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

NCT ID: NCT02331758

Last Updated: 2015-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lifestyle Counseling

Intervention Type BEHAVIORAL

The investigators do lifestyle counseling for PCOS patients and monitor the factors to normal level, like BMI, serum index etc.

No treatment

Patients without any intervention and still have abnormal factors like BMI, etc.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle Counseling

The investigators do lifestyle counseling for PCOS patients and monitor the factors to normal level, like BMI, serum index etc.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beijing University Health Science Center

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yilei He

Yilei He

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2014180

Identifier Type: -

Identifier Source: org_study_id

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