Hysteroscopy Before in Vitro Fertilization - Does it Improve the Outcome?

Hvidovre University Hospital

Status: Completed

Conditions: Infertility; Subfertility

Treatments: Procedure: Office-hysteroscopy with biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01743391

H-4-2012-158

Details and patient eligibility

About

By randomizing sub-fertile women to either control or office-hysteroscopy in the circle prior to IVF or ICSI (intracytoplasmatic sperm injection

) treatment, we aim to enlighten whether hysteroscopy with endometrial biopsy increases pregnancy rates in the intervention group.

Full description

Background A tenth of a population in Denmark today is the result of assisted fertility, including IVF and ICSI. In roughly 40 % of these subfertile women the reason is unknown. Standard initial procedures include transvaginal ultrasonography, with or without saline infusion to detect intrauterine abnormalities that might explain the infertile condition. The golden standard to detect intrauterine abnormalities is hysteroscopy. Such abnormalities can be detected in a fourth of this population. Earlier studies indicate that the hysteroscopy alone - without correcting any abnormalities, affects IVF/ISCI outcome positively.

Aim By randomizing patients referred to the fertility clinic to ±office-hysteroscopy in circle prior to IVF/ISCI, we aim to enlighten whether mini-hysteroscopy with endometrial biopsy will increase the fertility by looking at pregnancy rates as our main outcome.

Method Women signed up for second IVF/ISCI treatment will be recruited, after signed consent they are randomized to either office-hysteroscopy or nothing before standard treatment in the fertility clinic.

Mini-hysteroscopy is a standard procedure in our gynecological outpatient clinic. The procedure is done without any anesthetics. Only women with normal intrauterine conditions will be enrolled in this protocol.

When the fertility clinic has a positive serum-HCG (human chorionic gonadotropin

) and a positive transvaginal sonography, pregnancy is confirmed. If negative serum-HCG, negative pregnancy will be registered.

Enrollment: 220 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women submitted to IVF or ISCI treatment
• Age > 18 years
• Women able to read, speak and understand Danish
• Written consent

Exclusion criteria

• Intrauterine abnormalities
• Infection
• BMI > 35
• Known intrauterine cause to the infertile condition
• Abuse of alcohol or drugs
• Untreated medical condition
• Pregnancy

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Control

No Intervention group

Description:

Standard treatment

Intervention

Experimental group

Description:

Office-hysteroscopy with endometrial biopsy before standard treatment

Treatment:

Procedure: Office-hysteroscopy with biopsy