Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-01-06 @ 9:46 AM
Study NCT ID:
NCT03398993
Status:
UNKNOWN
Last Update Posted:
2018-01-16
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Endometrial Injury in Couples With Unexplained Infertility
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Comparative Study of Pregnancy Rate After Endometrial Injury in Couples With Unexplained Infertility
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: