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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02331758
• Other study ID #: 2014180
• Status: Not yet recruiting
• Phase: N/A
• First received: December 31, 2014
• Last updated: January 2, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: December 2014
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Beijing University Health Science Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oocyte number	Affect the outcome of IVF-ET treatment	3 Month	Yes
Secondary	Success Rate	The success rate of IVF-ET treatment elevated	3 Month	Yes
Secondary	OHSS complication	The number of OHSS patients reduced	3 Month	Yes