To asses whether endometrial scratching increases live birth rates in couples with unexplained infertility and a good prognosis (Hunault>30%)?
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cumulative live birth rate (of which the *ongoing* status should be achieved
within 12 months).
Secondary outcome
- 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)
Background summary
In up to 50% of subfertile couples infertility is diagnosed as being
*unexplained*. Some of these couples may have an endometrial factor that
negatively impacts implantation. It has been suggested that the chances of
implantation after IVF are increased by intentionally injuring (*scratching*)
the superficial lining of the womb. The inflammatory response will enable the
endometrium to acquire a state of optimal receptivity thereby positively
affecting live birth rates. Women with unexplained infertility in a strategy of
expectant management may also benefit from this scratching procedure.
Study objective
To asses whether endometrial scratching increases live birth rates in couples
with unexplained infertility and a good prognosis (Hunault>30%)?
Study design
Randomized controlled non-blinded multi-center superiority trial with 12 months
of follow-up. We will include 396 women in each arm (total 792) to identify a
meaningful difference between the comparison groups
Intervention
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 scheduled during the follicular phase.
The scratch will then be scheduled between cycle day 5 and 11; 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.
Study burden and risks
Patients who are randomized for endometrial scratching will pay one extra visit
to the hospital. From existing literature it is clear that the rate and extent
of adverse events is very low. The benefit is a potential increase in the
chance to conceive.
Heidelberglaan 100
CX 3584
NL
Heidelberglaan 100
CX 3584
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL62675.041.17 |
| Other | NTR Kandidaattrial 27811 |
| OMON | NL-OMON22066 |