Infertility / Subfertility
Conditions
Interventions
Endometrial scratch during the luteal phase: 6/7 days after the LH-surge. If
patients do not want to undergo the scratch during the luteal phase, patients
can indicate this and have the procedure sc
in case of a
mean cycle duration of 25 days or shorter, the scratch is planned on cycle day
X (cycle duration minus 15 days) at the latest.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative live birth rate (of which the *ongoing* status should be achieved within 12 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Live birth rate with ongoing pregnancy within 12 months after randomisation - Live birth rate 3 months after randomization - Ongoing pregnancy rate - Clinical pregnancy rate - Biochemical pregnancy rate - Biochemical pregnancy loss rate - Miscarriage rate - Multiple pregnancy rate - Time to pregnancy - Progression to IUI treatment - Progression to IVF treatment - Costs - Endometrial tissue (including endometrial gene expression analysis, endometrial microbiome analysis) - Endometrial organoids - Pregnancy complications - Complications of endometrial scratching - Vaginal swabs (vaginal microbiome analysis) (only in UMC Utrecht in women who are randomized for scratch) | — |
Countries
Netherlands
Outcome results
None listed