The Effect of Endometrial Scratching by Pipelle on the Pregnancy Rate in Couples With Unexplained Infertility

Abstract

The objective of this pilot randomized controlled trial was to test the effect of endometrial injury on pregnancy rate on day (21-26) of spontaneous menestual cycle in women with unexplained infertility aged between 20-35 years. An endometrial biopsy induced injury could produce a local inflammatory reactions and angiogenic environment between the endometrium and the conceptus which, in turn, facilitates embryo implantation and subsequent pregnancy in earlier studies. The study was conducted at the infertility out-patient clinic of Ain Shams University Maternity Hospital during the period from October 2013 to October 2014. In this randomized controlled study, 240 subjects were enrolled in the trial and 207 completed the study, they divided into 3 groups control group and study group that divided into Pipelle group and sound group: Group (A) (control group) consists of 60 patients without any intervention. Group (B) (Pipelle group) consists of 75 patients received endometrial injury on day 21-26 by Pipelle. Group (C) (sound group) consists of 72 patients without endometrial injury by introduction of sound only. All patients from the three groups were received combiened oral contraceptive pills that contain norgestimate 0.25mg, ethinyl oestradiol 0.35mg (Cilest®, Janssen,Cairo,Egypt) at the third day of the same cycle of intervention for twenty one days and were followed for six months for incidence of pregnancy. In group (A) patients had no any intervention and were followed for six months. In group (B) a single induced endometrial injury at the luteal phase on day (21-26) of the cycle was done by using Pipelle which introduced into the uterine cavity till the fundus and one sample was taken from posterior endometrium. In group (C) the uterine sound was introduced into the uterine cavity without endometrial injury at the same time. Couples were advised to practice sexual intercourse according to their convenience for the next 6 months. As regarding the demographic data of the patients in the present study, there were no statistical significant differences between women in the interventional group (Pipelle & sound) and control group as regard the mean age, BMI, duration of infertility, FSH, LH, E2 and incidence of pregnancy (P>0.05), also no demographic differences between women who got pregnant in Pipelle , sound and control group except regarding the mean age (P< 0.05). The rate of biochemical pregnancy was significantly higher in women subjected to endometrial injury by Pipelle (22/75) compared with non endometrial injury by sound (7/72) and control group (5/60) [29.3% vs.9.7% and 8.3% respectively P- value = 0.001] and no significant differences between the three groups as regard the time of pregnancy P>0.05. The rate of biochemical pregnancy in the interventional group (Pipelle & sound) was significantly higher than control group {19.7% vs 8.3%} , (p<0.05=0.045). Also the present study found that endometrial injury using the pipelle and duration of infertility were the only independent predictors of pregnancy and the number of patients needed to be treated in order to benefit a single patient was 8.8 (NNT = 8.8).