Needle-Free Injections of Gonadotropins for Superovulation

NCT02106689 | Terminated

• 1 other identifier: H13-03229
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

infertility, superovulation, gonadotropins, needle free injection system

Outcome Measures

Primary Outcomes (1)

• Change in Patient satisfaction

  To assess change in self-rated patient satisfaction with the Comfort-in™ needle free injection system as compared to the standard subcutaneous needle injection. This will be determined by the Self-Injection Assessment Questionnaire, which incorporates a pre-injection assessment of needle apprehension, as well as post-injection assessment of patient experience.

  Change in rating of patient satisfaction from the day of enrollment to 10 days after self-injections are initiated

Secondary Outcomes (10)

• Serum levels of Luteinizing Hormone and Follicle Stimulating Hormone

  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)

• Peak estradiol level

  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)

• Number of days of stimulation

  measured at the end of the superovulation cycle (an average of 8 to 10 days after daily injections are initiated)

• Total gonadotropin dose

  measured at the end of the superovulation cycle (an average of 8 to 10 days after daily injections are initiated).

• Number of follicles greater than 14 millimeters

  Measured at the end of the superovulation cycle (an average of 8 to 10 days after daily injections are initiated).

Study Arms (2)

Needle free system

EXPERIMENTAL

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

Device: Needle free system

Standard needle injection system

ACTIVE COMPARATOR

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

Device: Standard needle injection system

Interventions

Needle free system 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).

Also known as: Comfort-in™ needle free system

Needle free system

Standard needle injection system 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

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Pacific Centre for Reproductive Medicine: collaborator

Study Sites (1)

Pacific Centre for Reproductive Medicine

Burnaby, British Columbia, V5G 4X7, Canada

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Kenneth Seethram, MD, FRCSC, FACOG

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: April 8, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

CA (1)