, and timed intercourse was advised, 36 h after human chorionic gonadotropin injection and the days after. Vaginal ultrasound was done about 60 h after human chorionic gonadotropin injection to confirm follicular rupture. 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. Technique of trans vaginal ultrasound: Trans vaginal sonography examination was performed with patient in the lithotomy position using transvaginal transducer with color Doppler facility, a longitudinal view of the uterus was obtained then, the color Doppler mode was activated. The endometrial and subendometrial blood flow distribution pattern was determined by demonstrating pulsatile color signals in the sub endometrial and endometrial regions. Doppler sonography was performed on the vessels with the highest color intensity within the innermost endometrial and sub endometrial area. The insonation angle was kept at 0° to identify the course of the small spiral arteries. After confirming that waveforms were continuous, an average of three to five cardiac cycles were selected for calculation of resistance index (RI), pulsatility index (PI). The vessel with the lowest PI was considered for further statistical analysis. Uterine circulation was assessed simultaneously in each examination; bilateral uterine arteries were sampled lateral to the cervix near the internal os. Mean levels of both uterine RI and PI were used for analysis.on the day of human chorionic gonadotropin administration the endometrial thickness was measured, and reported. on the same day The endometrial pattern was evaluated and described as a multilayered or a non-multilayered endometrium. A trilaminar endometrium presented as a triple-line pattern in which hyperechogenic outer lines and a well-defined central echogenic line with hypoechogenic or black areas between these lines. A non trilaminar endometrium consisted of homogeneous endometrial patterns, characterized by either hyperechogenic or isoechoic endometrium. Technique of endometrial injury: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
unexplained infertility, endometrial injury, pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endometrial injury
Arm Type
Active Comparator
Arm Description
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).
Arm Title
non endometrial injury
Arm Type
No Intervention
Arm Description
non endometrial injury was done only for patient of the control group
Intervention Type
Device
Intervention Name(s)
endometrial injury
Intervention Description
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).
Primary Outcome Measure Information:
Title
Measurement of Uterine Artery Pulsatility Index
Description
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.
Time Frame
one week
Title
Measurement of Uterine Artery Resistance Index
Description
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.
Time Frame
one week
Title
Appearance of Sub Endometrial Blood Flow in All Patients
Description
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 .
Time Frame
one week
Title
Spiral Artery Pulsatility Indices in All Patients
Description
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
Time Frame
one week
Title
Spiral Artery Doppler Resistance Indices in All Patients
Description
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.
Time Frame
one week
Secondary Outcome Measure Information:
Title
Pregnancy Rate Between the Study and the Control Group
Description
detection of serum pregnancy tests for both groups( study and the control group)
Time Frame
3 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Absence of inclusion criteria History of previous laparotomy Patients with history which may suggest endometriosis Associated chronic medical conditions e.g. cardiac disease, diabetes, renal disease… etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khalid M salama
Organizational Affiliation
Benha University
Official's Role
Study Director
Facility Information:
Facility Name
Benha university hospitalا
City
Benha
State/Province
Alqalubia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26342054
Citation
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.
Results Reference
background
Links:
URL
http://bu.edu.eg
Description
infertility

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Endometrial Injury for Unexplained Infertility

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