Does endometrial scratching increase the rate of spontaneous conception in couples with unexplained infertility and a good prognosis (Hunault >30%)?

Recruiting

Conditions: Infertility / Subfertility
10013356

Registration Number: NL-OMON52881

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 792

Inclusion Criteria

1. Diagnosis of Unexplained Infertility (UEI) and a Hunault of > 30%.
2. Female age 18-38 years
3. Primary or secondary infertility lasting at least 1 year
4. Regular menstrual cycle
5. Patent tubes (diagnosed by negative Chlamydia antibody titre and absence of
risk factors for tubal disease, and/or hysterosalpingography or diagnostic
laparoscopy)
6. Total motile sperm count > 3 million
7. Normal transvaginal ultrasound, defined as no visible intracavitary
pathology or intramural myomas with impression of the uterine cavity
8. Written informed consent

Exclusion Criteria

1. History of lower abdominal or pelvic infection
2. Previous surgical procedures of the uterine cervix or cavity
3. Endometriosis grade 3 and 4
4. Previous caesarean section with niche formation
5. The presence of untreated unilateral or bilateral hydrosalpinx
6. Recurrent miscarriage (defined as 2 or more pregnancy losses prior to 20
weeks of gestation)
7. Previous endometrial scratching
8. Meno-metrorrhagia (defined as any intermenstrual loss of blood)
9. Untreated/unsubstituted endocrine abnormalities (e.g. pituitary, thyroid,
adrenal or pancreas

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cumulative live birth rate (of which the ongoing status should be achieved<br /><br>within 12 months).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Live birth rate with ongoing pregnancy within 12 months after randomisation<br /><br>- Live birth rate 3 months after randomization<br /><br>- Ongoing pregnancy rate<br /><br>- Clinical pregnancy rate<br /><br>- Biochemical pregnancy rate<br /><br>- Biochemical pregnancy loss rate<br /><br>- Miscarriage rate<br /><br>- Multiple pregnancy rate<br /><br>- Time to pregnancy<br /><br>- Progression to IUI treatment<br /><br>- Progression to IVF treatment<br /><br>- Costs<br /><br>- Endometrial tissue (including endometrial gene expression analysis,<br /><br>endometrial microbiome analysis)<br /><br>- Endometrial organoids<br /><br>- Pregnancy complications<br /><br>- Complications of endometrial scratching<br /><br>- Vaginal swabs (vaginal microbiome analysis) (only in UMC Utrecht in women who<br /><br>are randomized for scratch)</p><br>