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A Non-inferiority Trial on Pain Relief During Oocyte Retrieval

Information source: Kwong Wah Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: fentanyl (Drug); pethidine (Drug); Diazepam (Drug); Midazolam (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Kwong Wah Hospital

Official(s) and/or principal investigator(s):
Shui Fan Lai, Principal Investigator, Affiliation: Kwong Wah Hospital

Overall contact:
Shui Fan Lai, MBBS, Phone: 85235172274, Email: lsf087@ha.org.hk

Summary

The objective of the trial is to compare fentanyl and midazolam vs diazepam and pethidine in terms of the pain levels and post-operative side effects of TUGOR

Clinical Details

Official title: A Prospective, Non-inferiority Randomized Double-blinded Trial Comparing Fentanyl and Midazolam vs Diazepam and Pethidine for Pain Relief During Oocyte Retrieval

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Primary outcome:

pain level during oocyte retrieval

pain level after oocyte retrieval

Secondary outcome:

side effects from medications

satisfaction

clinical pregnancy rate

ongoing pregnancy rate

Detailed description: In-vitro fertilization / embryo transfer (IVF / ET) is a well-established method to treat various causes of infertility. It involves multiple follicular development, retrieval of oocytes and embryo transfer after fertilization. Egg retrieval at the majority of IVF units is performed through the transvaginal route under ultrasound guidance (TUGOR) [1]. During TUGOR, the needle has to pass through the mucosa in the vaginal vault in order to puncture the follicles in the ovary. The procedures are generally short, lasting about 20-30 minutes but are still painful without anaesthesia or analgesia. Intravenous sedation with or without local anaesthesia is the most widely used method. Conscious sedation is a safe and cost-effective method of providing analgesia and anesthesia for TUGOR. [2] It is easy to administer in cooperative and motivated patients. It has a relatively low risk for adverse effects on oocyte and embryo quality and pregnancy rates. [3] Paracervical block (PCB) in conjunction with conscious sedation during TUGOR was shown to significantly reduce the pain during TUGOR when compared to PCB alone [4]. A Cochrane review on various methods of sedation and analgesia for pain relief during TUGOR has shown no single method or delivery system appeared superior for pregnancy rates and pain relief. [5] Most of the methods seemed to work well and the effect was usually enhanced by addition of another method such as pain relief with paracervical block. [6] The investigators' reproductive centre has recently aligned with the Assisted Reproduction Centre of the University of Hong Kong (HKU). The investigators are using 0. 1mg fentanyl and 5mg midazolam intravenously for pain relief in TUGOR at Kwong Wah Hospital (KWH) whereas 5mg diazepam and 25mg pethidine intravenously are being used in HKU. The investigators would like to compare fentanyl and midazolam vs diazepam and pethidine in terms of pain levels and post-operative side effects of TUGOR in this prospective non-inferiority randomized double-blinded trial. The investigators postulate there are no differences in the pain levels between two groups but the postoperative side effects may be different.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- presence of both ovaries;

- body mass index less than 30

- written informed consent and

- Chinese

Exclusion Criteria:

- IVF cycle converted from ovulation induction or intrauterine insemination cycles;

- patient requests general anaesthesia for TUGOR;

- history of drug sensitivity to lignocaine/fentanyl/midazolam/diazepam/pethidine;

- less than 3 dominant follicles present;

- dominant follicles present in one ovary only and

- TUGOR performed on one side only.

Locations and Contacts

Shui Fan Lai, MBBS, Phone: 85235172274, Email: lsf087@ha.org.hk

Additional Information

Starting date: July 2015
Last updated: July 20, 2015

Page last updated: August 23, 2015

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