Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization
Infertility
About this trial
This is an interventional other trial for Infertility focused on measuring Infertility, Gonadotropins, Menopur, Ovarian stimulation
Eligibility Criteria
Inclusion Criteria:
- Age range: 18-45. The participant should be a woman of reproductive age, i.e., premenopausal who is healthy.
- Body mass index: 19-35 kg/m2
- Diagnosis of infertility: inability to conceive with unprotected intercourse after 1 year for women aged < 35 and after 6 months for women aged > 35.
- Pap smear within 1 year should be normal.
- Endometrial cavity will be evaluated and should be normal using hysteroscopy or saline ultrasound
- 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.
- Semen analysis will be performed on every male partner to ensure that there are sperm to be used for IVF/ICSI.
- All assessment will be performed at baseline and before initiation of any treatment.
- 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:
- Any medical condition that interferes with the health of the participant such as uncontrolled diabetes, uncontrolled hypertension, cardiac disease, or renal disease.
- Any type of malignancy.
- Mental problems that could interfere with the patient's ability to conceive and take care of her baby.
- Abnormal endometrial cavity that could interfere with implantation and/or carrying the pregnancy.
Sites / Locations
- New Hope Fertility Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Conventional IVF
IVF protocol using nasal gonadotropins
Conventional ovarian stimulation consist of ovarian stimulation with daily gonadotropins injections daily starting in the early follicular phase (cycle day 3). The final maturation of oocytes will be induced with the standard hCG trigger when at least two follicles reached 18 mm or greater. Oocyte retrieval will be performed by either local or general anesthesia depending on the ovarian response, i.e., the number of mature follicles. Retrieved oocytes will be fertilized by IVF/ICSI and subsequently cultured until the blastocyst stage. All blastocysts will be vitrified. A single thawed blastocyst will be transferred in a subsequent natural or artificially prepared cycle.
Instead of injectable gonadotropins, nasal human menopausal gonadotropins (hMG; menopur) and oral clomiphene citrate and/or oral letrozole starting in the early follicular phase (cycle day 3). When at least two follicles reached 18 mm or greater, Synarel (Nafarelin) will be used instead of the injectable HCG trigger. Oocyte retrieval will be performed by either local or general anesthesia depending on the ovarian response, i.e., the number of mature follicles. Retrieved oocytes will be fertilized by IVF/ICSI and subsequently cultured until the blastocyst stage. All blastocysts will be vitrified. A single thawed blastocyst will be transferred in a subsequent natural or artificially prepared cycle.