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Effect of Endometrial Injury in Couples With Unexplained Infertility

Primary Purpose

Unexplained Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Clomiphene Citrate
Human chorionic gonadotropin
Endometrial scratch
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unexplained Infertility

Eligibility Criteria

20 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Unexplained infertility ( 1ry & 2ndry infertility) : *

    • Normal hormonal profile of infertile woman.
    • Normal hystrosalpingogram.
    • Normal laparoscopy.
    • Normal investigation of the cervical factor
    • Fertile semen analysis (according to world health organization criteria 2015).

Exclusion Criteria:

  • • Infertile semen analysis.

    • Abnormal HSG.
    • Abnormal laparoscopic findings.
    • Disturbed hormonal profile.
    • Evidence of cervical factor.
    • Known genetic disorder
    • Known autoimmune disease

Sites / Locations

  • Kasr Alainy medical school

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Scratch group

Non scratch group

Arm Description

Induction of ovulation will be done by clomophine citrate from 3rd day of cycle till 7th day of cycle and HMG 75IU (MerionaL) given from 6th day of cycle till 8th of cycle once daily. folliculometry done regularly during induction of ovulation till dominant follicle reached 18_20mm in size. Then endometrial injury performed in pre ovulatory day by a thin pipelle (a fine, flexible, sterile, plastic tube) The procedure was carried out in preovulatory day (known when dominant follicle reached 18_20 mm in diameter), usually, done around day 14-day of the cycle

They will receive the same induction of ovulation as first group but without performing endometrial injury in preovulatory day

Outcomes

Primary Outcome Measures

clinical pregnancy rate
intrauterine gestational sac

Secondary Outcome Measures

Full Information

First Posted
January 8, 2018
Last Updated
January 8, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03398993
Brief Title
Effect of Endometrial Injury in Couples With Unexplained Infertility
Official Title
Comparative Study of Pregnancy Rate After Endometrial Injury in Couples With Unexplained Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
100 patient of unexplained infertility recruited and divided into two groups for the study group (50) endometrial scratching done in preovulatory period after controlled ovarian stimulation by clomiphene citrate , then followed and compared to control group for 6 months to asses pregnancy rate
Detailed Description
Induction of ovulation was done by clomophine citrate (selective estrogen modulator of triphenylethylene group, produced by( Sanafi Aventis company) from 3rd day of cycle till 7th day of cycle and HMG 75IU (MerionaL) produced by IBSA ( Institute biochimique SA) given from 6th day of cycle till 8th of cycle once daily. folliculometry done regularly during induction of ovulation till dominant follicle reached 18_20mm in size. Then endometrial injury performed in pre ovulatory day by a thin pipelle (a fine, flexible, sterile, plastic tube) produced by Jiangsu Guard King Medical Equipment Co. The procedure was carried out in preovulatory day (known when dominant follicle reached 18_20 mm in diameter), usually, done around day 14-day of the cycle. In the theatre, Patients put in a lithotomy position, sterilization was performed with the presence of good source of light., the procedure was carried out using a thin pipelle tube as follow :- A cuscoe's speculum was inserted into the vagina in order to visualize the cervix. Cervix was grasped by vollselum upwards backwards, then pipelle tube passed through the cervix and uterine cavity, then moved up and down to make a single induced scratch two times in the lining endometrium of posterior wall of uterus. The procedure took approximately 15minutes to complete. It was uncomfortable or painful in some circumstances and that bleeding after the procedure happened in many cases. Post procedure antibiotics were given. Couples were advised to practice timed sexual intercourse for next 6months and couples in both groups were asked to phone a contact Person whenever there was a missed period. The patients followed up for six months for detecion of the biochemical pregnancy if occurred. 2- Control group (50patients) :- They received the same induction of ovulation as first group but without performing endometrial injury in preovulatory day. We wait till time of period if missed period achieved serum pregnancy test done after one week of missed period . All women followed for 6 months after treatment. Comparative study was done for both groups and results presented in tables and statistically analyzed

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unexplained Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scratch group
Arm Type
Active Comparator
Arm Description
Induction of ovulation will be done by clomophine citrate from 3rd day of cycle till 7th day of cycle and HMG 75IU (MerionaL) given from 6th day of cycle till 8th of cycle once daily. folliculometry done regularly during induction of ovulation till dominant follicle reached 18_20mm in size. Then endometrial injury performed in pre ovulatory day by a thin pipelle (a fine, flexible, sterile, plastic tube) The procedure was carried out in preovulatory day (known when dominant follicle reached 18_20 mm in diameter), usually, done around day 14-day of the cycle
Arm Title
Non scratch group
Arm Type
Active Comparator
Arm Description
They will receive the same induction of ovulation as first group but without performing endometrial injury in preovulatory day
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate
Other Intervention Name(s)
clomid
Intervention Description
50 mg twice daily from3rd day of cycle till 7th day of cycle
Intervention Type
Drug
Intervention Name(s)
Human chorionic gonadotropin
Other Intervention Name(s)
MerionaL
Intervention Description
75 IU dail;y from 6th day of cycle till 8th of cycle once daily
Intervention Type
Device
Intervention Name(s)
Endometrial scratch
Intervention Description
The procedure was carried out in preovulatory day (known when dominant follicle reached 18_20 mm in diameter), usually, done around day 14-day of the cycle. In the theatre, Patients put in a lithotomy position, sterilization was performed with the presence of good source of light., the procedure was carried out using a thin pipelle tube as follow :- A cuscoe's speculum was inserted into the vagina in order to visualize the cervix. Cervix was grasped by vollselum upwards backwards, then pipelle tube passed through the cervix and uterine cavity, then moved up and down to make a single induced scratch two times in the lining endometrium of posterior wall of uterus. The procedure took approximately 15minutes to complete
Primary Outcome Measure Information:
Title
clinical pregnancy rate
Description
intrauterine gestational sac
Time Frame
4 weeks after missed period

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unexplained infertility ( 1ry & 2ndry infertility) : * Normal hormonal profile of infertile woman. Normal hystrosalpingogram. Normal laparoscopy. Normal investigation of the cervical factor Fertile semen analysis (according to world health organization criteria 2015). Exclusion Criteria: • Infertile semen analysis. Abnormal HSG. Abnormal laparoscopic findings. Disturbed hormonal profile. Evidence of cervical factor. Known genetic disorder Known autoimmune disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed maged
Phone
+20201005227404
Email
dr_ahmedmaged08@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
ameer elsherief
Email
ameerelsherief@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Endometrial Injury in Couples With Unexplained Infertility

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