Obese Clinical Trial
Official title:
The Effects of an Intensive Lifestyle Intervention on Reproductive Outcomes in Obese, Subfertile Women
Verified date | December 2015 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 14 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UMichigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
Amy E Rothberg | University of Michigan |
United States,
Clark AM, Thornley B, Tomlinson L, Galletley C, Norman RJ. Weight loss in obese infertile women results in improvement in reproductive outcome for all forms of fertility treatment. Hum Reprod. 1998 Jun;13(6):1502-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of Life | Improvement in quality-of-life as measured by the EuroQol-5D and the short-form Impact of Weight on Quality of Life (IWQOL-Lite), and psychological well-being as measured by the (Inventory of Depressive Symptomatology-Self Reported) IDS-SR. | 24 months | No |
Other | Maternal Health | Evaluate maternal health during pregnancy by review of medical records including ultrasound findings, laboratory investigation, any complications of pregnancy, number of weeks of gestation at time of delivery, mode of delivery and post delivery complications | 24 months | No |
Other | Fetal Health | Evaluate the record for weight, height, head circumference, Apgar scores, complications of delivery, type of delivery, and overall health and development of baby at delivery and for one year after birth. | 36 months | No |
Primary | Improvement in ovulatory cycling | The rate of spontaneous cycling (detected by LH surge) or evidence of menses. Improvement in either unassisted and clomiphene-assisted ovulation (for up to and including 3 cycles of clomiphene citrate) | 24 months | Yes |
Secondary | Metabolic State | Improvement in weight, BMI, waist circumference, hip circumference Improvement in co-morbid health conditions as measured by HbA1C, fasting plasma glucose, total cholesterol profile, HDL, non-HDL and LDL cholesterol levels, glucose and insulin levels (measured during 2 hour oral glucose tolerance testing), leptin, estradiol, LH, FSH, total testosterone levels Changes in molecular phenotype in response to change in dietary nutrients as measured by metabolomic profiling | 24 months | No |
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