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

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02331758
• Collaborator: Beijing University Health Science Center (Other)
• Enrollment: 1,000
• Arms: 2
• Duration (Months): 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Behavioral: Lifestyle Counseling	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Influence Factors of Ovarian Response in Polycystic Ovary Syndrome Patients(PCOS) With In Vitro Fertilization and Embryo Transfer (IVF-ET) Treatment
• Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Sep 1, 2015
• Anticipated Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Lifestyle Counseling; The investigators do lifestyle counseling for PCOS patients and monitor the factors to normal level, like BMI, serum index etc.
No Intervention: No treatment Patients without any intervention and still have abnormal factors like BMI, etc.

Outcome Measures

Primary Outcome Measures

1. oocyte number [3 Month]

   Affect the outcome of IVF-ET treatment

Secondary Outcome Measures

1. Success Rate [3 Month]

   The success rate of IVF-ET treatment elevated

2. OHSS complication [3 Month]

   The number of OHSS patients reduced

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Exclusion Criteria:

• Unwilling to participate

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Peking University Third Hospital
• Beijing University Health Science Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yilei He, Yilei He, Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT02331758
• Other Study ID Numbers: 2014180
• First Posted: Jan 6, 2015
• Last Update Posted: Jan 6, 2015
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome

Study Results

No Results Posted as of Jan 6, 2015