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Zygote Intrafallopian Transfer (ZIFT) versus In Vitro Fertilization (IVF) - Embryo Transfer for Patients of Advanced Maternal Age

Primary Aims: To determine whether ZIFT improves clinical pregnancy rates in women of advanced maternal age compared to IVF with traditional intrauterine transfer.

Study Design
We will perform a prospective, randomized crossover study. Once eligibility is determined, those who choose to enroll will randomly be assigned to one of two treatment groups. The first group will undergo one cycle of ZIFT followed by a cycle of IVF should pregnancy not occur during the first cycle; the second group will undergo a cycle of IVF followed by a ZIFT cycle should pregnancy not occur in the first cycle. Our aim is to enroll a total of 60 patients (30 in each group) into this study.

Inclusion Criteria:

1. Between 38 and 45 years of age
2. Day 3 FSH ≤ 15 mIU/mL (hormone testing)
3. Presence of at least one normal fallopian tube
4. Normal uterine cavity, as defined by the program
5. Normal body mass index (BMI ) <30
6. No history of ectopic pregnancy
7. No history of prior tubal surgery
8. Normal endocrine workup

 
Exclusion Criteria:

1. Couples using donor oocytes
2. Couples using frozen oocytes
3. Uncorrected hydrosalpinx (dilated fallopian tubes)
4. Uncorrected abnormal uterine cavity
5. History of complications related to tolerance to birth control pills, gonadotropins, estrogen or progesterone
6. Smoker at the time of enrollment
7. Any medical condition that is contraindicated to pregnancy or gonadotropin therapy (ie. allergies, immune deficiency, etc)


FAQs
:

What is ZIFT?
ZIFT is a laparoscopic operative procedure that is performed under general anesthesia. The procedure requires two 1 cm incisions; one inside the belly button, the other at the bikini line. Under direct visualization, the embryos are inserted via a catheter into one of the fallopian tubes. The entire procedure takes approximately 30 minutes.

How are the embryos transferred during a routine IVF cycle?
Transcervical embryo transfer is a procedure performed without anesthesia. A catheter containing the embryos is placed into the uterine cavity via the cervix. The entire procedure takes approximately 10 minutes. (This is the standard method.)

Why are you doing this study?
Success rates with advanced fertility treatments like IVF decline with increasing age, especially in women over 38. Although some studies have reported improved implantation and pregnancy rates with ZIFT compared with IVF, other analyses have shown no difference between the two techniques. However, no studies have examined the efficacy of ZIFT specifically for older patients.

Will my medical care be changed by enrolling in the study?
Apart from being assigned to either a ZIFT or routine IVF embryo transfer, your care will not be changed in any manner by being enrolled in the study. The type and amount of medications that you take to stimulate the ovaries will not be changed based on your decision to enter the study.

How can I find out if I qualify for the study?
Read the above stated inclusion and exclusion criteria. If you match all the stated categories for the inclusion criteria and don’t match any of the criteria that can exclude you from participating in the study, then most likely you can participate. However, you will need to make an appointment with one of the doctors to find out for sure. Feel free to contact the front office if you have a question about any of the inclusion or exclusion criteria and how they relate to you.

Is the cost of my treatment changed because I am enrolling in the study?
Participants will be required to pay for all costs of the first treatment cycle. To clarify, you will be responsible for the standard costs associated with an IVF cycle regardless of whether you will be receiving IVF or ZIFT. If pregnancy does not occur in the first cycle and you proceed to the second cycle of treatment, you will only be responsible for paying for non-USC related charges including fees for the surgi-center, labs and medications. All USC related costs will be waived, thereby reducing the cost of the second cycle to less than 1/2 of the standard cost of treatment.

How can I find out more information about the study?

The front office can assist you with some basic questions about the study, however if you really want to discuss it in detail we suggest you make an appointment with one of our doctors for a consultation.