Our accomplished fertility research program conducts numerous clinical trials as part of a commitment to developing innovative technologies and improved fertility success rates.
Patients who qualify for these trials often take advantage of discounted treatments and medications.
To inquire about participating in a fertility study, please submit an email inquiry to our Research Program Manager (Kristin Rooney) or contact her by phone at 781-434-6470.
STUDY #1: Discarded Embryos
Stem cells are cells that have the remarkable potential to develop into many different cell types. Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition.
Boston IVF is collaborating with a company that is performing research on developing clinical applications of stem cell therapy for diabetes and other illnesses. This project is being conducted under the approval of an ethical research committee.
In an IVF cycle the patient will have embryos used for their own treatment [transfer or freezing] and the remaining poor quality embryos are discarded. To develop these stem cell therapies we will ask patients to donate only their poor quality embryos that would normally be discarded. If successful this project would have the ability to assist a significant amount of people.
STUDY #2: IVF
Boston IVF is seeking couples to participate in a fertility research study designed to compare the success of the in vitro fertilization (IVF) procedure including the number of high-quality embryos. Sperm will be prepared with a standard IVF sperm preparation protocol and with an investigational protocol using the Ohana IVF sperm preparation kit
You may be eligible for the study if you:
- Are between 25 to 37 years old
- Have a BMI of 21-35 kg/m2
- Have regular menstrual cycle of 25 to 35 days
- History of infertility ≥ 12 months
- Do not have history of recurrent pregnancy loss (more than 2)
All qualified study participants will undergo an IVF cycle with preimplantation genetic testing for aneuploidy (PGT-A) and frozen embryo transfer (FET). Some of the study related procedures and visits will be provided at no charge or a discounted rate. Participants may be responsible for paying a portion of the IVF cycle fees. If so, the study center/clinic will review these costs with you in detail.
To inquire about participating in an active research study, please complete the inquiry form below and our Research Program Manager (Kristin Rooney) will contact you shortly.
PAST RESEARCH & PUBLICATIONS
MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle w/Single-Blastocyst Transfer in a High Responder Subject Population (MEGASET HR)
ClinicalTrials.gov Identifier: NCT02554279
Boston IVF saught patients to participate in a fertility research study designed to compare two medications used for controlled ovarian stimulation (COS), in in vitro fertilization (IVF) cycles.
Single Embryo Transfer of Euploid Embryo (STAR)
ClinicalTrials.gov Identifier: NCT02268786
The purpose of the current study was to evaluate the effect of preimplantation genetic screening (PGS) by next generation sequencing (NGS) compared to standard morphological assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All embryos were vitrified and a single embryo transfer (SET) was performed with either screened or unscreened embryos depending on randomization.
ClinicalTrials.gov Identifier: NCT02040545
The Saliva Study aimed to identify how well a saliva test works for monitoring hormone levels during treatment for infertility - in effort a more “patient-friendly” option for fertility treatment associated with less blood draws, fewer visits, and decreased stress and discomfort during treatment.
The Impact of Lifestyle Behaviors on In Vitro Fertilization (IVF) Outcome
ClinicalTrials.gov Identifier: NCT01119391
Many women undergoing in vitro fertilization (IVF) ask their doctor if there are any behaviors they should avoid, or any behaviors they should emphasize during their IVF cycle. This study examines the effects of health habits surrounding exercise, smoking, alcohol, sleep, caffeine, herbal medications, acupuncture, and diet on pregnancy rates during IVF cycles. The purpose of this study is to determine if lifestyle behaviors have a significant impact on pregnancy rates during treatment with IVF.
The Impact of Lifestyle Behavior on in Vitro Fertilization (IVF) Outcome – eIVF Survey Study
ClinicalTrials.gov Identifier: NCT01404858
The purpose of this study is to prospectively examine the impact of various lifestyle habits in both men and women on the outcome of in vitro fertilization. There are 25 infertility centers in the United States which use the electronic medical record collection entity eIVF, made by Practice Highway, to collect medical and demographic information on the patients who are undergoing treatment at these centers. Information on every aspect of each cycle is also electronically collected daily during each cycle. Demographic and lifestyle information will be collected on all patients prior to cycle start and lifestyle habit information will be collected each time a patient logs onto the patient portal, which averages every few days.
The Impact of Distress on the IVF Outcome
ClinicalTrials.gov Identifier: NCT01103973
Stress is a primary reason why in vitro fertilization (IVF) patients drop out of treatment, and it may have a detrimental impact on pregnancy rates, yet there is minimal published research on the efficacy of structured skills-based psychological interventions with assisted reproductive technology patients. The objective of this study was to determine if women who are randomized to a mind/body program prior to starting their first IVF cycle would have higher pregnancy rates than controls.
Effect of Psychological Intervention on Drop-out Rates in IVF
ClinicalTrials.gov Identifier: NCT01318291
The most common reason why insured IVF patients drop out of treatment is the distress caused by the treatment. The objective of this study was to determine the efficacy of a combined Cognitive Coping and Relaxation Intervention (CCRI) in reducing drop out behavior in IVF patients.
Frozen Embryo Donation Study (FREDS)
ClinicalTrials.gov Identifier: NCT01883934
It is estimated that over 600,000 cryopreserved embryos are stored in the U.S. The disposition of these embryos becomes a tormenting decision for many IVF patients and embryo donation remains largely underutilized. This study aimed to assess the baseline knowledge and attitudes of IVF patients regarding frozen embryo donation. Next, a clinic-based procedural intervention was developed and implemented with the aim of enhancing the awareness and likelihood of embryo donation for procreation.
Conventional Infertility Treatment vs. Fast Track to IVF (FASTT)
ClinicalTrials.gov Identifier: NCT00260091
The purpose of this randomized prospective clinical trial was to determine whether an infertility treatment that moves quickly to IVF is more cost effective than the usual treatment strategy which includes various combinations of infertility drugs and intrauterine insemination (IUI) prior to utilizing In Vitro Fertilization.
Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029) (PURSUE)
ClinicalTrials.gov Identifier: NCT01144416
The purpose of this study is to show that a single injection of SCH 900962/MK-8962 is non-inferior to daily injections of recombinant follicle-stimulating hormone (recFSH) during the first week of ovarian stimulation in terms of the number of vital pregnancies (ie, presence of at least one fetus with heart activity as assessed by ultrasound at least 35 days after embryo transfer) in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)
ClinicalTrials.gov Identifier: NCT01146418
The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF Failures (Thrive-IVF) (Thrive-IVF)
ClinicalTrials.gov Identifier: NCT01864356
The purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of subcutaneous NT100 vs placebo following in vitro fertilization (IVF) in women with a history of repeated IVF failures.
Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT (NIMO)
ClinicalTrials.gov Identifier: NCT01672801
The main purpose of this study is to test the effectiveness of nimodipine in preventing a luteinizing hormone (LH) surge in women undergoing ovulation induction with clomiphene citrate. It is important to prevent the premature LH surge in controlled ovarian stimulation to allow adequate recruitment of follicles, proper maturation of a dominant follicle before ovulation, and effectively time insemination with semen to allow fertilization of a mature egg to occur. The investigators are also conducting this study to determine medication side effect profile (including lightheadedness or dizziness from low blood pressure or rapid heart rate, headache, and nausea), patient treatment compliance, and clinical pregnancy (positive pregnancy test and ultrasound evidence of fetal heart rate). Finally, LH and follicle stimulating hormone (FSH) serum levels will be measured to determine effect of nimodipine on these hormones. As a calcium channel blocker, nimodipine has been shown to block calcium mediated release of gonadotropin releasing hormone in animal and preliminary human studies. The investigators hypothesize that nimodipine, a calcium channel blocker, will prevent or delay the LH surge during controlled ovarian stimulation cycles using clomiphene citrate in subfertile patients undergoing assisted reproduction with intrauterine insemination (IUI).
Impact of Parental Support on Pregnancy Outcomes (IPSO) Trial- Day 3 Preimplantation Genetic Screening (PGS) With Day 5 Fresh Transfer (IPSO)
ClinicalTrials.gov Identifier: NCT01194531
The purpose of this study is to determine whether PGS- testing of embryos created during IVF for chromosomal abnormalities, prior to transfer to the uterus- improves pregnancy and implantation rates in patients when compared to patients whose embryos are not tested. PGS will be conducted using 24 Chromosome Aneuploidy Screening with Parental Support from Natera.
Oocyte Cryopreservation Registry (HOPE Registry)
ClinicalTrials.gov Identifier: NCT00699400
Phase IV, prospective multicenter, observational Registry will track cycle outcomes for subjects who are thawing frozen oocytes for subsequent use through in vitro fertilization (IVF) and embryo transfer (ET)
Infertility Therapy for Women Age Thirty-eight and Older (FORT-T)
ClinicalTrials.gov Identifier: NCT00246506
This study will determine the most effective treatment strategy for infertile couples who present when the female partner is 38 years to the 43rd birthday and the couples are determined to have a reasonable chance for success.
A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization
ClinicalTrials.gov Identifier: NCT00615251
This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.
ASRM 2015 ABSTRACTS
All abstracts are available at http://scientific.asrmcongress.org/Portals/1/2015PDFs/abstracts.pdf; each abstract page # listed with abstract citation
AN EXPLORATORY RANDOMIZED TRIAL ON THE EFFECT OFA BRIEF PSYCHOLOGICAL INTERVENTION ON EMOTIONS, QUALITY OF LIFE, DISCONTINUATION AND PREGNANCY RATES IN IVF PATIENTS
A. D. Domar,a J. Gross,a K. Rooney,a J. Boivin.b aDomar Center for Mind/Body Health, Boston IVF, Waltham, MA; bCardiff Fertility Studies Research Group, School of Psychology, Cardiff University, Cardiff, United Kingdom. (page 41)
MONOZYGOTIC TWINNING IN IVF: WHY DO THEY CLUSTER?
D. A. Vaughan,a R. Ruthazer,b A. Penzias,c E. Norwitz,a D. Sakkas.d aOBGYN, Tufts Medical Center, Boston, MA; bClinical and Translational Research Department, Tufts Medical Center, Boston, MA; cBeth Israel Deconness Hospital/Boston IVF, Waltham, MA; dBoston IVF,Waltham, MA. (page 93)
EFFICIENCY OF CRYODEVICE IN EGG BANKING: IS ONE DEVICE SUPERIOR THAN OTHERS?
Lim,a R. Holmes,b T. O’Leary,c J. Liebermann,d E. Magno,e A. Brewer,f J. Graham,a M. Tucker.a aShady Grove Fetility, Rockville, MD; bBoston IVF, Waltham, MA; cCoastal Fertility Specialists, Mount Pleasant, SC; dFertility Centers of Illinois, Chicago, IL; eFertility Center of Illinois-Highland Park, Highland Park, IL; fFertility Institute of Hawaii, Honolulu, HI. (page 187)
IVF PROVES COST EFFECTIVE COMPARED TO MINIMAL STIMULATION EMBRYO TRANSFER, BUT MINIMAL STIMULATION IS A COST NEUTRAL ALTERNATIVE FOR WOMEN UNDER AGE 35
N. Resetkova,a K. C. Humm,b A. Penzias,c D. Sakkas,d B. M. Lannon.e aObstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA; bObstetrics and Gynecology, George Washington University School of Medicine, Washington, DC; cBoston IVF / Harvard Medical School, Waltham, MA; dBoston IVF, Waltham, MA; eBoston IVF, South Portland, ME. (page 205)
THE LACK OF IMPACTOF AGE ON TREATMENT TERMINATION IN INSURED IVF PATIENTS
D. Sakkas,a L. Dodge,b M. R. Hacker,b A. D. Domar.a aBoston IVF, Waltham, MA; bDepartment of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA. (page 208)
CHANGES IN SINGLETON LIVE BIRTH WEIGHTS IN A LARGE IVF PRACTICE OVER AN 18 YEAR PERIOD
K. Maas,a,b E. Galkina,c K. Thornton,a,b D. Sakkas.b aBeth Israel Deaconess Medical Center, Boston, MA; bBoston IVF, Waltham, MA; cBiomedical Engineering and Biotechnology, University of Massachusetts Lowell, Lowell, MA. (page 214)
WOMEN’S ALCOHOL CONSUMPTION AND FIRST CYCLE IN VITRO FERTILIZATION OUTCOMES
E. Dodge,a,b S. A. Missmer,c,b,d K. L. Thornton,e,b M. R. Hacker.f,b,d aObstetrics and Gynecology, Boston, MA; bObstetrics, Gynecology and Reproductive Biology, Harvard Medical School, Boston, MA; cBrigham andWomen’s Hospital and Harvard Medical S, Boston, MA; dEpidemiology, Harvard School of Public Health, Boston, MA; eBoston IVF, Waltham, MA; fBeth Israel Deaconess Medical Center, Brookline, MA. (page 221)
SUCCESS RATES OF RESCUE ICSI AND ANALYSIS OF EMBRYO CLEAVAGE RATES BY REAL TIME VIDEO IMAGING
P. Jarmuz,a O. Ocali,a M. Baldwin,a D. Sakkas,b C. Barrett.b aEmbryology, Boston IVF, Waltham, MA; bBoston IVF, Waltham, MA. (page 301)
ANEUPLOIDY RATES IN EMBRYOS PRODUCED BY FERTILE COUPLES
D. Wells,a K. Ravichandran,b M. Alper,c J. Jain,d A. Penzias,e C. A. Benadiva,f P. Colls,b M. Konstantinidis,b S. Munne.b aReprogenetics, Oxford, United Kingdom; bReprogenetics, Livingston, NJ; cBoston IVF, Waltham, MA; dSanta Monica Fertility, Santa Monica, CA; eBoston IVF / Harvard Medical School, Waltham, MA; fUniversity of Connecticut, Farmington, CT. (page 307)