Effect of Endometrial Injury in Couples With Unexplained Infertility

• ClinicalTrials.gov Identifier: NCT03398993
• Recruitment Status: Unknown
• First Posted: January 16, 2018
• Last Update Posted: January 16, 2018
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ahmed Maged, Cairo University

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

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 Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

• Responsible Party: Ahmed Maged, professor, Cairo University
• ClinicalTrials.gov Identifier: NCT03398993
• Other Study ID Numbers: 17
• First Posted: January 16, 2018
• 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; Clomiphene; Enclomiphene; Zuclomiphene; Chorionic Gonadotropin; 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