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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743391
• Other study ID #: H-4-2012-158
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: June 2018

Study information

• Verified date: March 2022
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Subfertility

Intervention

Procedure:
• Office-hysteroscopy with biopsy

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital, Department of Gynecology and Obstetrics	Copenhagen	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Holbaek Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy rates	Positive serum HCG and transvaginal ultrasonography, alternatively negative serum HCG and negative outcome will be registrated. After 300 women have been included final outcome will be evaluated.	individual outcome will be evaluated within 8 weeks after IVF treatment. Over all outcome will be evaluated after 3 years.