Texas Fertility Center

Completed Studies

2018

Protocol: Clinical Study for Minimally Invasive Treatments of Uterine Fibroids
Sponsor: Acessa
Purpose: The Texas Fertility Center is doing a study for women who want a minimally invasive treatment for their symptoms but who do not want a hysterectomy.

2018

Protocol: The TiMMI IVF Incubator Study
Sponsor: Ovation Fertility
Purpose: The MIRI-TL™ is an embryo culture incubator using a built-in microscope and camera designed specifically for the continuous assessment of embryo development. After sperm fertilizes an egg, the IVF laboratory will grow the developing embryo in a Petri dish with a nourishing substance called culture medium. These are stored in carefully monitored and temperature controlled incubators. The goal of this study is to compare the safety and effectiveness of the MIRI-TL compared to industry-standard incubators.

2017

Protocol: NXGeM Culture Media Study
Sponsor: Ovation Fertility
Purpose: This new embryo culture media formulation represents a minor modification of an existing FDA-cleared formulation for in vitro culture and does not appear to cause early degeneration/atresia of human embryos. In the IVF lab, culture medium is the nutrient-rich substance that supports the growth of eggs, sperm and embryos. The goal of this study is to collect embryo development and pregnancy outcome data on embryos that are cultured in “second-generation” culture medium compared to industry-standard culture medium.

2017

Protocol: SeMS Embryo Grading Study
Sponsor: Ovation Fertility
Purpose: Comparing two embryo selection methodologies—standard embryo grading versus individual embryo genetic profiles grading—for determining which genetically screened embryo to transfer in an IVF cycle. The goal of this study is to determine the best method for selecting a genetically normal (euploid) embryo combined with the developmental grade. Empowered with this information, fertility patients and their physicians can choose to transfer a single embryo—the one with the highest probability for developing into a healthy baby.

2015

Protocol: The PROSPECT Study
Sponsor: Auxygen
Purpose: The Early Embryo Viability Assessment Test, is a test to be used by IVF laboratories to analyze early embryo development. At the heart of the Eeva System is software that was designed to assess critical differences in early embryo growth and determine an embryo’s viability and the potential for further development. The Eeva Test was developed based on landmark research conducted at Stanford University1 which discovered that early embryo growth events can predict embryo development and reflect the underlying health of the embryo. The purpose of the PROSPECT study is to collect data for further development and validation of the Eeva Test.

2014

Protocol: The IVY Study
Sponsor: FINOX
Purpose: Trying to conceiveBetween the ages of 35 and 42 Having regular menstrual cycles Needing in vitro fertilization (IVF) to conceive If so, TFC is currently recruiting patients for the IVY study, an in vitro fertilization research program.

2013

Protocol: Clomiphene Citrate/ IUI Study
Sponsor: Texas Fertility Center
Purpose: Research study involving women 18-35 years of age undergoing treatment with Clomiphene Citrate and intrauterine insemination (IUI). The study is designed to determine if adding progesterone after IUI improves pregnancy rates. Study participants will receive their IUI at no cost. In addition, if they are randomized to the progesterone treatment group, the progesterone will also be provided free of charge. Study participants do not have to get any additional blood work or other laboratory testing.

2011

Protocol: Embryo Biomarker Study
Sponsor: EMD Serono
Purpose: The purpose of the study is to identify and analyze the presence of certain substances (called biomarkers) produced by developing eggs and embryos. It is well known that as eggs and embryos grow, they produce different types of proteins. The amount and types of these proteins differ between normally developing and abnormally developing eggs and embryos. If this study can better characterize these differences, fertility specialists and embryologists may be better able to evaluate an eggs quality or potential for pregnancy in the near future.

2008

Protocol: A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization
Sponsor: Duramed Research, Inc.
Purpose: To study the safety and effectiveness of an experimental progesterone vaginal ring designed to deliver progesterone to support the uterine lining following egg retrieval in IVF cycles. The study was designed to compare pregnancy rates and hormone levels among patients who received the vaginal ring, progesterone in oil (by injection), or a progesterone vaginal gel.

2008

Protocol: A Randomized, Masked Patient, Independent Reviewer, Multi-Center Pilot Study to Evaluate the Feasibility of Sepraspray™ Adhesion Barrier in Laparoscopic Myomectomy
Sponsor: Genzyme Corporation
Purpose: To evaluate an investigational spray (Sepraspray™) that has been developed to prevent the formation of adhesions following laparoscopic surgery. This specific preliminary trial “pilot study” investigated the use of Sepraspray in patients who underwent laparoscopic removal of fibroid tumors of the uterus (leiomyomas). Adhesions, sometimes called “scar tissue”, form as part of the natural healing process that occurs following an injury – such as a surgery. Although normal healing is critical, adhesion formation can cause organs that are usually in close proximity to each other to actually stick together. This can prevent these organs – such as tubes and ovaries – from functioning normally. This study was designed to test whether Sepraspray™ can reduce adhesion formation after laparoscopic fibroid removal.

2008

Protocol: A Phase II, Multicenter, Randomized, Assessor-Blinded, Active comparator, dose finding study to evaluate AS900672-enriched versus follitropin alfa (Gonal-F) in stimulating multiple follicular development in infertile women undergoing Assisted Reproductive Technology (ART).
Sponsor: EMD Serono Inc.
Purpose: To evaluate the safety and effectiveness of an investigational drug designed to stimulate the growth of ovarian follicles as part of ART procedures such as IVF. In this study the investigational drug was compared to an FDA-approved medication GONAL-f®.

2008

Study: A Phase II, Prospective, Randomized Double-Blind, Multicenter, Dose Finding, Comparative Study for the Evaluation of the Aromatase Inhibitor Anastrazole (Multiple-Dose) versus Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women with Ovulatory Dysfunction.
Sponsor: EMD Serono Inc.
Purpose: To determine an effective dose of a new drug, Anastrazole, developed to stimulate follicular growth and ovulation in infertile women who do not ovulate normally. The study assessed 3 different doses of Anastrazole, and compared the response to that of patients receiving Clomiphene Citrate.

2006

Study: A phase IV, multicenter, randomized, double-blinded, clinical trial to confirm the efficacy of the 75 IU dose of Luveris® vs. placebo when administered with follitropin alfa for induction of follicular development and pregnancy in hypogonadotropic hypogonadal women with profound LH deficiency, as defined by a baseline LH level <1.2 IU/L.
Sponsor: Serono Inc
Purpose: To assess the value of giving an LH product (Luveris) in addition to Gonal F to patients who have a rare condition in which they do not make much LH on their own. In this study, all patients received Gonal F. Half were randomized to also receive placebo while the other half received Luveris in addition to Gonal F. Patients’ outcomes were then compared, looking at the number and quality of egg development, as well as serum estradiol production and pregnancy rates.

2005

Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Administered Intravenously or Subcutaneously (via Portable Infusion Pump) Compared to Oral Treatment with Clomiphene Citrate in Anovulatory or Oligoovulatory Infertile Females”
Sponsor: Ferring Pharmaceuticals, Inc.
Purpose: To compare the response of patients who do not ovulate regularly to stimulation with 3 different doses of gonadotropin releasing hormone (GnRH) or clomiphene citrate (Clomid). Clomid is the first line standard treatment for women who do not ovulate regularly. Like Clomid, GnRH acts directly on the pituitary gland in order to induce ovulation. This study was designed to see if one or more of three different doses of GnRH would act as well as or better than clomid.

2005

Study: A Prospective multi center pilot study for the evaluation of an oocyte freezing/thawing method in patients undergoing ICSI
Sponsor: Serono, Inc.
Purpose: To evaluate a new method of freezing and then thawing eggs (oocytes) in women undergoing IVF with ICSI. Oocyte freezing was early in its development at this time, and many different protocols had been proposed to try to optimize the survival and ability of frozen eggs to develop into healthy babies. This study evaluated one of the most popular protocols at the time.

2005

Study: A Prospective, Randomized, Comparative, Single Center Trial to Compare the Safety and Efficacy of Gonal-f RFF versus Gonal-f RFF in combination with Luveris in In-vitro Fertilization
Sponsor: Serono, Inc.
Purpose: To assess the value of giving an LH product (Luveris) in addition to Gonal F to patients undergoing IVF. In this study, all patients received Gonal F. Half were randomized to also receive Luveris. Outcomes were then compared, looking at differences between the two groups in terms of side effects, the number and quality of egg development, serum estradiol production, and pregnancy rates.

2003

Study: A Pivotal, Double-Blind, Comparative, Multicenter Study to Determine the Efficacy and Safety of Adept in the Reduction of Post-Surgical Adhesions after Laparoscopic Surgery”
Sponsor: ML Laboratories
Purpose: To evaluate an investigational liquid (Adept™) developed to prevent the formation of adhesions following laparoscopic surgery. Adhesions, sometimes called “scar tissue”, form as part of the natural healing process that occurs following an injury – such as a surgery. Although normal healing is critical, adhesion formation can cause organs that are usually in close proximity to each other to actually stick together. This can prevent these organs – such as tubes and ovaries – from functioning normally. This large, study investigated the use of Adept in patients who underwent laparoscopic surgery for the removal of fibroid tumors of the uterus, treatment of endometriosis, and/or removal of pelvic adhesions.

2003

Study: Safety and Efficacy Study of N,O-carboxymethylchitosan (NOCC) When Used for Reduction of Postoperative Adhesion Development in Women Undergoing Laparoscopy.
Sponsor: Chitogenics, Inc.,
Purpose: To evaluate the effectiveness of an investigational product (NOCC) developed to prevent the formation of adhesions following laparoscopic surgery.

2003

Study: Prospective, Randomized Phase 2 Study to assess the safety and efficacy of Anastrazole for the induction of ovulation.
Sponsor: Serono Laboratories
Purpose: To determine whether a new type of medication can cause normal ovulation when given to women who do not ovulate regularly. This drug belongs to a class of medications called aromatase inhibitors, and this study was designed to determine not only the effectiveness of this medication, but also to evaluate the type and frequency of any side effects that it causes.

2002

Study: Prospective, Randomized Multi-center two arm double blind study to evaluate the safety and effectiveness of the Spray-Gel Adhesion Barrier System compared to good surgical technique alone in the prevention or reduction of postoperative adhesion formation to the ovaries following laparoscopic gynecologic surgery
Sponsor: Confluent Surgical Technologies
Purpose: To evaluate the effectiveness of an investigational product (Spray-Gel) developed to prevent the formation of adhesions following laparoscopic surgery. In this study, half of the patients received Spray-Gel at the completion of their surgical procedure, whereas the other half underwent a similar surgical procedure but did not receive any adhesion preventative.

2001

Study: A Phase II, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of J867 in Patients with Endometriosis
Sponsor: TAP Pharmaceuticals
Purpose: To evaluate the effectiveness of an investigational product (code named J867) developed to arrest and/or reverse disease progression in patients with documented cases of endometriosis.

1999

Study: A Prospective, Randomized, Comparative Multi- Center Trial to Compare the Safety and Efficacy of Gonal F and Lupron Administered as Single and Separate Injections
Sponsor: Serono Laboratories
Purpose: To evaluate the effect of combining Gonal F and Lupron in the same syringe. Many medications can be altered when mixed in the same syringe together. The physicians at TFC believed that this would not be the case with Gonal F and Lupron and we therefore designed a study to test this hypothesis. Our hope was that, if the drugs could be combined without reducing their effectiveness or causing any adverse reactions, we could reduce the number of injections required of patients undergoing in vitro fertilization.

1999

Study: A Phase I/II Placebo-Controlled Study of the Safety and Efficacy of Recombinant Human Relaxin in Infertile Subjects Undergoing Clomiphene Citrate Therapy
Sponsor: Connetics Corporation
Purpose: To assess the safety and effectiveness of an investigational hormone (relaxin) on improving pregnancy rates in infertile women who were being treated with clomiphene citrate. This study was designed to test previous data that suggested that relaxin might increase the likelihood of implantation.

1999

Study: Assessment of the Safety and Efficacy of Cryo-Ablative Reduction of Menstruation
Sponsor: Ethicon, Inc
Purpose: To evaluate a new minimally invasive surgical method of treating excessive menstrual bleeding through the use of a novel freezing technology. There are several types of surgical and non-surgical treatment designed to reduce menstrual bleeding. Most involve the use of heat and/or electrical current to destroy the uterine lining. This study was designed to assess the effect of freezing the tissue.

1998

Study: A Randomized, Controlled, double-Masked, Multi-Center Pivotal Study to Evaluate ADCON-P Adhesion Control Barrier Solution in the Reduction of Adhesions Following Peritoneal Cavity Surgery.
Sponsor: Gliatech, Inc.
Purpose: To evaluate the effectiveness of an investigational product (Adcon P) developed to prevent the formation of adhesions following pelvic surgery.

1998

Study: A Phase III, Multicenter, Double-Blind, Double Dummy, Randomized, Comparative, Multi-Center Trial To Assess the Safety and Efficacy of Recombinant LH with Profasi in Inducing Final Follicular Maturation and Early Luteinization in Infertile Women Undergoing Ovarian Stimulation with Gonal F Prior to IVF and ET.
Sponsor: Serono Laboratories
Purpose: To compare the safety and effectiveness of a new preparation of luteinizing hormone (LH) with an older formulation of hCG on egg maturity in patients undergoing in vitro fertilization. Profasi (urinary hCG) is a drug developed from human urine using older technology. Luveris (recombinant LH) is a drug with a similar action that is made using newer recombinant DNA technology. This study was designed to see if the two drugs were equally effective at inducing egg maturity in patients undergoing IVF.

1998

Study: An Open-Label, Randomized Multicenter Study to Assess the Efficacy and Safety of Follistim Solution Formulation Compared to a Freeze-Dried Cake Formulation, for the Induction of Ovulation in Clomiphene Resistant Subjects with Chronic Anovulation
Sponsor: Organon Laboratories
Purpose: To compare the safety and effectiveness of a new formulation of Follistim with the standard preparation when given to women with ovulatory dysfunction who had failed to respond to clomiphene citrate.

1998

Study: The Role of an Ultra-Long (3 month) Course Of Depot Lupron Prior to Controlled Ovarian Hyperstimulation (COH) Preparation for in vitro Fertilization/Embryo Transfer in Endometriosis Patients
Sponsor: TAP Pharmaceuticals
Purpose: To determine if it is beneficial to treat patients with extensive endometriosis with Depot Lupron for 3 months prior to their undergoing in vitro fertilization. Following the laparoscopic diagnosis and treatment of endometriosis, one group went immediately into IVF treatment while the other group was treated with Depot Lupron for 3 months before their IVF cycle.

1998

Study: Evaluation of the Efficacy of Interceed Absorbable Adhesion Barrier in Laparoscopic Treatment of Endometriosis
Sponsor: Ethicon Endosurgery
Purpose: To evaluate whether a product already approved by the FDA for the prevention of adhesions in open gynecologic surgery was effective when used in laparoscopic surgery. As most gynecologic surgery was changing from an open to a minimally invasive surgical approach around this time, it was important to determine if this product was effective when used through the laparoscope.

1996

Study: Evaluation of the Safety and Application Techniques of Sepragel Bioresorbable Gel in Open and Laparoscopic Gynecologic Pelvic Surgery
Sponsor: Genzyme Corporation
Purpose: To evaluate the effectiveness of an investigational product (Sepragel) developed to prevent the formation of adhesions following open and/or laparoscopic surgery.