Current Clinical Studies

PPCOS II

Pregnancy in polycystic ovary syndrome II

A 20-week double-blinded randomized trial of clomiphene citrate and letrozole for the treatment of infertility in women with polycystic ovary syndrome
Status: Open Enrollment (in Denver and Colorado Springs)
Summary: To determine the safety and efficacy of ovulation stimulation medications, clomiphene citrate, a selective estrogen receptor modulator (current treatment), compared to letrozole, an aromatase inhibitor (investigational treatment), in achieving live birth in infertile women (18-40) with polycystic ovary syndrome (PCOS).

Coordinator: Mallary Crow
Primary Investigator: Dr. Ruben Alvero

Pregnancy Registry

Registry of Pregnancies Conceived following Exposure to Ovulation Stimulation Medications

Status: Approved and enrolling patients who become pregnant in one of the RMN pregnancy studies.
Summary: Part of RMN, a registry of all women who become pregnant under one of the RMN current projects (PCOS, AMIGOS). Follows pregnancy through birth outcome and infant development up to age 3. Registry aims to identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3.

Coordinator: Mallary Crow
Primary Investigator: Dr. Ruben Alvero

Oncofertility

Ovarian Tissue Freezing For Fertility Preservation in Females Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen: A Study by the National Physicians Cooperative of the Oncofertility Consortium

Status: Open Enrollment. Eligible patients should be referred for fertility preservation consultation from the REI physicians.

Summary: Study will aim to collect and cryopreserve ovarian tissue from reproductive age women about to undergo chemo or radiation treatment for cancer:

1. to attempt to preserve fertility options for reproductive age women who are soon to be undergoing chemo or radiation therapy that is likely to cause ovarian destruction and subsequent sterility and
2. to obtain tissue for basic science research into in vitro maturation, ovarian or follicular cryopreservation, or other basic work that would improve our ability to provide fertilizable oocytes to women undergoing cancer treatment or other treatments that may sterilize the ovaries.

Coordinator: Dina Itani
Primary Investigator: Dr. Laxmi Kondapalli

AMGIOS

Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation

Status: Open Enrollment.

Summary: To identify a pharmacologic agent which helps couples in whom the female partner (age 18-40) ovulates regularly successfully obtain their goal of delivering a healthy child, whose use will result in low rates of multiple gestations. Specifically comparing in ovulatory women undergoing ovarian stimulation (OS) and intrauterine insemination (IUI), the use of aromatase inhibitors (AI) will stimulate the ovaries sufficiently to produce no reduction in the rate of pregnancy, while significantly reducing the numbers of multiple gestational pregnancies that result from stimulation with CC or FSH.

Coordinator: Amy King
Primary Investigator: Dr. Ruben Alvero