Effect of Endometrial Injury in Couples With Unexplained Infertility

What Was Tested

The trial (not phased) is built around hCG (human chorionic gonadotropin) for endometriosis.

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.

It had two arms (groups): Scratch group (active comparator) and Non scratch group (active comparator).

They will receive the same induction of ovulation as first group but without performing endometrial injury in preovulatory day.

The registry classes the interventions as device and drug.

More on the Plan

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.

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.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to women only aged from 20 years up to 36 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Unexplained infertility ( 1ry \& 2ndry infertility) : \*. Normal hormonal profile of infertile woman. Normal investigation of the cervical factor. Fertile semen analysis (according to world health organization criteria 2015).

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: • infertile semen analysis; abnormal hsg; abnormal laparoscopic findings.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The endometriosis participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

It started in 2018-01 with completion listed for 2018-12.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): clinical pregnancy rate (time frame: 4 weeks after missed period).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 100 people with endometriosis.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, Endometriosis research.