Effect of Endometrial Injury in Couples With Unexplained Infertility
NCT ID: NCT03398993
Last Updated: 2018-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-01-31
2018-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Scratch group
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
Clomiphene Citrate
50 mg twice daily from3rd day of cycle till 7th day of cycle
Human chorionic gonadotropin
75 IU dail;y from 6th day of cycle till 8th of cycle once daily
Endometrial scratch
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
Non scratch group
They will receive the same induction of ovulation as first group but without performing endometrial injury in preovulatory day
Clomiphene Citrate
50 mg twice daily from3rd day of cycle till 7th day of cycle
Human chorionic gonadotropin
75 IU dail;y from 6th day of cycle till 8th of cycle once daily
Interventions
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Clomiphene Citrate
50 mg twice daily from3rd day of cycle till 7th day of cycle
Human chorionic gonadotropin
75 IU dail;y from 6th day of cycle till 8th of cycle once daily
Endometrial scratch
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Abnormal HSG.
* Abnormal laparoscopic findings.
* Disturbed hormonal profile.
* Evidence of cervical factor.
* Known genetic disorder
* Known autoimmune disease
20 Years
36 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Maged
professor
Principal Investigators
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Ahmed Maged
Role: PRINCIPAL_INVESTIGATOR
Professor
Locations
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Kasr Alainy medical school
Cairo, , Egypt
Countries
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Central Contacts
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Other Identifiers
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17
Identifier Type: -
Identifier Source: org_study_id
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