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Uterine Scratching in Intra-Uterine Insemination

O

Ovo Clinic

Status

Completed

Conditions

Infertility
Unexplained Infertility

Treatments

Procedure: Endometrial scratching

Study type

Interventional

Funder types

Industry

Identifiers

NCT03828786
ovo-18-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

394 patients

Sex

Female

Ages

18 to 41 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

394 participants in 2 patient groups

Endometrial scratching group
Active Comparator group
Description:
Endometrial scratching will be done with a Pipelle in uterus.
Treatment:
Procedure: Endometrial scratching
Control group
No Intervention group
Description:
This group will proceed with intrauterine insemination without endometrial scratching according to clinic's standard procedure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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