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Research and Clinical Trials

The Reproductive Research Unit (RRU) at Penn Fertility Care
The Reproductive Research Unit (RRU) is the dedicated research facility at Penn Fertility Care. The RRU was founded in 1996 and continues The University of Pennsylvania's long tradition of excellence in patient care and clinical research.

Current Studies Available
Current studies include methods of family planning, treatment for heavy bleeding, treatment for decreased sexual desire, development of microbicides, and more. If you would like to find out more information about or participate in any of the following studies, please call 1-800-789-PENN.

Genetics of PCOS

Penn is are currently recruiting women with polycystic ovary syndrome (PCOS) and their parents in a study to understand the genetics of PCOS. Subjects will be asked to provide a sample of sputum (mucus from the respiratory tract) which will be used to obtain DNA. No visits are required as subjects will be mailed the DNA saliva kits.

For more information please contact Linda Martino at 215-615-3664.

Weight Loss Study for Women

Eligible women between the ages of 18 and 40 who are overweight and are experiencing irregular menstrual cycles, infertility or polycystic ovarian syndrome (PCOS) can participate in a weight loss program that will examine the effects of weight loss on reproductive function. Participants will receive health assessments before and during the program that include body composition testing, blood tests and a comprehensive assessment for PCOS. Participants will be compensated for their time and the weight loss treatment is free.

For more information about the study and to find out if you qualify, call the Center for Weight and Eating Disorders at 215-898-7314.

Escitalopram For Premenstrual Syndrome (Pms) In Teenagers

This research study examines the efficacy of escitalopram for PMS in teens, ages 15-19 years.  Escitalopram is a serotonergic medication that is sold by prescription.  Similar drugs have demonstrated efficacy for PMS in adult women.  Eligible teens will receive escitalopram or a placebo (sugar pill).  Study participation is approximately 6 months. 

Call the Penn PMS Program at 215-662-3329 or 1-800-662-4487.

Birth Control Pill Study

This industry-sponsored study is comparing a new investigational contraceptive pill with another contraceptive pill, which is already available on the market. For the first time, this new pill uses natural estrogen (just like the body's own hormone) in the place of the synthetic alternative (ethinyl estradiol) that's used in existing combined oral contraceptives. The progestogen hormone being used in the pill is also new in its use for contraception.

This study will also evaluate the effects of this new birth control pill at preventing pregnancy and controlling your menstrual cycle. This study aims to confirm the efficacy and safety of the new pill. The study will also examine other effects of this new combination of hormones, such as how they affect mood, sexuality and symptoms related to the menstrual period.

Participants should be healthy heterosexually active females, between the ages of 18-50 years, at risk for pregnancy and willing to use an oral contraceptive pill for 1 year.

All women taking part in the study will receive confidential medical examinations, blood tests and supply of the pill at no cost. All inquiries will be treated in the strictest confidence.

Ovarian Reserve in Female Pediatric Cancer Survivors

Female cancer survivors who received chemotherapeutic agents such as cytoxan and or ifosfamide may have problems with their ovarian function. This privately funded study seeks to determine if certain types of tests (blood tests and ultrasound) can detect decreases in the number and quality of eggs (ovarian reserve) in female survivors before the possible onset of complete ovarian failure.

Survivors between the ages of 15 and 30 who were diagnosed at least five years ago and have not had any cancer therapy in the past two years may take part in this study. Study participants must also have received an alkylating agent in chemotherapy and must have had their first period.

Decreased Sexual Desire in Women

If you are a pre-menopausal woman (still experiencing regular menstrual cycles) with a decrease in your sexual desire, you are invited to see if you may qualify for a medical research study for women concerned about their decreased sexual desire. This industry sponsored study examines the effectiveness and safety of an investigational medication for HSDD (Hypoactive Sexual Desire Disorder), the most common form of female sexual dysfunction.

HSDD is typically identified by decreased or absent sexual fantasies and desire for sex – and the exact cause is unknown. Qualified participants will receive investigational study medication, study-related medical exams, and lab tests at no charge. Financial compensation for time and travel may also be available.

Contraceptive Vaginal Ring Study

This study is for women between the ages of 18 and 40 who are willing to use a vaginal birth control ring for 13 cycles, which is about one year. Participants must wish to use combined hormonal birth control (the ring delivers150 micrograms of Nesterone (a progestin) and 15 micrograms of ethiyl estradiol per day), and not intend to become pregnant for the next 13 months.

For each cycle women will insert the ring in the vagina and it will remain there for three weeks. After that three week period, the ring will be removed for one week during which time menstruation will occur. This 4 week cycle will be repeated using the same ring for all 13 cycles of participation.

Participating women, who are willing to stop using their current birth control method, will be asked to provide medical history, complete medical exams and keep diaries of how they use the ring. Also, the participant must be willing to record dates of any vaginal bleeding, information on whether the ring falls out, and condom usage or use of any vaginal products during the study. There are 7 office visits during the course of the study with an additional 5 follow up phone calls.

N-9/HEC Study

This 3 to 6 month study seeks to investigate the inflammatory effects of Nonoxynol-9 (Gynol II) and Hydroxyethyl Cellulose (HEC) gel (a universal placebo) on the upper and lower reproductive tract of women between the ages of 18 and 45. Since this is a cross-over study women who are randomly assigned to one treatment, which they use for 3 days following their menses, may continue their participation in the study by using the other treatment in a subsequent cycle.

Women must agree to use an effective, non-spermicidal method of contraception during the study (oral, transdermal, injectable or implanted), non-lubricated condoms, or male/female sterilization.

Xanodyne Heavy Menstrual Bleeding Study

This 2-year open-label clinical trial seeks to determine the safety and efficacy of an investigational agent called Tranexamic Acid. The drug prevents the breakdown of fibrin, an important factor that makes up a blood clot to stop the flow of blood. All participants are given the medication to take with their periods, three times a day and for no more than five days.

There is no placebo treatment group and this study is recruiting generally healthy women between 18 and 49 years of age with cyclic menorrhagia, (with or without fibroids), who desire a non-hormonal method of treatment. If you are at risk for pregnancy you will need to use a barrier method of birth control for the duration of the study since you cannot take any hormones while in the study.

Contraceptive Effectiveness of C31G Vaginal Gel

This NIH-sponsored study aims to compare an investigational spermicide to a currently marketed product, Conceptrol. The safety and efficacy of this product will be observed in women over the course of six menstrual cycles, with the option of continuing to participate through their twelfth cycle.

Participants should be at least 18 years of age, in general good health, not on hormonal contraception, and willing to use the study gel as their only method of contraception. There is a moderate risk of pregnancy to participants during this trial.

Non-Hormonal Medication for Heavy Menstrual Bleeding

This industry-sponsored study is evaluating an investigational non-hormonal medication for heavy menstrual bleeding. While not approved in the US, this product has been used in other countries for more than three decades to treat hemorrhage and menorrhagia. The safety and efficacy of this product will be studied over 12 menstrual cycles in healthy women, aged 18-49.

In Vitro Fertilization Research

Blood and follicular fluid samples from patients of Penn Fertility Care undergoing in vitro fertilization are being collected and analyzed to investigate ways to predict and enhance IVF success rates, and to try to find reasons for “unexplained” infertility. Factors being studied include blood-clotting factors, amino acids, and markers of egg aging.

For more information about the Reproductive Research Unit and our clinical trials, please contact Penn Fertility Care at 1-800-789-PENN (7366) or 215-662-7727.

 


 

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