Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women - NCT00704912-19104 (Clinical Trial 228906)
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| City: |
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Philadelphia |
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State:
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PA |
| Zip Code: |
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19104 |
| Conditions: |
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Polycystic Ovary Syndrome |
| Purpose: |
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The goal of this three-armed randomized controlled trial is to establish the relative roles
of treatment of hyperandrogenism versus obesity (as the largest modifiable factor
contributing to insulin resistance) in treating infertility and improving pregnancy outcomes
among obese PCOS women. The investigators hypothesize that the key to restoring ovulation
leading to live birth is to correct hyperandrogenism with oral contraceptive pills, but the
key to avoiding later pregnancy complications is to improve insulin sensitivity with weight
loss.
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| Study summary: |
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Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among
women, and women with PCOS are at increased risk for pregnancy complications such as
gestational diabetes and pre-eclampsia. Both hyperandrogenism (HA) and obesity exacerbated
insulin resistance (IR) are characteristics of the syndrome, and are targets for treatment,
but which should be the predominant focus is still unknown. Phase 1 of this study will be a
randomized trial of three preconception interventions in infertile women with PCOS. The
first arm will be a combined intervention of medication, meal replacements, and lifestyle
modification to improve IR. Sibutramine is a combined norepinephrine-serotonin re-uptake
inhibitor that is associated with increased satiation (fullness) and a resulting reduction
in food intake. The second arm will be the use of a continuous OCP for 4 months to improve
HA. Lo-Estrin 1/20 will be used in a continuous method for 4 months to suppress the ovary.
The third arm is the combination of both to improve HA an IR. Phase II of this study will
involve ovulation induction with clomiphene citrate with hopeful outcome of pregnancy.
Finally, Phase III involve following the pregnancies for outcomes and complications. |
| Criteria: |
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Inclusion Criteria:
- Partner with sperm concentration of >=14 million/mL in at least one ejaculate with
motile sperm.
- Ability to have regular intercourse 2-3 times per week during the ovulation induction
phase of study.
- At least on patent tube and normal uterine cavity as determined by sonohysterogram,
hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years.
- No previous sterilization procedures(vasectomy, tubal ligation) tha have been
reversed.
Exclusion Criteria:
- Intermenstrual periods of >= 45 days or a total of <=8 periods per year.
- Elevated total testosterone >50 ng/dL.
- PCO on ultrasound (12 or more follicles measuring 2-9 mm in diameter).
- BMI >=27 to <=40. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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