IVF1 Research Studies

IVF1 Clinical Trials

Although we have many effective treatments for couples with infertility, there are still many unanswered questions. At IVF1, we conduct research studies to help answer some of these questions. Our clinical trials involve the use of actual treatments on patients with a variety of different problems. Currently we are conducting studies involving patients with infertility, recurrent miscarriage and those who have failed other treatments such as IVF or frozen embryo transfer.  Click the links below to learn about current studies.

Primary investigator: Hillary Klonoff-Cohen, Ph.D.

Co-investigator: Randy Morris M.D.

NAME OF RESEARCH STUDY: Fertility Preservation and the Role of  AMH

Summary: The purpose of this study is to measure Anti-Mullerian Hormone (AMH) in your blood, which is often used to check a women’s ovarian function and fertility. As a newly diagnosed breast cancer patient, you have the option of undergoing in-vitro fertilization to store your eggs or embryos prior to beginning cancer treatment. Measuring AMH could provide an accurate measure of your future ability to become pregnant after completion of your cancer treatment.

Eligible patients:

1. Reproductive age females (18-45)
2. Newly diagnosed with breast cancer who have not yet undergone chemotherapy, radiation, or surgery,
3. Planning to store oocytes or embryos for fertility preservation.

Exclusions:

1. Patients with other chronic medical conditions such as hypertension or diabetes which is not adequately controlled

Primary Investigator:  Randy Morris M.D.

Status: Recruiting eligible patients

Protocol ID: IVF-03

NAME OF RESEARCH STUDY: A prospective, longitudinal cohort study to investigate the effects of intrauterine infusion of platelet rich plasma (PRP) in women with recurrent pregnancy loss during IVF.

Summary: This study is looking at the effects of effects of intrauterine infusion of platelet rich plasma (PRP) in infertile women with recurrent miscarriage who are attempting pregnancy using IVF. We are trying to determine whether injecting PRP into the uterine cavity (where it will come in contact with the uterine lining) will improve the likelihood of an embryo to continue to develop after implantation.

Eligible patients

In order to participate in this study, you must

1. Have had at least two unexplained, first trimester miscarriages
2. Have completed an evaluation on both male and female partners without any causes for recurrent miscarriage being found
3. Have embryos frozen at the blastocyst stage that are available for transfer
   1. Embryos must be frozen using vitrification
   2. Embryos must be considered high quality as judged by Naperville Fertility Center embryologists
   3. The embryos must be in storage at the Naperville Fertility Center before study enrollment
   4. Embryos may not have been thawed previously
   5. Embryos must have have undergone biopsy and testing for chromosome abnormalities (PGS or preimplantation genetic screening)
4. Prior to study enrollment, demonstrate a normal uterine cavity and absence of hydrosalpinx by hysterosalpingogram, hysteroscopy or laparoscopy with chromopertubation.
5. Have a BMI of less than 30 in order to enroll and must maintain a BMI of less than 30 when estrogen supplementation begins
6. Have normal thyroid function as evidenced by a TSH level in the normal range within two months prior to enrollment.

Exclusions

You may not participate in this study if

1. You have any contraindication to the use of estrogen or progesterone supplementation
2. You have an uncorrected uterine abnormality
3. You have an uncorrected hydrosalpinx
4. You or your partner have other causes for recurrent miscarriage
5. Either you or your partner who produced the embryos have tested positive for either syphilis, hepatitis B, hepatitis C, or HIV AIDS
6. You have taken any non-prescription supplements within one month of enrolling in the study
7. You have uncontrolled diabetes (HbA1c > 6)
8. You have uncontrolled high blood pressure (140/90 despite use of medication)

Primary Investigator:  Randy Morris M.D.

Status: Recruiting eligible patients

Protocol ID: IVF-01

NAME OF RESEARCH STUDY: A prospective, longitudinal cohort study to investigate the effects of intrauterine infusion of platelet rich plasma (PRP) in infertile women with thin endometrial linings during preparation for frozen embryo transfer (FET)

Summary: This study is looking at the effects of intrauterine infusion of platelet rich plasma (PRP) in infertile women with thin endometrial linings during preparation for frozen embryo transfer (FET). We are trying to determine whether injecting PRP into the uterine cavity (where it will come in contact with the uterine lining) will improve the thickness of the lining in women who have previously had problems developing a thick lining.

Eligible patients

In order to participate in this study, you must

1. Have had at least one previous FET attempt using a standard estrogen and progesterone protocol that was cancelled because of a thin uterine lining (< 6 mm) as measured by transvaginal ultrasound
2. Have embryos frozen at the blastocyst stage that are available for transfer
   1. Embryos must be frozen using vitrification
   2. Embryos must be considered high quality as judged by Naperville Fertility Center embryologists
   3. The embryos must be in storage at the Naperville Fertility Center before study enrollment
   4. Embryos may not have been thawed previously
   5. Priority will be given to patients whose embryos have undergone biopsy and testing for chromosome abnormalities (PGS or preimplantation genetic screening)
3. Prior to study enrollment, demonstrate a normal uterine cavity by either saline ultrasound, hysterosalpingogram, or hysteroscopy. A “normal” cavity at the end of an operative hysteroscopy must have follow-up with a subsequent evaluation at a separate time.
4. Have a BMI of less than 30 in order to enroll and must maintain a BMI of less than 30 when estrogen supplementation begins
5. Have normal thyroid function as evidenced by a TSH level in the normal range within two months prior to enrollment.

Exclusions

You may not participate in this study if

1. You have any contraindication to the use of estrogen or progesterone supplementation
2. You have an uncorrected uterine abnormality
3. Either of the partners who produced the embryos have tested positive for either syphilis, hepatitis B, hepatitis C, or HIV AIDS
4. You have taken any non-prescription supplements within one month of enrolling in the study
5. You have uncontrolled diabetes (HbA1c > 6)
6. You have uncontrolled high blood pressure (140/90 despite use of medication)

Clinical Trial: IVF Implantation FailurePrimary Investigator:  Randy Morris M.D.

Status: Recruiting eligible patients

PROTOCOL ID: IVF1-02

NAME OF RESEARCH STUDY: A prospective, longitudinal cohort study to investigate the effects of intrauterine infusion of platelet rich plasma (PRP) in infertile women with recurrent implantation failure.

Summary: This study is looking at the effects of intrauterine infusion of platelet rich plasma (PRP) in infertile women with recurrent implantation failure. We are trying to determine whether injecting PRP into the uterine cavity (where it will come in contact with the uterine lining) will improve the likelihood of an embryo to implant.

Eligible patients

In order to participate in this study, you must

1. Have failed to achieve pregnancy after transfer of
   1. At least two expanded blastocysts that have undergone comprehensive chromosome screening
   2. At least four expanded blastocysts that have not had comprehensive chromosome screening
2. Have embryos frozen at the blastocyst stage that are available for transfer
   1. Embryos must be frozen using vitrification
   2. Embryos must be considered high quality as judged by Naperville Fertility Center embryologists
   3. The embryos must be in storage at the Naperville Fertility Center before study enrollment
   4. Embryos may not have been thawed previously
   5. Priority will be given to patients whose embryos have undergone biopsy and testing for chromosome abnormalities (PGS or preimplantation genetic screening)
3. Prior to study enrollment, demonstrate a normal uterine cavity and absence of hydrosalpinx by hysterosalpingogram, or laparoscopy with chromopertubation.
4. Have a BMI of less than 30 in order to enroll and must maintain a BMI of less than 30 when estrogen supplementation begins
5. Have normal thyroid function as evidenced by a TSH level in the normal range within two months prior to enrollment.

Exclusions

You may not participate in this study if

1. You have any contraindication to the use of estrogen or progesterone supplementation
2. You have an uncorrected uterine abnormality
3. You have an uncorrected hydrosalpinx
4. Either you or your partner who produced the embryos have tested positive for either syphilis, hepatitis B, hepatitis C, or HIV AIDS
5. You have taken any non-prescription supplements within one month of enrolling in the study
6. You have uncontrolled diabetes (HbA1c > 6)
7. You have uncontrolled high blood pressure (140/90 despite use of medication)

Clinical Trial: Treatment to Improve Ovarian ReservePROTOCOL NUMBER: IVF1-04

NAME OF RESEARCH STUDY: A prospective, longitudinal cohort study to investigate the effects of ovarian platelet rich plasma (PRP) injection in women with poor ovarian reserve

PRINCIPAL INVESTIGATOR:Randy  S Morris M.D.

Summary: This study is trying to determine whether injection of platelet rich plasma (PRP) into the ovaries of infertile women with decreased ovarian reserve will result in activation of ovarian stem cells and result in the production of healthy new eggs.

Eligible patients
In order to participate in this study, you must

1. Be under the age of 40
2. Have a history of infertility and be currently attempting pregnancy
3. Be pre-menopausal as evidenced by still having menstrual cycles
4. Have decreased ovarian reserve
   1. Low levels of AMH
   2. High levels of FSH on day 2 or 3 of the menstrual cycle
   3. Low antral follicle count on transvaginal ultrasound on day 2 or 3 of the menstrual cycle
5. Have a BMI of less than 30
6. Have normal thyroid function as evidenced by a TSH level in the normal range within two months prior to enrollment.

Exclusions

You may not participate in this study if you

1. Are using any form of contraception
2. Have previously had surgery on your ovaries
3. Have undergone chemotherapy or radiation at any time in the past
4. Have been diagnosed with Premature Ovarian Failure
5. Have ovaries that are inaccessible by transvaginal ultrasound
6. Have used any herbal or nutritional supplements other than prenatal vitamins in the previous 6 months
7. Have any contraindications to anesthesia
8. You have uncontrolled diabetes (HbA1c > 6)
9. You have uncontrolled high blood pressure (140/90 despite use of medication)