Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization

Gonadotropins are used during fertility treatments such as intrauterine insemination (IUI) or
in vitro fertilization (IVF). These fertility medications are given by injection that contain
follicle-stimulating hormone (FSH) alone or combined with luteinizing hormone (LH). During a
regularly occurring menstrual cycle, both FSH and LH are produced by the pituitary gland in
the brain to naturally stimulate the ovaries to make a single egg each month. When FSH and/or
LH are given as an injection as fertility treatment, they work directly on the ovaries to
make multiple follicles which are cysts containing the eggs.

Injections of gonadotropins are started early (usually on the third day) in the menstrual
cycle to cause multiple eggs to grow to a mature size. Close monitoring of patients with
ultrasound and blood are usually needed for monitoring. The ultrasound measures the size of
the ovarian follicles. Blood is usually drawn every other day or daily (for a total of 12
days on average) for measurement of Estradiol (E2), progesterone (P4), and luteinizing
hormone (LH). The measurement of E2, P4 and LH is intended to quantify the response of the
ovaries to the daily injectable gonadotropins. When the follicles grow to a large size
(usually 18 mm), human chorionic gonadotropin (hCG), another injectable medication, is then
used to trigger the maturity of the eggs before performing egg retrieval during an IVF cycle.

Instead of injectable gonadotropins, this study uses nasal gonadotropins (Menopur) in order
to evaluate its safety and efficacy of in women undergoing IVF.

Inclusion Criteria:

1. Age range: 18-45. The participant should be a woman of reproductive age, i.e.,
premenopausal who is healthy.

2. Body mass index: 19-35 kg/m2

3. Diagnosis of infertility: inability to conceive with unprotected intercourse after 1
year for women aged < 35 and after 6 months for women aged > 35.

4. Pap smear within 1 year should be normal.

5. Endometrial cavity will be evaluated and should be normal using hysteroscopy or saline
ultrasound

6. Fallopian tubes will be assessed by hysterosalpingogram in women who have normal
ovarian reserve, regular menstrual cycles with a partner who has normal semen
analysis. Unless there is a clear diagnosis of a reason for infertility, such as poor
sperm, poor ovarian reserve, fallopian tube patency will not be performed because it
would not change the treatment.

7. Semen analysis will be performed on every male partner to ensure that there are sperm
to be used for IVF/ICSI.

8. All assessment will be performed at baseline and before initiation of any treatment.

9. The investigators will obtain at screening Pap smear, hysteroscopy or saline
ultrasound, hysterosalpingography, and semen analysis if they have not been done
within one year of baseline.

Exclusion Criteria:

1. Any medical condition that interferes with the health of the participant such as
uncontrolled diabetes, uncontrolled hypertension, cardiac disease, or renal disease.

2. Any type of malignancy.

3. Mental problems that could interfere with the patient's ability to conceive and take
care of her baby.

4. Abnormal endometrial cavity that could interfere with implantation and/or carrying the
pregnancy.