Infertility Clinical Trial
Official title:
Protocol to Minimize Injections and Blood Draws for Women Undergoing Controlled Ovarian Hyperstimulation for in Vitro Fertilization
NCT number | NCT02865681 |
Other study ID # | JZ08-15 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2016 |
Est. completion date | June 7, 2017 |
Verified date | March 2019 |
Source | New Hope Fertility Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4 |
Est. completion date | June 7, 2017 |
Est. primary completion date | June 7, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | New Hope Fertility Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New Hope Fertility Center |
United States,
Zhang J, Merhi Z. Safety data for the use of nasal human menopausal gonadotropins: a potential novel approach for fertility treatment. JBRA Assist Reprod. 2018 Nov 30. doi: 10.5935/1518-0557.20180078. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum estradiol level | serum estradiol level in pg/mL as representative of ovarian response | 1 year | |
Primary | Ovarian follicular size | Pelvic ultrasound to measure the size of each ovarian follicle as representative of ovarian response | 1 year | |
Secondary | Adverse Events That Are Related to Nasal Menopur Treatment | whether there are any side effects | 1 year |
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