Status:
COMPLETED
The Effects of an Intensive Lifestyle Intervention on Reproductive Outcomes
Lead Sponsor:
Amy E Rothberg
Collaborating Sponsors:
University of Michigan
Conditions:
Subfertility
Anovulatory
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
This is a study to determine whether a low calorie diet using meal replacement shakes compared to current counseling about diet, followed by 3 cycles of clomiphene citrate (if needed) will result in: ...
Detailed Description
More than 33% of U.S. adults over the age of 20 are obese (BMI ≥30 kg/m2), and 6% are severely obese (BMI ≥40 kg/m2). As the prevalence and severity of obesity has increased, so has the number of wome...
Eligibility Criteria
Inclusion
- Women
- 18 to 35 years old
- Obese(BMI of ≥35≤45 kg/m2)
- Infertility (12 months of unprotected intercourse without conception)
- Ovulatory dysfunction (amenorrhea, irregular cycles, or progesterone level less than 10 ng/mL in the luteal phase)
- Partner with semen analysis demonstrating at least 20 million sperm/mL, 50% motility, and normal morphology by Kruger criteria of 8%
- Evidence of normal uterine anatomy and at least on patent tube documented by hysterosalpingogram or saline infusion sonogram.
- Women with polycystic ovary syndrome
Exclusion
- Significant heart disease (coronary artery disease, Class II-VI Heart Failure, arrythmia)
- Chronic Kidney Disease, Stage IV or greater
- Significant gastrointestinal tract diseases (e.g. IBD)
- Autoimmune disorders (e.g. systemic lupus erythematosus)
- Neurological (e.g. Multiple Sclerosis)
- Psychiatric disorders (Bipolar, Major Depression)
- History of or current eating disorders or substance abuse
- Endocrine disorders (Type 1 diabetes, adrenal, pituitary or uncontrolled thyroid disease)
- HIV/AIDS
- Significant anemia
- History of or current clotting disorder
- Cancer other than minor skin cancers
- Other conditions that would complicated pregnancy.
- Women will be excluded if they are taking anti-obesity drugs, or appetite suppressants within the last 2 months, or have had previous bariatric surgery.
- Women will be excluded if they have used hormonal medications within the last 2 months, previous use of ovulation induction medications, have endometriosis by American Fertility Society (AFS) class III or IV, have an FSH \> 10 IU/mL or couples using donor sperm or are already pregnant.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01894074
Start Date
July 1 2013
End Date
July 1 2015
Last Update
December 4 2015
Active Locations (1)
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1
UMichigan
Ann Arbor, Michigan, United States, 48109