Clinical trials
Through participation in various clinical trials, the physicians and scientists at Shady Grove Fertility continually strive to stay at the forefront of research and technology—to advance medical knowledge and improve patient care. Clinical trials are research studies that investigate whether a medical strategy or treatment approach is safe and effective. They also provide invaluable insights into which strategies and treatments work best. At Shady Grove Fertility, we follow strict scientific protocols to ensure patient safety and help produce reliable study results.
We encourage our patients to learn more about our ongoing trials, as they offer unique advantages, including, in some cases, free or discounted access to new treatments before they’re widely available. If you choose to participate in a clinical trial, you may receive the new approach being tested. At Shady Grove Fertility, as always, you will have the support of your physician and health care team.
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Active clinical trials and research studies
Reproductive Window Study (Enrollment closed)
Are you female between the ages of 18 to 40? Have you had a cancer diagnosis and cancer treatment? If so, the Reproductive Window Study needs you! The research team at Shady Grove Fertility, in collaboration with the researchers at UC San Diego, want to know how cancer treatment affects the reproductive health of young adult female cancer survivors. Participants will be followed for 18 months and asked to complete study activities at FOUR specific time points. Participants will receive a $10 gift card after completing each study activity.
If you are interested in learning more about this study, please visit www.youngcancersurvivor.com or contact us at 858-822-0768 or [email protected].
UCSF Aspire Research Study (Enrollment closed)
Shady Grove Fertility is partnering with the University of California San Francisco to conduct the UCSF ASPIRE research study. This study looks at the implications of COVID-19 exposure during pregnancy and to promote the health and safety of pregnant women and their babies everywhere. UCSF ASPIRE seeks to collect data on pregnancies during this unprecedented pandemic, starting from the earliest stages of fetal development. Any pregnant women between 4-10 weeks gestation is eligible to enroll in the UCSF ASPIRE study.
To participate or learn more, please visit https://aspire.ucsf.edu or email your contact information to [email protected], and a study coordinator will be in touch regarding enrollment for the UCSF ASPIRE study.
Colorado Research Study on Heart Health after IVF
We are inviting women to participate in a research study trying to understand why women may go on to develop high blood pressure after a pregnancy with IVF.
ELIGIBILITY
- Age 18 – 45 years
- Prior pregnancy within past 1 – 5 years, conceived through IVF
- Not currently taking medications to treat high blood pressure or cholesterol
- Not currently pregnant or wishing to become pregnant in the next 3 months
If interested, complete the optional eligibility survey: https://redcap.link/vfd7htql
Compensation provided
PREGnant Study
This study aims to investigate efficacy of an embryo transfer with 60-days of Orilissa treatment in patients with endometriosis. The study provides Orilissa free of charge in addition to $100 upon completion of study visits.
Eligibility:
- Confirmed endometriosis diagnosis
- Planning to do IVF with embryo transfer
Involvement:
- Up to 5 study visits that entail filling out questionnaires, doing blood draws, and pregnancy tests.
- Willing to take Orilissa (non-medicated part of the study is also available)
- Willing to allow for data collection for cycle parameters.
If you have any questions or would like to know more, please contact Asma Giornazi at [email protected] or 720-276-8941.
Considering IUI? Undergoing IUI?
The purpose of this study is to assess the accuracy of a new, non-invasive sperm test for IUI patients.
Get $100 in compensation for your participation in a clinical study happening NOW at Shady Grove Fertility.
What’s Involved?
- The male partner will provide a semens sample either at the clinic or by
using a discreet at-home collection kit - A $100 gift card will be emailed after the semen sample is received and a short survey is completed
- The participant may be contacted by Shady Grove regarding testing outcomes
- Nothing further is required for participation in this study
If you are interested in participating: please email [email protected] or call 720-704-8221.
A team member from Shady Grove or the study sponsor, Inherent Biosciences, will contact you to provide formal consent and facilitate collection and compensation.
Natpro
Multi-center, parallel-group, randomized controlled trial of modified natural verses programmed cycles for frozen embryo transfers and their association with preeclampsia and live births. Shady Grove Fertility is currently seeking patients to participate in a fertility research study designed to compare two protocols commonly used for frozen embryo transfer. The two protocols are called “modified natural cycle” and “programmed cycle”. The study will examine whether or not there is a difference in occurrence of high blood pressure during pregnancy.
You may be eligible for the study if you:
- Age 18-41 years at the time of randomization
- Have a Body Mass Index (BMI) ≤ 40
- Have a regular menstrual cycle of 24 to 35 days
Participants will be compensated for their time and effort up to $1415 if they complete all visits and participate in the research study.
Please contact your physician, nurse or our clinical research team to determine if you are eligible to participate at 301-545-1423 or [email protected].
ALLEVIATE (Enrollment closed)
Shady Grove Fertility is currently seeking patients to participate in a study to determine
if a medication can improve pain control after undergoing egg retrieval. This medication
is the nonsteroidal anti-inflammatory drug (NSAID), Ketorolac (Toradol). This study will
examine whether or not there is a difference in pain control following egg retrieval when
given this medication.
Eligibility:
- Female age over 18 years old
- Planning to undergo first oocyte retrieval and fresh embryo transfer
- BMI < 40 kg/m2
Please contact your physician, nurse, or our clinical research team to determine if you
are eligible to participate at (301) 545-1423 or
[email protected].
Life Whisperer Oocytes Study (Rockville) (Enrollment closed)
Development of a non-invasive, artificial intelligence-based image analysis software for the prediction of oocyte developmental competency during in vitro fertilization.
The purpose of the proposed research study is to determine if a software algorithm can be developed to analyze images of oocytes during IVF. The proposed algorithm will use artificial intelligence to identify which oocytes are more likely to develop into a good quality embryo. The ability to turn into a good quality embryo is called developmental competence.
Participants in this study will be women who undergo IVF procedures including in vitro fertilization of oocytes. This is a non-interventional study, meaning the algorithm will not be used during your participation in the study, and it will not have any impact on your treatment. Your participation will just involve collecting information about what happens to your oocytes during your IVF procedures.
Eligibility
- You must be at least 18 years of age and have decided to undergo IVF procedures.
- You can either:
- Undergo oocyte harvest and fertilization using fresh oocytes, or
- Use oocytes that you had previously frozen, or
- Use donor oocytes that had previously been frozen.
- If you are undergoing oocyte harvest and fertilization using fresh oocytes, you must be planning to use intracytoplasmic sperm injection (ICSI) for fertilization. This is a process where oocytes are individually injected with sperm. ICSI is performed on all oocytes that have previously been frozen.
- If you are undergoing oocyte harvest, you must not be planning to freeze your oocytes for a long time for fertilization at a later date (this is called ‘fertility preservation’).
Please contact your physician, nurse or our clinical research team to determine if you are eligible to participate at 301-545-1423 or [email protected].
More information about Life Whisperer is available here: www.lifewhisperer.com
Arias Research Study (Enrollment closed)
Shady Grove Fertility is conducting the ARIAS Research study to evaluate whether sperm DNA fragmentation is associated with IVF-ICSI outcomes. DNA fragmentation testing of sperm will be provided to participants free of charge.
You may qualify to participate if you and your partner meet the following eligibility criteria:
- Planning to use fresh (not previously frozen) sperm
- Have never been told your partner has no sperm on semen analysis
- No history of chromosomal abnormalities in yourself or your partner
- No history of a varicocele in your partner
- No current tobacco use by you or your partner
Please contact your physician, nurse or our clinical research team to determine if you are eligible to participate at 301-545-1423 or [email protected].
PROGRESS (Chesterbrook)
Shady Grove Fertility is currently seeking women to participate in a fertility research study to look at whether an investigational Progesterone preparation administered as an injection under the skin is safe and effective in supporting the implantation and early pregnancy following frozen euploid transfer (FET) in comparison to Crinone, a progesterone administered vaginally.
You may be eligible for the study if you:
- Have a euploid (normal) embryo from a previous IVF cycle or if you are a candidate for FET
- Are between 35 to 42 years old
- Have a BMI of <38 kg/m2
- Consistent, regular spontaneous ovulatory menstrual cycle with normal length (24-38 days included)
- Do not have history of recurrent pregnancy loss (2 or more)
If you are a candidate for the study, the study drugs will be provided at no cost to you. Candidates who do not have a frozen euploid embryo from a prior IVF cycle will receive genetic testing for their embryos at no cost. Study subjects who undergo FET will receive a credit of $7,500 applied to their Shady Grove balance.
To learn more information about the PROGRESS fertility research study and if you qualify for the study: please contact your physician or your clinical team, or email our Pennsylvania research coordinator at [email protected].
ProteX
Key participation requirements:
- SGF couple undergoing IVF with a fresh (not frozen) semen specimen
- Motility from semen analysis >15%
- No history of azoospermia
- No need for surgical aspiration of sperm (TESE or mTESE)
- Clear Lake patients collect like they normally would in the office on retrieval day; other SGF Houston area patients would collect in the ProteX cup at home prior to arriving at the clinic on retrieval day
- Regardless of location, all candidates will receive a pre-paid $50 Visa Gift Card
If you are interested in learning more, please contact Cara for more information.
Email: [email protected], Call: 832-342-9129
elaris EM-COC
The elaris EM-COC Study is evaluating whether the study medication, when taken together with an approved birth control pill, may reduce moderate-to-severe endometriosis pain.
You may qualify if you:
- Are a premenopausal woman, 18 to 49 years old
- Have had a surgical diagnosis of endometriosis
- Have moderate-to-severe endometriosis pain
- Do not use nicotine or have a history of smoking (if 33 years or older)
- Are not pregnant, actively trying to get pregnant, or are breastfeeding
- Do not have hepatitis B, hepatitis C, or other liver disease
- Do not have osteoporosis (thinning, weak bones) or any other bone disease
For more information or to see if you may qualify, visit https://www.endometriosis-study.com/ or contact our Houston clinical research coordinator, Cara Barrier, at 832-342-9129 or [email protected].
femaSeed Localized Directional Insemination Clinical Study (Enrollment closed)
This study is currently enrolling women who want to become pregnant through artificial insemination.
You may be eligible for this study if:
- You are a female between the ages of 19-40
- You do not have an infertility factor, including blocked fallopian tubes, or uterine or ovarian issues
- Your male partner has male infertility
For more information or to see if you may qualify, visit www.FemaSeed.com or contact our Houston clinical research coordinator, Cara Barrier, at 832-342-9129 or [email protected].
SERENE (Enrollment closed)
The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.
To be eligible for this study, you must:
- Be a premenopausal woman 18 to 50 years of age and have normal, regular menstrual cycles that are between 21 and 35 days
- Be sexually active and have requested contraception (birth control) from your doctor to avoid pregnancy (to be considered “sexually active” in this study you must be having vaginal intercourse at least once per month with a male partner who is not known to be infertile)
- Have a diagnosis of either uterine fibroids with heavy menstrual bleeding or endometriosis with associated moderate to severe pain
- Be willing to use an investigational product as the sole method of contraception for one year (for example: condoms, diaphragms, and withdrawal are not allowed)
- Agree to complete a daily electronic diary (eDiary)
This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you.
For more information or to see if you may qualify, visit https://classic.clinicaltrials.gov/ct2/show/NCT04756037 or contact our Houston clinical research coordinator, Cara Barrier, at 832-342-9129 or [email protected].
Adam Idiopathic Infertility Trial
ADAM is a trial investigating the efficacy and safety of treatment with FE 999049 in men with Idiopathic Infertility to assess the chance of improved spontaneous pregnancy in their current female partner.
Key participation requirements:
- Male participant must be aged 18-50 years old; Current female partner must be aged 18-35 years old
- Commitment: Male participant will visit the trial site 8 times for tests and procedures
- Male participant must have documented infertility for 12-60 months with current female partner
- Male participant & current female partner cannot obtain infertility treatment outside of this trial for 9 months from enrollment
- Male participant must not have a Body Mass Index >35 kg/m2
- Male participant must not have history of drug abuse within 12 months prior to screening
If you are interested in learning more, please contact Cara or Maryanne for more information.
Email: [email protected], Call: 832-342-9129
Email: [email protected], Call: 281-557-3082
To learn more about the ADAM Idiopathic Infertility Trial, visit clinicaltrials.gov here.
PROGRESS
The PROGRESS Study is an investigational study to determine if Progesterone-IBSA administered as an injection under the skin (subcutaneous) is safe and effective in supporting the implantation and early pregnancy following a frozen embryo transfer (FET).
You may be eligible for the study if you fall into one of the following two categories:
- You are undergoing or plan to undergo an ovarian stimulation treatment to produce multiple oocytes (eggs) and are interested in preimplantation genetic testing for aneuploidy (PGT-A) for the embryos
- You have already undergone an ovarian stimulation in the past and have a frozen euploid embryo and you qualify for a frozen embryo transfer (FET)
And meet the following criteria:
- Age 35-42
- Are planning a single frozen embryo transfer
- Have regular menstrual cycles (24-38 days)
- Do not have history of recurrent pregnancy loss (2 or more consecutive losses)
- Have a BMI of <38kg/m2
For more information or to see if you may qualify, visit https://clinicaltrials.gov/study/NCT04549116 or contact our Houston clinical research coordinator, Cara Barrier, at 832-342-9129 or [email protected].
HerResolve by Heranova
At this point in time, surgery is the only confirmation that providers have to diagnose a patient with endometriosis. Endometriosis is also often misdiagnosed or diagnosed much later after initial onset of symptoms. The study’s purpose is to determine if a biomarker can be used to confirm the presence of endometriosis. This blood draw would allow for a less invasive method to determine if endometriosis is present, with surgery being used to define the stage of endometriosis. This would also allow for a quicker and more accurate diagnosis.
Criteria for potential candidates:
- Age 18 – 50, sexually active
- Infertility, abdominal pain, and abnormal bleeding symptoms
- Suspected endometriosis with surgery planned or confirmed endometriosis (via surgery or pathology report)
- Negative for pregnancy
- Negative for autoimmune diseases (such as HIV and Lupus), Hepatitis B, Hepatitis C, genital infections, oral infections, and STIs
- Negative for cancer (at least 4 weeks post-treatment)
Enrolled patients will receive a $200 gift card.
For more information, contact our Houston clinical research coordinator, Cara Barrier, at 832-342-9129 or [email protected].
