The Influence Factors of Ovarian Response in PCOS Patients With IVF-ET Treatment

Not Applicable

• Conditions: Polycystic Ovary Syndrome
• Interventions: Behavioral: Lifestyle Counseling

• Registration Number: NCT02331758
• Lead Sponsor: Peking University Third Hospital

Brief Summary

The purpose of this study is to explore the factors which affect ovarian response of PCOS patients with IVF-ET treatment, in order to provide predictive clinical index for the outcome of IVF-ET treatment in PCOS patients. After figuring out the controllable factors, researchers would be able to educate PCOS patients and improve the success rate while reducing the incidence of complications during the treatment at the same time.

Detailed Description

Statistics of PCOS patients like age, BMI index and others would be collected. Through distributing questionnaires and query of past cases and collecting data recorded during the ovulation process like monitoring fluctuations in blood and ultrasonic monitoring results, researchers obtain the risk factors of the occurence of Ovarian Hyperstimulation Syndrome(OHSS) in IVF-ET treatment in PCOS patients and set up an OHSS prediction model, choose controllable factors in order to make up guidance and have intervention on patients with PCOS accordingly. The investigators expect this could improve the success rate of IVF-ET treatment in patients with PCOS, provide clues and assist to reduce the risk of the therapy.

Study Timeline

• Status Verified: 2014-12
• Study First Submitted: 2014-12-31
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-02
• Last Update Submitted: 2015-01-02
• Study First Posted: 2015-01-06
• Last Update Posted: 2015-01-06
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• Clinical diagnosis of PCOS
• Long schedule time of Luteal phase
• Available to trace
• Normal Prolactin level with contraceptive treatment in recent 3 months

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Exclusion Criteria

• Unwilling to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Lifestyle Counseling	The investigators use several methods to educate patients of controllable factors like lifestyle counseling, and monitor the factors like BMI and other index until the statistics become normal.

Primary Outcome Measures

Name	Time	Method
oocyte number	3 Month	Affect the outcome of IVF-ET treatment

Secondary Outcome Measures

Name	Time	Method
Success Rate	3 Month	The success rate of IVF-ET treatment elevated
OHSS complication	3 Month	The number of OHSS patients reduced