NCT02331758

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 6, 2015

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

December 31, 2014

Last Update Submit

January 2, 2015

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • oocyte number

    Affect the outcome of IVF-ET treatment

    3 Month

Secondary Outcomes (2)

  • Success Rate

    3 Month

  • OHSS complication

    3 Month

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

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

No treatment

NO INTERVENTION

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

Interventions

Lifestyle CounselingBEHAVIORAL

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

Lifestyle counseling

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yilei He

Study Record Dates

First Submitted

December 31, 2014

First Posted

January 6, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 6, 2015

Record last verified: 2014-12