University of Rochester, Strong Fertility Center
Rochester, New York, 14623, United States
NCT Number: NCT01788215
The purpose of this study is to study the effect of a commonly used antibiotic, doxycycline, on the production of ovarian hormones and menstrual cycles in women with Polycystic Ovarian Syndrome (PCOS).
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Notify Me18 year–40 year
Female
Interventional
Phase 3
Rochester, New York, 14623, United States
Polycystic ovarian syndrome (PCOS) is one of the leading causes of female infertility, affecting 5-10% of reproductive-age women . This heterogeneous disorder is characterized by anovulatory infertility, androgen excess, an increase in the ratio of LH to FSH, and morphologic polycystic changes to the ovaries. Obesity and insulin resistance are also metabolic factors associated with PCOS that further increase the morbidity in these patients. Inducing fertility in patients with PCOS can be a challenge, as it most often involves ovulation induction that can lead to ovarian enlargement, hyperstimulation, and multiple-birth pregnancies. This study is designed to determine novel effective strategies to promote normal cycling in this patient population.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
200mg/day in divided doses of 100mg twice daily
1 pill twice a day
Other names: Placebo
Time frame: 24 weeks
We will determine total serum testosterone levels in all participating subjects at week 24.
Time frame: week 12
We will determine total serum testosterone levels in all participating subjects at week 12.
Time frame: 24 weeks
Serum progesterone levels will be obtained on a weekly basis to assess ovulation. We will then perform statistical analysis on this data to determine the effectiveness of doxycycline in this study population.
Time frame: week 12
Time frame: week 24
Time frame: week 12
Time frame: week 24
Time frame: week 24
The total number of ovulations per group. Ovulation was defined as elevation of serum progesterone and or urinary pregnanediol glucuronide followed by documented menstrual bleeding within 2 weeks of elevation.
University of Rochester
Other
The Use of an MMP Inhibitor, Doxycycline, to Reduce Ovarian Androgen Production and Restore Normal Cycling in Women With Polycystic Ovarian Syndrome
Acronym: MI-PCOS
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