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

January 2, 2015 updated by: Yilei He, Peking University Third Hospital

The Influence Factors of Ovarian Response in Polycystic Ovary Syndrome Patients(PCOS) With In Vitro Fertilization and Embryo Transfer (IVF-ET) Treatment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oocyte number
Time Frame: 3 Month
Affect the outcome of IVF-ET treatment
3 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate
Time Frame: 3 Month
The success rate of IVF-ET treatment elevated
3 Month
OHSS complication
Time Frame: 3 Month
The number of OHSS patients reduced
3 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

Beijing University Health Science Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

December 31, 2014

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 2, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014180

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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