Clinical trial NCT02865681: Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization
Official title: Protocol to Minimize Injections and Blood Draws for Women Undergoing Controlled Ovarian Hyperstimulation for in Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Infertility
Gonadotropins
Menopur
Ovarian stimulation
Lead sponsor: New Hope Fertility Center
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to evaluate the safety and efficacy of nasal gonadotropins (Menopur) in women undergoing IVF. The purpose of this study is also to report and monitor any and all side effects of the nasal Menopur.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum estradiol level
timeFrame: 1 year
measure: Ovarian follicular size
timeFrame: 1 year
Secondary outcomes:
measure: Adverse Events That Are Related to Nasal Menopur Treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: New Hope Fertility Center
state: New York
Study officials:
References:
citation: Zhang J, Merhi Z. Safety data for the use of nasal human menopausal gonadotropins: a potential novel approach for fertility treatment. JBRA Assist Reprod. 2019 Apr 30;23(2):169-171. doi: 10.5935/1518-0557.20180078.