Comparative, controlled trial of treatment of minor uterine cavity abnormalities diagnosed by office hysteroscopy screening in women indicated for IVF.

Completed

Conditions: uterine cavity abnormalities
10013364

Registration Number: NL-OMON30448

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

- Normal Transvaginal Ultrasound
- No prior hysteroscopy
- Age <= 36 years
- Regular menstrual cycle
- Single Embryo Transfer
- BMI between 18 and 29
- Presence of both ovaries
- Primary or secondary infertility
- Women indicated for a first IVF/ICSI treatment

Exclusion Criteria

- Recurrent miscarriage
- Prior hysteroscopic treatments
- Endometriosis >= AFS Stage III
- Meno-metrorrhagia (defined as any intermenstrual loss of blood)
- Submucosal/Intracavitary Fibroids taking more than 50% of the cavity
- Hydrosalpinx
- FSH/ LH > 12 IU/L on day 3
- Polyps taking more than 50 % of the cavity

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are:<br /><br><br /><br>Uterine cavity condition<br /><br>1. Normal cavity (including uterus arcuatus), or<br /><br>2. Predefined Cavitary Abnormality:<br /><br>- Partial septum (<50% of the cavity)<br /><br>- Submucosal Fibroid: grade 0 (see classification)<br /><br>- Endometrial Polyps taking less than 50% of the cavity<br /><br>- Moderate adhesions: <grade III (grade I to III, see classification)<br /><br>- Chronic or acute endometritis (Diagnosed by the pathologist)<br /><br><br /><br>The main study endpoints are:<br /><br>• Cumulative Ongoing pregnancy rate achieved in a one year IVF/ICSI treatment<br /><br>period<br /><br>• Cumulative implantation rate achieved within a one year IVF/ICSI treatment<br /><br>period</p><br>

Secondary Outcome Measures