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Verhoogt ‘scratching’ van het baarmoederslijmvlies de kans op een spontane zwangerschap in paren met onverklaarde verminderde vruchtbaarheid en een spontane kans op zwangerschap van >30%?

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22066
Enrollment
792
Registered
2017-08-31
Start date
2017-12-31
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Unexplained subfertility, scratching, live birth, implantation, endometrium

Interventions

The scratch will be performed in a natural cycle with LH testing. The scratch will be performed 6 to 7 days after the positive LH test. If, for the individual patient, scheduling on this day is imposs

Sponsors

UMC Utrecht Trial executed within the NVOG-consortium 2.0
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Unexplained Infertility (UEI) and a Hunault of > 30%. 2. Female age 18-43 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/ml 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

Exclusion criteria: 1. History of lower abdominal or pelvic infection 2. Higher chance of intra-abdominal infection due to intestinal surgery (for for instance Crohn’s disease or colitis) 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)

Design outcomes

Primary

MeasureTime frame
Cumulative live birth rate (of which the ‘ongoing’ status should be achieved within 12 months after randomisation)

Secondary

MeasureTime frame
- Ongoing pregnancy rate - Clinical pregnancy rate - Miscarriage rate - Twin birth rate - Time to pregnancy - Progression to IUI treatment - Progression to IVF treatment - Costs - Endometrial tissue parameters in relation to reproductive succes or failure

Contacts

Public ContactHelen Torrance

Heidelberglaan 100

h.torrance@umcutrecht.nl088 7551443

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)