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Endometrial Injury in Women With Unexplained Infertility

Endometrial Injury Does Not Improve Pregnancy Rates in Women With Unexplained Infertility

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02628756
Enrollment
120
Registered
2015-12-11
Start date
2013-06-30
Completion date
2015-07-31
Last updated
2015-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unexplained Infertility

Brief summary

Women between 18-39 years old who had been infertile (primary or secondary) for at least 1 year were recruited. In a parallel assignment eligible participants were randomized to receive either a single, site-specific endometrial injury guided by hysteroscopy (Study group) or no intervention (Control group). Natural cycle folliculometry + timed sexual intercourse were offered for all participants for the ongoing and the immediate 2 concecutive cycles. Clinical pregnancy rates were the primary outcome and miscarriage rates were the secondary outcome measures.

Detailed description

A single site-specific hysteroscopic injury procedure (Snip) will be performed using an office hysteroscopy (Karl Storz, Germany). By means of vaginoscopy, a 2.9 mm. continuous-flow diagnostic hysteroscope with a 5 Fr. working-channel is guided through the cervical canal with normal saline as distension medium, with flow manually regulated through the key of the hysteroscopic sheath. The examination of the uterine cavity begins by observing its regularity, paying special attention to the presence of intrauterine malformations or morphologic alterations such as submucous myomas, or uterine septa. Subsequently, A claw forceps will be introduced through a 2.2 mm working channel, and will be used to generate a local injury on the upper posterior endometrium (Endometrial Snip) at midline 10-15 mm from the fundus on D4 to D7 of the ongoing menstrual cycle. The depth and width of the injured site will be about 2x2 mm (i.e a single bite of the claw forceps). No premedications, antibiotics or hemostatics will be given after the procedure. Natural cycle folliculometry + timed sexual intercourse will be offered for all participants for the ongoing and the immediate subsequent cycles. Once the leading ovarian follicle will reach a size of at least 16 mm, 10,000 IU of hCG will be administered to trigger ovulation.

Interventions

Office hysteroscopy (Karl Storz, Tuttlingen, Germany)

Sponsors

Mansoura Integrated Fertility Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age between 18 and 39 years old. 2. Normal HSG and/or diagnostic laparoscopy. 3. Normal seminal profile. 4. Regular ovulation confirmed by mid-luteal progesterone. 5. Normal TVS criteria.

Exclusion criteria

1. Uterine fibroid. 2. Pelvic endometriosis. 3. Irregular menstruation. 4. Ovarian cysts.

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rates (PR)Three consecutive months

Secondary

MeasureTime frame
Miscarriage ratesThree consecutive months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026