Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 14, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2017
CompletedMarch 19, 2019
March 1, 2019
11 months
July 14, 2016
March 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Serum estradiol level
serum estradiol level in pg/mL as representative of ovarian response
1 year
Ovarian follicular size
Pelvic ultrasound to measure the size of each ovarian follicle as representative of ovarian response
1 year
Secondary Outcomes (1)
Adverse Events That Are Related to Nasal Menopur Treatment
1 year
Study Arms (2)
Conventional IVF
ACTIVE COMPARATORConventional 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.
IVF protocol using nasal gonadotropins
EXPERIMENTALInstead 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.
Interventions
Nasal versus injectable
oral
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New Hope Fertility Center
New York, New York, 10019, United States
Related Publications (1)
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.
PMID: 30500132RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Assistant Professor
Study Record Dates
First Submitted
July 14, 2016
First Posted
August 12, 2016
Study Start
July 1, 2016
Primary Completion
June 7, 2017
Study Completion
June 7, 2017
Last Updated
March 19, 2019
Record last verified: 2019-03