Clinical
Briefing: Reproductive Research at Penn Fertility Care
September/October 2007
Penn Fertility Care has success rates for ovulation and live births that rank among the highest in the Mid-Atlantic region, and has earned an international reputation for leading edge research.
The treatment of infertility and its complications is constantly evolving, and success rates are increasing yearly. Specialists at Penn Fertility Care are at a particular advantage because their leadership in national and international clinical trials provides access to the most progressive fertility therapies available today.
“Penn Fertility Care offers a full range of services in an environment of compassionate intervention, sophisticated technology, clinical research, and goal oriented reproductive care.
– Christos Coutifaris, MD, PhD
Chief, Division Of Reproductive Endocrinology and Infertility
Director, Penn Fertility Care |
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Clinical Advances in the Treatment of Infertility Associated with Polycystic Ovary Syndrome
A 28-year-old woman with a history of irregular periods (2-4 per year) was referred to Penn Fertility Care by her Ob/Gyn complaining of 2 years of infertility. Evaluation showed the patient to have a BMI of 29, a slight increase in hair growth, and an otherwise normal examination. Laboratory evaluation indicated a minimally elevated total testosterone and pelvic ultrasound documented ovaries with multiple small (<1 cm) cysts. Hysterosalpingogram showed a normally shaped uterus and patent fallopian tubes. Her partner’s semen had been analyzed and was normal. On the basis of these findings, the patient was diagnosed with polycystic ovary syndrome (PCOS).
Traditionally, patients with PCOS would be treated with
a clomiphene citrate ovulation induction regimen. Nonetheless,
because studies in recent years suggest that an insulin sensitizer,
metformin, alone or in combination with clomiphene, increases
the ovulation rate in PCOS patients, practitioners have been
prompted to start all of their patients with PCOS on the
drug — despite a lack of appropriate data on pregnancy
and birth rates.
This patient subsequently enrolled in a clinical trial
at Penn Fertility Care (see next section) with the aim of
evaluating birth rates in PCOS patients treated with clomiphene
citrate alone or in combination with metformin.
Clinical Advances in the Treatment of Infertility – Polycystic Ovary Syndrome
Penn Fertility Care took part in the largest clinical trial to date to evaluate clomiphene citrate, metformin and the combination for their capacity to achieve successful birth in PCOS patients.
Published in the New England Journal of Medicine*, the trial demonstrated that women treated with the ovulation inducing agent clomiphene citrate were 3 times more likely to have live births than women treated with metformin alone.
Most importantly, the addition of metformin did not significantly increase the pregnancy or birth rates achieved with clomiphene alone, thus challenging the current empiric use of this combination of drugs. These findings support the use of clomiphene alone as a first line therapy for ovulation induction in the treatment of infertility associated with PCOS, and reinforce its position as the standard of care in this population.
*Legro RS, Huiman X, Schlaff WD, et al. Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Eng J Med. 2007;356:551-566.
Clinical Trials:
The Reproductive Research Unit at Penn Fertility Care
A national leader in reproductive medicine breakthroughs for over 40 years, Penn Fertility Care also possesses a dedicated Reproductive Research Unit (RRU). The many ongoing clinical trials currently enlisting patients at the RRU include:
- Ovarian Reserve in Pediatric Cancer Survivors – This study seeks to determine whether certain blood tests and ultrasound can detect decreases in the number and quality of eggs (ovarian reserve) in female cancer survivors before the onset of complete ovarian failure.
- In Vitro Fertilization Research – IVF research is currently examining the reasons for unexplained infertility, and investigating ways to predict and enhance IVF success rates.
- Treatment of Women With Menorrhagia – A clinical safety and efficacy trial of tranexamic acid, an investigational drug that prevents breakdown of fibrin, in women with menorrhagia.
- Novel contraceptives – Investigations of a contraceptive vaginal ring and spermicidal C31G vaginal gel are in progress at RRU.
- Decreased Sexual Desire in Women – This trial is researching an investigational medication for decreased sexual desire in premenopausal woman.
- Endometriosis Pain – A 12-week trial investigating management of moderate-to-severe endometriosisrelated pelvic pain in women 18 - 45 years of age. Women must have documented endometriosis by laparoscopy, laparotomy, and/or histology within five years, and moderate or severe nonmenstrual pelvic pain.
To obtain eligibility requirements, or for more information, please call the Reproductive Research Unit at 215-662-7727.
Our Team
Representing generations of excellence in fertility care, Penn Fertility Care offers a comprehensive range of advanced reproductive services at multiple locations in the greater Philadelphia area. Our team of physicians, nurses, counselors, andrologists, and embryologists assist couples coping with the emotional, physical, and technological aspects of achieving pregnancy.
Reproductive Endocrinology and Infertility Specialists
Christos Coutifaris, MD, PhD
Chief, Division of Reproductive Endocrinology and Infertility
Director, Penn Fertility Care
Director, In Vitro Fertilization Program
Professor of Obstetrics and Gynecology
Kurt T. Barnhart, MD, MSCE
Associate Director, Penn Fertility Care
Director, Donor Egg Program
Director, Women's Health Clinical Research Center and the Reproductive Research Unit Associate Professor of Obstetrics and Gynecology
Samantha Butts, MD, MSCE
Assistant Professor of Obstetrics and Gynecology
Clarisa R. Gracia, MD, MSCE
Assistant Professor of Obstetrics and Gynecology
Luigi Mastroianni, Jr., MD
Emeritus Professor of Obstetrics and Gynecology
Samantha M. Pfeifer, MD
Director, Reproductive Surgery Associate Professor of Obstetrics and Gynecology
Steven J. Sondheimer, MD
Director, Family Planning Professor of Obstetrics and Gynecology
Richard W. Tureck, MD
Professor of Obstetrics and Gynecology
Carmen J. Williams, MD, PhD
Assistant Professor of Obstetrics and Gynecology
Kelly Timbers, CRNP
Director of Operations, Center for Women’s Health Clinical Research Center Associate
Director, Reproductive Research Unit
Andrea Boxer, PhD
Clinical Social Worker Penn Medicine at Radnor
Locations
Penn Fertility Care
3701 Market Street, 8th Floor
Philadelphia, PA 19104
Penn Medicine at Radnor
250 King of Prussia Road
Radnor, PA 19087
To refer a patient and/or consult with a doctor call 800-789-PENN(7366) or visit Penn Ferility Care.
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Referring Physicians: To speak with a Penn physician
or refer a patient, contact PennHealth through the secure online
referral form or by calling
1-800-789-PENN
(7366). |
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