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Effect of Endometrial Injury in Couples With Unexplained Infertility

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ClinicalTrials.gov Identifier: NCT03398993
Recruitment Status : Not yet recruiting
First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

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

Condition or disease Intervention/treatment Phase
Unexplained Infertility Drug: Clomiphene Citrate Drug: Human chorionic gonadotropin Device: Endometrial scratch Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Pregnancy Rate After Endometrial Injury in Couples With Unexplained Infertility
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

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 Name: clomid
Drug: Human chorionic gonadotropin
75 IU dail;y from 6th day of cycle till 8th of cycle once daily
Other Name: 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 Name: clomid
Drug: Human chorionic gonadotropin
75 IU dail;y from 6th day of cycle till 8th of cycle once daily
Other Name: MerionaL



Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: 4 weeks after missed period ]
    intrauterine gestational sac



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Ages Eligible for Study:   20 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398993


Contacts
Contact: Ahmed maged +20201005227404 dr_ahmedmaged08@kasralainy.edu.eg
Contact: ameer elsherief ameerelsherief@yahoo.com

Locations
Egypt
Kasr Alainy medical school
Cairo, Egypt, 12151
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Ahmed Maged Professor

Responsible Party: Ahmed Maged, professor, Cairo University
ClinicalTrials.gov Identifier: NCT03398993     History of Changes
Other Study ID Numbers: 17
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Chorionic Gonadotropin
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators