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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Subfertility, Infertility

Intervention / Treatment
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* Procedure: Office-hysteroscopy with biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard treatment | |
| Experimental: Intervention<br>Office-hysteroscopy with endometrial biopsy before standard treatment | Procedure: Office-hysteroscopy with biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF treatment, Office-hysteroscopy, Endometrial biopsy