Clinical trial NCT02106689: Needle-Free Injections of Gonadotropins for Superovulation
Official title: Needle Free Injections of Gonadotropins for Patients Undergoing Superovulation - A Randomized, Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: infertility, superovulation, gonadotropins, needle free injection system
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Pacific Centre for Reproductive Medicine
First posted: 2014-04-08
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The daily injections required for superovulation, a fertility treatment using injections to stimulate a women's ovaries to produce multiple eggs, can be an anxiety provoking process for many women and a deterrent to treatment. Alternative needle-free injection systems have been developed with the intention of reducing needle phobia and pain, while providing similar results. However, these needle-free systems are not yet being widely used for women with infertility.

The purpose of this study is to assess whether the pain and apprehension patients often associate with needles and injections, can be alleviated by using a new, Health Canada approved, needle-free system. The purpose of the current study is to assess whether patient satisfaction is improved in patients using a needle free injection system for the daily self injections required for superovulation induction as compared to patients using the standard needle and syringe.

Detailed description: Injectable medications called gonadotropins are often necessary for fertility treatments. Superovulation is the process of using injections to stimulate a woman's ovary to produce multiple eggs. Having multiple eggs mature increases women's chances that at least 1 egg is fertilized.

The daily injections required for superovulation, can be an anxiety provoking process for many women and a deterrent to treatment. Alternative needle-free injection systems have been developed with the intention of reducing needle phobia and pain, while providing similar results. However, these needle-free systems are not yet being widely used for women with infertility.

The purpose of this study is to assess whether the pain and apprehension patients often associate with needles and injections, can be alleviated by using a new, Health Canada approved, needle-free system. Studies have shown that needle-free injection systems are just as effective as standard self injections when used for the delivery of medications subcutaneously (i.e., delivered just beneath the skin) - such as insulin, vaccinations and local anesthetic.

To date, there have been two studies that have examined the use of needle-free injections specifically for in vitro fertilization. The results of these studies showed that the needle-free system was as successful as standard injections in promoting ovarian stimulation and achieving pregnancies. However, what has not yet been demonstrated is whether patients think that the needle-free system is easier is use and less painful to administer than the standard injections. The purpose of the current study is to assess whether patient satisfaction is improved in patients using a needle free injection system for the daily self injections required for superovulation induction as compared to patients using the standard needle and syringe.

Eligibility criteria: Inclusion Criteria:

* Women undergoing their first cycle of superovulation
* Age 18-39
* BMI 18-35 kg/m2
* Uterine cavity evaluation (hysterosalpingogram, sonohysterogram, hysteroscopy) normal in the preceding 6 or 12 months
* Early follicular phase (Day 2 or Day 3) serum FSH \<12 IU/L in the preceding 12 months
* Subject able to give informed consent
* At least 1 patent fallopian tube
* One semen analysis in the prior 12 months with total motile count \> 10M

Exclusion Criteria:

* Prior enrollment in this study
* Any prior early follicular phase serum FSH level ≥12 IU/L
* Previous ovarian stimulation with gonadotropins
* Diabetes mellitus or uncontrolled thyroid disease
* Abnormal uterine cavity, such as unresected submucosal fibroids, uterine septum, Mullerian anomaly such as bicornuate or unicornuate uterus or intrauterine adhesions
* Hydrosalpinx

Primary outcomes:
measure: Change in Patient satisfaction
timeFrame: Change in rating of patient satisfaction from the day of enrollment to 10 days after self-injections are initiated
Secondary outcomes:
measure: Serum levels of Luteinizing Hormone and Follicle Stimulating Hormone
timeFrame: measured on cycle days 3, 6, 8 and on the day the human chorionic gonadotropin injection is administered (given within 24 hours when at least one follicle greater than 18 millimeters is seen)
measure: Peak estradiol level
timeFrame: measured on the day the human chorionic gonadotropin injection is administered (given within 24 hours when at least one follicle greater than 18 millimeters is seen)
measure: Number of days of stimulation
timeFrame: measured at the end of the superovulation cycle (an average of 8 to 10 days after daily injections are initiated)
measure: Total gonadotropin dose
timeFrame: measured at the end of the superovulation cycle (an average of 8 to 10 days after daily injections are initiated).
measure: Number of follicles greater than 14 millimeters
timeFrame: Measured at the end of the superovulation cycle (an average of 8 to 10 days after daily injections are initiated).
measure: Clinical pregnancy rate
timeFrame: measured two weeks after embryo transfer
measure: Ease of use of the injection system
timeFrame: measured on the day the human chorionic gonadotropin injection is administered (given within 24 hours when at least one follicle greater than 18 millimeters is seen)
measure: Self confidence in the use of the injection system
timeFrame: measured on the day the human chorionic gonadotropin injection is administered (given within 24 hours when at least one follicle greater than 18 millimeters is seen)
measure: Self image
timeFrame: measured on the day the human chorionic gonadotropin injection is administered (given within 24 hours when at least one follicle greater than 18 millimeters is seen)
measure: Injection site reaction
timeFrame: measured on the day the human chorionic gonadotropin injection is administered (given within 24 hours when at least one follicle greater than 18 millimeters is seen)
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Pacific Centre for Reproductive Medicine
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kenneth Seethram, MD, FRCSC, FACOG
role: PRINCIPAL_INVESTIGATOR
References: