Infertility, Unexplained Infertility
Conditions
Keywords
intra-uterine insemination, endometrial injury, scratching
Brief summary
This study will evaluate the potential benefits of uterine injury during the follicular phase of an intra-uterine insemination cycle on the rate of ongoing pregnancy during the first trimester ultrasound.
Detailed description
Infertility is defined as the absence of conception after a year of unprotected intercourse. In 10 to 30 % of patients, the cause of the infertility is unknown. An emerging practice in unexplained infertility has been to cause a uterine trauma prior to treatment. This is done by doing a small endometrial scratch with a pipelle. This intervention has been study in IVF and has been shown beneficial. Theoretically, the uterine scratching could increase the immune response and the vascularization of the endometrium which could help in embryo implantation. However, there is very few data concerning scratching in intrauterine insemination. The studies are mostly small studies and the results are often contradictory. In this randomized controlled trial, the investigators will evaluate the effect of uterine scratching during the follicular phase of an insemination cycle on the pregnancy rate of a large cohort of unexplained infertile couples.
Interventions
PROCEDUREEndometrial scratching
Endometrial Biopsy by aspiration with a pipelle
Sponsors
Clinique Ovo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 41 Years
Healthy volunteers
Yes
Inclusion criteria
* Unexplained infertility for over 12 months if under 35 years old or over 6 months if 35 years old and above. * At least one permeable tube on hysterosonography or hysterosalpingography within the last 2 years or vaginal delivery in the last 3 years. * Antral follicular count over 5. * Normal or mild male factor. * Normal uterine cavity. * An IUI prescription.
Exclusion criteria
* Polycystic ovary syndrome with irregular menstrual cycles over 45 days * Severe endometriosis * IUI with Donor sperm * Patient with invasive intra-uterine procedure in the last 3 months. * Contraindication to endometrial biopsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Pregnancy Rate measured during the first trimester ultrasound. | 13 weeks | Ongoing pregnancy during the first trimester ultrasound after an intrauterine insemination (IUI) cycle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Secondary pregnancy rate. | 6 months | Ongoing pregnancy during the first trimester ultrasound in the 3 IUI cycles following a scratching |
| Safety - Side effects | 6 months for all 3 intrauterine insemination | Evaluate side effects related to the intrauterine scratching |
| Safety - Complications | 6 months for all 3 intrauterine insemination | Evaluate complications related to intrauterine scratching |
Countries
Canada
Outcome results
None listed