A weight-loss programme and subsequent fertility rates in an assisted reproductive technology programme

Phase 3

Completed

• Conditions: Obesity; Diet and Nutrition - Obesity; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12606000448549
• Lead Sponsor: Royal Prince Alfred Hospital - Fertility Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-18
• Study Completion: 2010-05-31
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 47

Inclusion Criteria

A patient enrolled to undergo IVF at the Royal Prince Alfred Hospital Fertility Unit, and be clinically obese, defined as a BMI greater or equal to 30.0 kg/m2

Exclusion Criteria

(1) individuals with current psychiatric conditions (i.e. psychosis, severe depression, and drug or alcohol abuse); (2) significant physical conditions (i.e. malignancy, significant hepatic or renal dysfunction or musculoskeletal disease that would preclude full participation in the study); (3) presence of an endocrine condition (other than polycystic ovarian syndrome), such as hyperprolactinaemia (> 450 IU/L), untreated thyroid disease and Cushing’s syndrome; (4) current or recent treatment (within 3 months) known to affect diet or body weight; and/or (5) patients unwilling to suspend IVF treatment for up to 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy rate (diagnosed as fetal heartbeat at 7 weeks gestation) per woman[At 12 months after the cessation of the 12 week program]