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Baker V.L.,Stanford University | Jones C.A.,IBSA U.S. Operations | Doody K.,Center for Assisted Reproduction | Foulk R.,Idaho Center for Reproductive Medicine | And 9 more authors.
Human reproduction (Oxford, England) | Year: 2014

STUDY QUESTION: Is the ongoing pregnancy rate with a new aqueous formulation of subcutaneous progesterone (Prolutex(®)) non-inferior to vaginal progesterone (Endometrin(®)) when used for luteal phase support of in vitro fertilization?SUMMARY ANSWER: In the per-protocol (PP) population, the ongoing pregnancy rates per oocyte retrieval at 12 weeks of gestation were comparable between Prolutex and Endometrin (41.6 versus 44.4%), with a difference between groups of -2.8% (95% confidence interval (CI) -9.7, 4.2), consistent with the non-inferiority of subcutaneous progesterone for luteal phase support.WHAT IS KNOWN ALREADY: Luteal phase support has been clearly demonstrated to improve pregnancy rates in women undergoing in vitro fertilization (IVF). Because of the increased risk of ovarian hyperstimulation syndrome associated with the use of hCG, progesterone has become the treatment of choice for luteal phase support.STUDY DESIGN, SIZE, DURATION: This prospective, open-label, randomized, controlled, parallel-group, multicentre, two-arm, non-inferiority study was performed at eight fertility clinics. A total of 800 women, aged 18-42 years, with a BMI of ≤ 30 kg/m(2), with <3 prior completed assisted reproductive technology (ART) cycles, exhibiting baseline (Days 2-3) FSH of ≤ 15 IU/L and undergoing IVF at 8 centres (seven private, one academic) in the USA, were enrolled from January 2009 through June 2011.PARTICIPANTS/MATERIALS, SETTING, METHODS: In total, 800 women undergoing IVF were randomized after retrieval of at least three oocytes to an aqueous preparation of progesterone administered subcutaneously (25 mg daily) or vaginal progesterone (100 mg bid daily). Randomization was performed to enrol 100 patients at each site using a randomization list that was generated with Statistical Analysis Software (SAS(®)). If a viable pregnancy occurred, progesterone treatment was continued up to 12 weeks of gestation.MAIN RESULTS AND THE ROLE OF CHANCE: Using a PP analysis, which included all patients who received an embryo transfer (Prolutex = 392; Endometrin = 390), the ongoing pregnancy rate per retrieval for subcutaneous versus vaginal progesterone was 41.6 versus 44.4%, with a difference between groups of -2.8% (95% CI -9.7, 4.2), consistent with the non-inferiority of subcutaneous progesterone for luteal phase support. In addition, rates of initial positive β-hCG (56.4% subcutaneous versus 59.0% vaginal; 95% CI -9.5, 4.3), clinical intrauterine pregnancy with fetal cardiac activity (42.6 versus 46.4%; 95% CI -10.8, 3.2), implantation defined as number of gestational sacs divided by number of embryos transferred (33.2 versus 35.1%; 95% CI -7.6, 4.0), live birth (41.1 versus 43.1%; 95% CI -8.9, 4.9) and take-home baby (41.1 versus 42.6%; 95% CI -8.4, 5.4) were comparable. Both formulations were well-tolerated, with no difference in serious adverse events. Analysis with the intention-to-treat population also demonstrated no difference for any outcomes between the treatment groups.LIMITATIONS, REASONS FOR CAUTION: The conclusions are limited to the progesterone dosing regimen studied and duration of treatment for the patient population examined in this study.WIDER IMPLICATIONS OF THE FINDINGS: Subcutaneous progesterone represents a novel option for luteal phase support in women undergoing IVF who for personal reasons prefer not to use a vaginal preparation or who wish to avoid the side effects of vaginal or i.m. routes of administration.STUDY FUNDING/COMPETING INTERESTS: The study was funded by Institut Biochimique SA (IBSA). CAJ, BC, ST and CJ are employees of IBSA. FH currently consults for IBSA.TRIAL REGISTRATION NUMBER: NCT00828191. © The Author 2014. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.


Williams R.S.,University of Florida | Doody K.J.,Center for Assisted Reproduction | Schattman G.L.,Cornell University | Adashi E.Y.,Brown University
American Journal of Obstetrics and Gynecology | Year: 2015

The clinic-specific public reporting of assisted reproductive technology (ART) outcomes has been mandated by Federal law since 1992. As of late, a series of scientific and medical advances have all but deconstructed ART practice patterns thereby demanding that current reporting platforms be reevaluated for their continued ability to afford the public with credible and understandable estimates of conception per initiated cycle. In this Clinical Opinion, we trace the history of the public reporting of ART, describe the recently modified (present day) reporting platform, and explore potential future improvements thereof. © 2015 Elsevier Inc. All rights reserved.


Doody K.,Center for Assisted Reproduction | Devroey P.,Universitair Ziekenhuis | Gordon K.,Schering | Witjes H.,Schering Plough Research Institute | Mannaerts B.,Schering Plough Research Institute
Reproductive BioMedicine Online | Year: 2010

The possible relationship between endogenous LH concentrations and clinical outcome was evaluated in 750 patients treated with a standardized gonadotrophin-releasing hormone (GnRH) antagonist and recombinant FSH (rFSH)-only protocol. Serum LH concentrations were measured during stimulation by a central laboratory and patients were stratified into quantiles of P75. The P25 values were 3.38 IU/1, 0.93 IU/1, and 0.91 IU/1 on stimulation days 1, 5, and 8, respectively. The ongoing pregnancy rates per started cycle of patients within the P75 subsets and ranged in the various subsets between 35.0% and 39.5%. In keeping with previous, smaller studies, these findings demonstrate that in good prognosis, non-obese patients endogenous LH in a GnRH antagonist protocol is able to support treatment with rFSH only. © 2009, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.


Paulson R.J.,University of Southern California | Fauser B.C.J.M.,University Utrecht | Vuong L.T.N.,University of Medicine and Pharmacy | Doody K.,Center for Assisted Reproduction
Fertility and Sterility | Year: 2016

One of the barriers to access to fertility care is the relative complexity of fertility treatments. If these can be simplified, more patients may be able to take advantage of these treatments. In this overview, we review the potential benefits of simplifying ovarian stimulation by the means of four distinct methods: 1) using mild stimulation for IVF cycles; 2) using in vitro maturation to allow for the retrieval of oocytes that are not yet fully mature yet have the potential to result in live births; 3) conducting IVF in modified natural cycles which use no exogenous FSH stimulation; and 4) allowing embryo culture to take place in a novel intravaginal incubation system. These methods are considered to be somewhat unconventional, yet they have all been shown to lead to live births. In the era of individualized patient care, these techniques present viable alternatives to standard treatment. As experience and outcome data accumulate, they may prove to be not just alternatives to standard treatment, but potentially first-line treatment choices. © 2016 American Society for Reproductive Medicine, Published by Elsevier Inc.


Fatemi H.M.,Universitair Ziekenhuis Brussel | Doody K.,Center for Assisted Reproduction | Griesinger G.,University of Lübeck | Witjes H.,MSD | Mannaerts B.,MSD
Human Reproduction | Year: 2013

Study Question Is the ovarian response to controlled ovarian stimulation (COS) related to the ongoing pregnancy rate when taking into account the main covariates affecting the probabilities of pregnancy following fresh embryo transfer? Summary Answer In patients treated with corifollitropin alfa or daily recombinant FSH (rFSH) in a GnRH-antagonist protocol, a high ovarian response did not compromise ongoing pregnancy rates and increased cumulative pregnancy rates following fresh and frozen-thawed embryo transfer.WHAT IS KNOWN AND WHAT THIS PAPER ADDSA strong association between the number of oocytes and pregnancy rates has been described but this is the first comprehensive analysis assessing important confounders that might affect pregnancy rates. Study Design In a large, prospective, double-blind, randomized trial (Engage; n = 1506), patients were treated with either a single dose of 150 μg corifollitropin alfa or daily 200 IU rFSH for the first 7 days of COS in a GnRH-antagonist (ganirelix) protocol. In this retrospective analysis, patients were categorized into five groups according to the number of oocytes retrieved (0-5, 6-9, 10-13, 14-18 and >18 oocytes). The number of good-quality embryos obtained and transferred, as well as the ongoing pregnancy rates, live birth rates and cumulative ongoing pregnancy rates per started cycle by group were evaluated. Univariate analysis was performed to identify factors that predict the chance of ongoing pregnancy. Logistic regression analysis on the dependent variables ongoing pregnancy and cumulative ongoing pregnancy, respectively, including oocyte category as an independent factor in the model, was performed by treatment group (corifollitropin alfa and rFSH) and overall. The likelihood of ongoing pregnancy and cumulative ongoing pregnancy was then evaluated taking into account ovarian response as well as other identified significant predictors of success.PARTICIPANTS AND SETTINGIn total, 1506 patients had been randomized in a ratio of 1:1 to either of the treatment groups. Patients were aged ≤36 years and had a body weight >60 kg. Main Results and the Role of Chance The ongoing pregnancy rates per started cycle increased in the corifollitropin alfa and rFSH groups from 31.9 and 31.3%, respectively, in the lowest response group (0-5 oocytes) to 41.9 and 43.4% in the highest response group (>18 oocytes) with a significant linear trend (P = 0.04). The cumulative pregnancy rates taking frozen-thawed embryo transfers into account increased from 33.0 and 31.3% to 60.8 and 55.9% in the corifollitropin alfa and rFSH groups, respectively. Univariate logistic regression analyses of ongoing pregnancy showed significant effects for the following factors: embryo transfer (double or single, P < 0.01), region of treatment (North America or Europe, P < 0.01), progesterone level on the day of hCG (>1.5 or ≤1.5 ng/ml, P < 0.01), start day of the stimulation (cycle day 2 or 3, P = 0.02) and age (P = 0.04). Logistic regression analysis of ongoing pregnancy using 10-13 oocytes as the reference category, per treatment group and overall revealed estimated odds ratios (OR) close to 1.0 versus the reference, without statistically significant differences with and without adjustment for significant predictive factors affecting pregnancy rates. Unadjusted OR for cumulative pregnancy reflected significantly lower odds of pregnancy for the lowest response group and significantly higher odds of pregnancy for the highest response group in comparison with the reference. When adjusted for the predictive factors, the cumulative ongoing pregnancy OR (95% confidence interval) of the highest response group versus the reference group was 1.87 (1.34-2.59) when the data of both treatment groups were pooled.BIAS, CONFOUNDING AND OTHER REASONS FOR CAUTIONThe number of covariates included in the final model was limited to five major factors and not all other potentially significant predictive factors were available for evaluation.GENERALIZABILITY TO OTHER POPULATIONSThis analysis is limited to IVF patients with a regular menstrual cycle up to 36 years of age and a body weight >60 and ≤90 kg treated with a GnRH-antagonist protocol and cannot be extrapolated to other patient populations or treatment regimens. Study Funding/Competing Interest (S)Financial support for this study was provided by Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc, Whitehouse Station, NJ, USA. Medical writing and editorial assistance was provided by P. Milner, PhD, of PAREXEL, UK. This assistance was funded by Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Whitehouse Station, NJ. Author conflicts of interest are as follows: H.F. has received honorarium for expert meeting with MSD, lectures for various companies; K.D. has received consultancy fees for Ferring and TEVA Pharmaceutical, payment for lectures and speaker bureaus for Ferring and Watson Pharmaceutical; G.G. has received honoraria as speaker, and served as advisory board member for Ferring, Merck Serono, MSD and IBSA. He has received travel grants from Merck Serono, MSD and grants from Ferring and Merck Serono; H.W. and B.M. are employees of MSD. Trial Registration Numberntc00696800. © 2012 The Author.


News Article | February 22, 2017
Site: motherboard.vice.com

When Sara Hesse was tagged on Facebook last May for a crowdfunding campaign, she hesitated. The project was asking for $4000 up front, to help build a budget fertility clinic in Calgary, which would offer her one round of a sort of do-it-yourself in vitro fertilization treatment in return for her support. She and her husband, Chad, were already on a waiting list at the Regional Fertility Program, the only other clinic in town, which charges around $16,000 for a round of conventional IVF. (Both prices include drug costs.) The couple, in their early thirties, discussed it for about a week. But just one day after the campaign formally opened, they were in. "First and foremost," said Sara in an interview, "it was cost." The Hesses were number 27 on a list of 100 "founder" patients. The first 19 patients signed up on the very first day, and all 100 were on board within 65 days. The clinic, called Effortless IVF, opened its doors to these initial 100 patients on Feb 14. It plans to open to more patients—some 60 more are now in line—in early March, said Jason Broome, the clinic's co-founder and director. Conventional IVF and this newer variant—called intravaginal culture, or IVC—both involve stimulating the ovaries to produce extra eggs, removing the eggs surgically, putting sperm and eggs together artificially and placing nicely-developed embryos into the uterus. But there are some key differences. The most obvious is where fertilization and early embryo development take place. In classic IVF, that happens outside the body. In IVC, all of that takes place inside a woman's body—specifically, inside a little plastic capsule tucked inside her vagina. The 4cm-by-3cm capsule, called an INVOcell, is about the size and shape of an old photographic film canister. Made of polystyrene (just like petri dishes), it is gas-permeable, so appropriate levels of carbon dioxide and oxygen can be maintained inside it by the woman's own body. She also keeps the temperature even and filters out toxins with her liver and kidneys. These are complex and expensive operations when handled by a mechanical incubator, but "effortless" when managed in-house, according to Broome. Under this new protocol, eggs will spend only five minutes co-incubating with sperm outside the body, before being placed into the capsule, with a scrum of sperm hanging onto their outer shells. The INVOcell capsule will remain inside the woman's body, held in place by a diaphragm-like retention device, for five days, during which time winning sperm will declare themselves and embryonic development will kick off. On day five, the capsule is removed, the best one or two embryos are selected for transfer into the uterus, and any remaining good embryos are frozen for future use. The INVOcell, owned by INVO Bioscience in Medford Massachusetts, was approved by Health Canada in 2014 and by the FDA a year later. Not having to pay for 24-hour incubators and all the sensors needed to make sure they are functioning properly accounts for a part of the budget price—which, for post-founder patients, is $6500, plus an administrative fee. But other details about how the clinic will work are different too. Effortless IVF patients, for instance, will not be intensely monitored as they take drugs to promote egg production. Normally, women go for blood tests and ultrasounds every few days, but in this new model, doctors prescribe very low doses of the drugs, based on body weight and a measure of egg volume, and then they schedule a single ultrasound on day 10. Using a lower dose of fertility drugs not only lowers the actual drug costs; it also reduces the risk of complications, and therefore the need for extensive monitoring, said Broome. Other protocols make it possible for the clinic to close on weekends—which also saves money. For instance, all day 10 ultrasounds will happen on a Monday, said Broome, and based on how the eggs are developing on that day, the egg retrieval will be scheduled for either Wednesday, Thursday or Friday that same week. The INVOcell will remain in place for five days after that, meaning that embryos are transferred to the uterus on either a Monday, a Tuesday or a Wednesday the following week. Read More: An Egg Freezing 'Pop-Up Store' Appears in London The clinic places a premium on accessible communications, with payments, appointment bookings, reminders and medical records available online. Broome called it "digital healthcare"—something not common in Canadian fertility medicine. For all the differences, though, ultimate success rates appear to be about the same. Broome, along with Kevin Doody and Kathleen Doody, who are fertility doctors at the Center for Assisted Reproduction in Bedford, Texas, randomly assigned 40 women to receive either IVF or IVC, and placed up to 10 eggs into either an INVOcell or an incubator. Rates of fertilization, pregnancy and live birth were all similar between the groups, they reported last April in the Journal of Assisted Reproduction and Genetics, although classic IVF produced more high-quality embryos. There were 11 successful pregnancies in the IVC group and 12 in the IVF group. The process won't work for everyone. Couples who need intracytoplasmic sperm injection (ICSI) for problem sperm, for instance, won't benefit. Women at risk of overstimulating, such as those with polycystic ovaries, may not want to do their cycles without careful monitoring. Obese women may not fit the bill either. And anyone looking to do genetic testing on their embryos won't get that through this budget clinic. The Calgary clinic—which is a walk-in, with no referral necessary—is the first stand-alone IVC clinic in the world, said Broome. He has plans to bring something similar to Montreal, Toronto and Vancouver. Get six of our favorite Motherboard stories every day by signing up for our newsletter.


Doody K.J.,Center for Assisted Reproduction | Devroey P.,Universitair Ziekenhuis Brussel | Leader A.,University of Ottawa | Witjes H.,Biostatistics and Research Decision science | Mannaerts B.M.,Global Clinical Research
Reproductive BioMedicine Online | Year: 2011

The relationship between endogenous LH concentrations and ongoing pregnancy rates among normogonadotrophic patients undergoing ovarian stimulation in a gonadotrophin-releasing hormone antagonist protocol were examined. In the Engage trial, 1506 patients received corifollitropin alfa (150 μg) or daily recombinant FSH (rFSH) (200 IU) for the first 7 days of stimulation with 0.25 mg ganirelix from stimulation day 5. Patients were retrospectively stratified by serum LH percentiles (<25th, 25th-75th and >75th) on stimulation day 8 and day of human chorionic gonadotrophin administration. Odds ratios (OR) with and without adjustment for predictive factors for ongoing pregnancy were estimated. LH concentration was not associated with pregnancy rates in either treatment arm, in contrast to ovarian response and serum progesterone. With adjustment for these predictors and age, OR (95% confidence interval) for ongoing pregnancy on stimulation day 8 for LH categories P75 versus ≤P75 and P75 were 0.75 (0.53-1.06), 1.26 (0.87-1.83) and 0.70 (0.46-1.09) in the corifollitropin alfa arm and 0.80 (0.54-1.17), 1.28 (0.87-1.87) and 0.73 (0.46-1.16) in the rFSH arm respectively. There was also no significant difference in pregnancy rates between LH categories on day of human chorionic gonadotrophin administration with either treatment. During ovarian stimulation for IVF/intracytoplasmic sperm injection, circulating concentrations of LH should not become too high or too low as the development of mature eggs and the likelihood of ongoing pregnancy may be negatively affected. Gonadotrophin-releasing hormone (GnRH) analogues are applied to prevent premature LH rises but certain regimens may result in relatively low circulating LH concentrations. To examine the relationship between circulating LH concentrations and ongoing pregnancy rates in a GnRH antagonist protocol, data from a large randomized trial, Engage, were retrospectively analysed. In this trial, 1506 patients received corifollitropin alfa or daily recombinant FSH for the first 7 days of stimulation and ganirelix (a GnRH antagonist) from stimulation day 5 onwards. Patients were grouped by their LH concentration (low, normal or high) on stimulation day 8 and the day of human chorionic gonadotrophin (HCG) administration to trigger final egg maturation. The chance of ongoing pregnancy by LH category, with or without adjustment for other factors affecting pregnancy was calculated. There was no significant difference in the chance of pregnancy between patients in the different LH categories, regardless of the day of assessment or the treatment group. In contrast, circulating progesterone (another hormone produced by mature follicles) and the number of eggs retrieved clearly affected the chance of pregnancy. These analyses showed that ongoing pregnancy rates are not influenced by either low or high circulating LH concentrations when using a GnRH antagonist protocol. © 2011, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.


Doody K.J.,Center for Assisted Reproduction
Fertility and Sterility | Year: 2014

Clinics performing assisted reproductive technology (ART) procedures have collected data via registry and publicly reported pregnancy outcomes for more than 25 years. During this time, the practice of ART has changed considerably with frozen embryo transfer (FET) procedures contributing an increasing proportion of live births. Cycles initiated with the intent of embryo banking for the purpose of fertility preservation have been excluded from these public reports, because pregnancy outcomes are not immediately available. An unintended consequence of the common sense handling of fertility preservation has been that cycles performed with intentional short-term cryopreservation of all embryos for other indications have also been excluded from the report. Over the last few years, cryopreservation with short-term delayed transfer increasingly has been performed for reasons other than fertility preservation. The pregnancy outcomes of these cycles are expected within a reasonable time frame and should be transparently reported. The Society for Assisted Reproductive Technology has collaborated with the Centers for Disease Control and Prevention to "recapture" these cycles for the public reports. This recapture is done by linking the FET cycles to the stimulation cycles from which the embryos were derived and by changing the labels of the outcome success metrics. Stimulations using ART, initiated for the purpose of transferring embryos within 1 year will be included in the report despite any prospective intent to freeze all eggs or embryos. A positive outcome will be reported when a live birth results from the first embryo transfer following stimulation ("primary transfer"). Linkage of ovarian stimulation and egg-retrieval procedures to FET will also allow development of other success metrics to further benefit fertility patients. © 2014 by American Society for Reproductive Medicine.


Hossain M.M.,Center for Assisted Reproduction
Mymensingh medical journal : MMJ | Year: 2012

As a good number of couples are coming to infertility clinics to have children at advanced ages, it is essential to know whether advanced paternal age is associated with diminished semen quality and a higher risk of infertility. This retrospective study was done to see the effects of age on semen quality, a well-known indicator of fertility status. Semen parameters of smokers and non-smokers in the study population were also analyzed. A sample of 1121 male partners of infertile couples (aged 25-55 years) who came to an infertility clinic for treatment were included into the study. In addition to clinical history including lifestyle, medical and occupational details and physical examination, their semen samples were examined. Semen volume (ml), sperm concentration (x 10(6)/ml), motility (%), rapidly progressing (%), slowly progressing (%), non-progressive (%) motility and morphology (%) were measured. Semen volume showed IQR 1.5-3.0 ml, and significant decreasing trend with increasing age (r = -0.070, p<0.05). Sperm motility and rapidly progressing motility showed significant decrease (IQR 40.0-70.0, r = -0.115, p<0.01 and IQR 20.0-50.0, r = -0.107, p<0.01 respectively) with increasing age. There was no significant difference between semen parameters of smokers and non-smokers in the study population. This study shown that semen volume, sperm motility and rapidly progressing motility were significantly decreased with increasing age.


Doody K.J.,Center for Assisted Reproduction | Broome E.J.,Kelowna Regional Fertility Center | Doody K.M.,Center for Assisted Reproduction
Journal of Assisted Reproduction and Genetics | Year: 2016

Purpose: The purpose of this study is to to compare the efficacy of intravaginal culture (IVC) of embryos in INVOcell™ (INVO Bioscience, MA, USA) to traditional in vitro fertilization (IVF) incubators in a laboratory setting using a mild pre-determined stimulation regimen based solely on anti-mullerian hormone (AMH) and body weight with minimal ultrasound monitoring. The primary endpoint examined was total quality blastocysts expressed as a percentage of total oocytes placed in incubation. Secondary endpoints included percentage of quality blastocysts transferred, pregnancy, and live birth rates. Methods: In this prospective randomized open-label controlled single-center study, 40 women aged <38 years of age with a body mass index (BMI) of <36 and an AMH of 1–3 ng/mL were randomized prior to trigger to receive either IVC or IVF. Controlled ovarian stimulation was administered with human menopausal gonadotropin (hMG) in a fixed gonadotropin-releasing hormone (GnRH) agonist cycle based solely on AMH and body weight. A single ultrasound-monitoring visit was performed on the 10th day of stimulation. One or two embryos were transferred following 5 days of culture. Results: IVF produced a greater percentage of total quality embryos as compared to IVC (50.6 vs. 30.7 %, p = 0.0007, respectively). There was no significant difference between in IVF and IVC in the percentage of quality blastocysts transferred (97.5 vs. 84.9 %, p = 0.09) or live birth rate (60 % IVF, 55 % IVC). Conclusions: IVF was shown to be superior to IVC in creating quality blastocysts. However, both IVF and IVC produced identical blastocysts for transfer resulting in similar live birth rates. IVC using INVOcell™ is effective and may broaden access to fertility care in selected patient populations by ameliorating the need for a traditional IVF laboratory setting. Further studies will help elucidate the potential physiological, psychological, geographic, and financial impact of IVC on the delivery of fertility care. © 2016 The Author(s)

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