Is endometrial withdrawal bleeding necessary prior to ovulation induction with clomiphene citrate?;A randomized controlled trial and feasibility study

Completed

• Conditions: PCOS/non-PCOS; WHO 2 ovulation disorders; 10013356

• Registration Number: NL-OMON43480
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

WHO classification category 2 PCOS or non-PCOS
Age between 18 - 41 years
Patent Fallopian tubes, proven by hysterosalpingography (HSG), a negative Chlamydia antibody titre (CAT) or diagnostic laparoscopy combined with tubal testing (DLS and TT), depending on the local protocol.
BMI < 40 kg/m2

Exclusion Criteria

BMI > 40 kg/m2
Previous unsuccessful ovulation induction cycles with clomiphene citrate
Double-sided tubal pathology
Moderate - severe male infertility (TMSC < 3 million)
Grade III/IV endometriosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints are the time to pregnancy and ongoing pregnancy rate<br /><br>within a treatment horizon of 3 cycles. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include time to ovulation, endometrial thickness, multiple<br /><br>pregnancy and the incidence of treatment failure.</p><br>