Does Local Injury of the Endometrium Improve Controlled Ovarian Hyperstimulation (COH) + Intrauterine Insemination (IUI) Outcome?

Clalit Health Services

Status: Unknown

Conditions: Infertility; Implantation Failure

Treatments: Procedure: natural cycle + IUI + endometrial biopsy; Procedure: endometrial biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01111799

004608K

Details and patient eligibility

About

It was previously demonstrated in in vitro fertilization (IVF) patients that local injury of the endometrium during a spontaneous menstrual cycle that precedes IVF treatment doubled the rates of implantation and pregnancy. The hypothesis of our present study is that the endometrial injury procedure will have the same beneficial effect in patients undergoing controlled ovarian hyperstimulation (COH) combined with intrauterine insemination (IUI).

Full description

In order to test our hypothesis, we will perform the simple procedure of local injury of the endometrium using a "Pipelle" biopsy catheter during the spontaneous menstrual cycle that precedes a COH + IUI treatment.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18-38.
• infertility.
• patients undergoing IUI treatment.
• at least one failed IUI cycle.

Exclusion criteria

• indication for IVF treatment.
• Known Pelvic inflammatory disease(PID).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 6 patient groups

Clomiphene citrate + IUI + endometrial biopsy

Experimental group

Description:

Clomiphene citrate + IUI + endometrial biopsy

Treatment:

Procedure: endometrial biopsy

Procedure: endometrial biopsy

Clomiphene citrate + IUI

No Intervention group

gonadotrophines + IUI + endometrial biopsy

Experimental group

Description:

two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.

Treatment:

Procedure: endometrial biopsy

Procedure: endometrial biopsy

gonadotrophines + IUI

No Intervention group

natural cycle + IUI + endometrail biopsy

Experimental group

Description:

two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.

Treatment:

Procedure: natural cycle + IUI + endometrial biopsy

natural cycle + IUI

No Intervention group