Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT01325805
Eligibility Criteria:
Inclusion Criteria:
1. Unexplained recurrent pregnancy loss (2 or more prior miscarriages)
2. BMI \>=25 kg/m2
3. Prepared to take 3 months ¡®time out¡± from attempting to conceive
4. Ability to attend a one hour initial, then 30 minute follow-up nutrition/monitoring session - once per week for one month, then every other week for 2 months, then once then once per month for 3 months.
Exclusion Criteria:
1. Age \>=40 years
2. Diagnosis of Type 1 or Type 2 Diabetes as defined by a fasting glucose \>=126, or 2 hour glucose \>=200 by a 75 gram oral glucose challenge
3. Presence of an endocrine condition such as hyperprolactinemia, Cushing¡-s syndrome or untreated thyroid disease (defined as a TSH outside of the laboratory determined normal range)
4. Desire to continue attempts to conceive for the duration of the program
5. History of bariatric surgery
6. Use of over-the-counter or prescribed weight loss medications with the exception of metformin
7. Enrollment in another clinical trial (excluding surveys)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT01325805
Study Brief:
Protocol Section:
NCT01325805