Effect of Endometrial Injury in Couples With Unexplained Infertility

January 8, 2018 updated by: Ahmed Maged, Cairo University

Comparative Study of Pregnancy Rate After Endometrial Injury in Couples With Unexplained Infertility

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12151
        • Kasr Alainy Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Clomiphene Citrate
50 mg twice daily from3rd day of cycle till 7th day of cycle
Other Names:
  • clomid
Drug: Human chorionic gonadotropin
75 IU dail;y from 6th day of cycle till 8th of cycle once daily
Other Names:
  • MerionaL
Device: 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
Active Comparator: Non scratch group
They will receive the same induction of ovulation as first group but without performing endometrial injury in preovulatory day
Drug: Clomiphene Citrate
50 mg twice daily from3rd day of cycle till 7th day of cycle
Other Names:
  • clomid
Drug: Human chorionic gonadotropin
75 IU dail;y from 6th day of cycle till 8th of cycle once daily
Other Names:
  • MerionaL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: 4 weeks after missed period
intrauterine gestational sac
4 weeks after missed period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 8, 2018

First Posted (Actual)

January 16, 2018

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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