Needle-Free Injections of Gonadotropins for Superovulation

NCT ID: NCT02106689

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-01-31

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Needle free system

Intervention will consist of the gonadotropin "BRAVELLE" being injected using the Comfort-in™ needle free system for the duration of a standard superovulation cycle

Group Type: EXPERIMENTAL

Needle free system

Intervention Type: DEVICE

Approximately 60 patients will be randomized in a 1:1 ratio to either receive their gonadotropin injections using the Comfort-in™ needle free system (treatment group), or through the standard needle and syringe (control group).

Standard needle injection system

Control patients will undergo their superovulation cycle using the gold standard subcutaneous needle injection system for their gonadotropin injections

Group Type: ACTIVE_COMPARATOR

Standard needle injection system

Intervention Type: DEVICE

Approximately 60 patients will be randomized in a 1:1 ratio to either receive their gonadotropin injections using the Comfort-in™ needle free system (treatment group), or through the standard needle and syringe (control group).

Interventions

Needle free system

Approximately 60 patients will be randomized in a 1:1 ratio to either receive their gonadotropin injections using the Comfort-in™ needle free system (treatment group), or through the standard needle and syringe (control group).

Intervention Type: DEVICE

Standard needle injection system

Approximately 60 patients will be randomized in a 1:1 ratio to either receive their gonadotropin injections using the Comfort-in™ needle free system (treatment group), or through the standard needle and syringe (control group).

Intervention Type: DEVICE

Other Intervention Names

Comfort-in™ needle free system

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pacific Centre for Reproductive Medicine

NETWORK

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Seethram

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Seethram, MD, FRCSC, FACOG

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Pacific Centre for Reproductive Medicine

Burnaby, British Columbia, Canada

Countries

Canada

Other Identifiers

H13-03229

Identifier Type: -

Identifier Source: org_study_id