|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
28 April 2015 |
|
Main ID: |
NCT02416960 |
|
Date of registration:
|
07/04/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of the Glycemic Index of Diet on Metabolic and Reproductive Parameters in Overweight and Obese Infertile Women
|
|
Scientific title:
|
Effect of a Hypocaloric Diet With Different Glycemic Indexes on Ghrelin and Leptin Levels, Metabolic Parameters, and Reproductive Outcomes in Overweight and Obese Infertile Women: A Randomized Clinical Trial |
|
Date of first enrolment:
|
January 2012 |
|
Target sample size:
|
45 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT02416960 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Brazil
| | | | | | | |
|
Contacts
|
|
Name:
|
Cileide C Moulin, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
UFRGS/HCPA |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Diagnose of female infertility and indication for treatment with in vitro
fertilization
- Body Mass Index (BMI) equal or greater than 30 kg/m² or BMI > 25 kg/m² with increased
waist circumference (> 80 cm);
- Being not treated (diet) for weight loss/gain and maintaining stable body weight in
the three months prior to the study;
- Not having stomach/digestive problems
- Not having the knowledge of cardiovascular disease history;
- Non-smokers;
- Not using any medication.
Exclusion Criteria:
- Patients with BMI equal or higher than 40 kg/m² (morbid obesity)
- Patients who are already receiving some type of nutritional intervention
- Patients with co-morbidities that may interfere with reproductive capacity (genetic
and/or endocrine disorders, diabetes mellitus, cancer, liver or kidney failure),
alcoholics, individuals who have contact (work) with heavy metals or chemicals
(exposure to solvents and pesticides)
- Lack of adherence to the proposed dietary treatment
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Female Infertility
|
|
Obesity
|
|
Intervention(s)
|
|
Other: Conventional Diet Group
|
|
Other: Low Glycemic Index Diet Group
|
|
Primary Outcome(s)
|
|
Clinical Pregnancy Rate
[Time Frame: up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle]
|
|
Secondary Outcome(s)
|
|
Number of Oocytes Retrieved
[Time Frame: between 12 and 16 weeks, during the in vitro fertilization cycle]
|
|
Embryo Quality
[Time Frame: between 12 and 16 weeks, during the in vitro fertilization cycle]
|
|
Leptin Levels (ng/mL)
[Time Frame: baseline and 12 weeks]
|
|
Body Fat Percentage (%)
[Time Frame: baseline and 12 weeks]
|
|
Percentage of Fertilized Oocytes (%)
[Time Frame: between 12 and 16 weeks, during the in vitro fertilization cycle]
|
|
Acylated Ghrelin Levels (pg/dL)
[Time Frame: baseline and 12 weeks]
|
|
HOMA-IR index (Homeostasis Model Assessment)
[Time Frame: baseline and 12 weeks]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|