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UnknownNCT02084914

Endometrial Scratching by Pipelle on Pregnancy Rate in Unexplained Infertility

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

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
158 (estimated)
Sponsor
Ain Shams University · Academic / Other
Sex
Female
Age
20 Years – 35 Years
Healthy volunteers
Not accepted

Summary

Research question: Population: women with unexplained infertility. Intervention: endometrial scratching by pipelle for women with unexplained infertility. Comparison: to compare with non endometrial scratching for women with unexplained infertility. Outcome: the biochemical pregnancy rate. Research hypothesis: Null hypothesis: there is no difference in the rate of pregnancy between scratching and non endometrial scratching in women with unexplained infertility. Alternative hypothesis: there is difference in the rate of pregnancy between scratching and non endometrial scratching in women with unexplained infertility.

Detailed description

Unexplained infertility (UI) is a term used to describe infertile couples in whom standard investigations, including semen analysis, tests of ovulation and tubal patency, have failed to detect any gross abnormality (Crosignani et al., 1993). It is a diagnosis of exclusion, almost 30-40% of infertile couples would suffer from this type of subfertility (Simth et al., 2003). A diversity of causes had been hypothesized to explain the condition. Cervical, uterine, ovulatory, peritoneal, immunological, endocrinological, genetic defects and reproductive physiology disturbances had been continuously suggested as potential causative factors (Rov et al., 2005; Shveiky et al., 2006; Bellver et al., 2008; Golubovsky, 2008; Woodson, 2008). Empirically, interventions for managing unexplained infertility had been widely practiced. These interventions include expectant management, intrauterine insemination (IUI) with ovarian stimulation and in vitro fertilization (El-Toukhy \& Khalaf, 2008; Bhattachary et al., 2010). In humans, the uterus becomes receptive during the midsecretory phase of the menstrual cycle (days 19-23), commonly known as the window of implantation (WOI). It is assumed that inadequate uterine receptivity is responsible for approximately two-thirds of implantation failures (Simon et al., 1998). Since an impairment of endometrial receptivity may be a cause of subfertility in a group of couples diagnosed with unexplained infertility (Jasper et al., 2006; Boroujerdnia \& Nikbakht, 2008; Konac et al., 2009). Endometrial scratching may help a group of couples with unexplained infertility.

Conditions

Interventions

TypeNameDescription
PROCEDUREEndometrial scratchingGroup A: pipelle Group B: sound

Timeline

Start date
2013-12-01
Primary completion
2014-06-01
Completion
2014-06-01
First posted
2014-03-12
Last updated
2014-03-12

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT02084914. Inclusion in this directory is not an endorsement.