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

Completed · Not applicable

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT02865681

Run by

New Hope Fertility Center

People needed

4

Starts

2016-07-01

Expected to finish

2017-06-07

Last updated by the study team

2019-03-19

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• New Hope Fertility Center — New York, New York, United States

Full record on ClinicalTrials.gov

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