The Effects of an Intensive Lifestyle Intervention on Reproductive Outcomes

Completed · Not applicable · Has a placebo group

Conditions studied: Subfertility, Anovulatory, Obese

In brief

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: 1) improvements in ability to ovulate and achieve pregnancy either spontaneously or during 3 clomiphene citrate cycles 2) greater weight loss with reductions in waist and hip circumferences and improvements in hormones that are involved in allowing pregnancy to occur and hormones that are involved in metabolism, such as insulin and glucose (sugar) 3) improvements in other health conditions such as blood pressure, and emotional and physical well-being. Women eligible to participate will be between the ages of 18-35 with a BMI (ratio of weight in kg divided by height in m2) of ≥ 35≤45 kg/m2 who are seeking help for anovulatory infertility including women with a diagnosis of polycystic ovarian syndrome (PCOS).

Key facts

Study ID

NCT01894074

Run by

Amy E Rothberg

People needed

14

Starts

2013-07-01

Expected to finish

2015-07-01

Last updated by the study team

2015-12-04

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UMichigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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