Infertility Clinical Trial
Official title:
Optimizing Patient Analgesic Experience During IVF
NCT number | NCT01814657 |
Other study ID # | 00029750 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | November 7, 2015 |
Verified date | December 2014 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is for patients undergoing In Vitro Fertilization (IVF). The investigators are studying the best way to control pain during the egg retrieval process. The egg retrieval involves passing a needle under ultrasound guidance through the vagina into the ovaries to remove eggs that are to be later fertilized. Patients often report this as very uncomfortable. Different fertility clinics across the country use different methods of pain control. All clinics will use intravenous medication to control pain, while some may or may not use local anaesthetic (freezing) in the vagina. Our goal is to find the best way to control pain. Since local anaesthetic injection involves multiple needle punctures and may be painful, the investigators are unsure if local anaesthetic is necessary in addition to the intravenous pain medication. The investigators will conduct a randomized trial where all patients will receive intravenous pain medication, but some will receive local anaesthetic injection and some will receive placebo injection. Patients will be asked to complete a questionnaire on their pain experience after oocyte retrieval. The investigators will then analyze the data and determine whether local anaesthetic actually improves pain when patients are already receiving intravenous pain medications. Through our study, the investigators aim to improve the pain experience of all women undergoing IVF in the future.
Status | Completed |
Enrollment | 308 |
Est. completion date | November 7, 2015 |
Est. primary completion date | November 7, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 43 Years |
Eligibility | Inclusion Criteria: - Women undergoing oocyte retrieval who have consented to participation - Only the first ART cycle will be included Exclusion Criteria: - History of drug sensitivity to local anaesthetic agents - Women with any chronic pain syndrome |
Country | Name | City | State |
---|---|---|---|
Canada | Fertility and Womens Endocrine Clinic | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Live Birth Rates | Recorded as the number of infants born alive to the patient that resulted from embryos transferred during this study. | Within 12 months of oocyte retrieval | |
Primary | Pain scores rated on SF-MPQ | Score rating will be done before the patient is discharged following oocyte retrieval. | Data collection is scheduled to proceed until 308 participants have been recruited which is anticipated to take up to 2 years. | |
Secondary | Embryology data | Recorded as number of embryos obtained. Number of embryos transferred. The decision to transfer Day 3 embryos or Day 5 blastocysts. Number of embryos or blastocysts frozen. Embryological grading of all embryos or blastocysts either transferred or frozen. | Assessed within 7 days of oocyte retrieval |
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