Is analgesia required for transvaginal single-follicle aspiration in in vitro fertilization? A double-blind study

“…CSA was compared to placebo in one RCT, which showed a significantly higher intraoperative pain in the placebo group, confirming the value of pain relief during oocyte retrieval (Ramsewak et al, 1990).…”

Section: Interventions and Significant Resultsmentioning

confidence: 76%

Trends in research on pain relief during oocyte retrieval for IVF/ICSI: a systematic, methodological review

Buisman

Grens

Wang

et al. 2022

Human Reproduction Open

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STUDY QUESTION What is the methodological validity and usefulness of randomised controlled trials (RCTs) on pain relief during oocyte retrieval for IVF and ICSI? SUMMARY ANSWER Key methodological characteristics such as randomisation, allocation concealment, primary outcome measure, and sample size calculation were inadequately reported in 33 to 43% of the included RCTs, and a broad heterogeneity is revealed in the studied outcome measures. WHAT IS KNOWN ALREADY A Cochrane review on conscious sedation and analgesia (CSA) for women undergoing oocyte retrieval concluded that the overall quality of evidence was low or very low, mainly owing to poor reporting. This, and heterogeneity of studied outcome measures limits generalisability, and eligibility of results for meta-analysis. STUDY DESIGN, SIZE AND DURATION For this review, a systematic search for RCTs on pain relief during oocyte retrieval was performed on July 20th 2020 in CENTRAL CRSO, MEDLINE, Embase, PsycINFO, CINAHL, ClinicalTrials.gov, WHO ICTRP, Web of science, Portal Regional da BVS, and Open Grey. PARTICIPANTS/MATERIALS, SETTING, METHODS RCTs with pain or patient satisfaction as an outcome were included and analysed on a set of methodological and clinical characteristics, to determine their validity and usefulness. MAIN RESULTS AND THE ROLE OF CHANCE Screening of 2531 articles led to an inclusion of 51 RCTs. Randomisation was described inadequately in 33% of the RCTs. A low-risk method of allocation concealment was reported in 55% of the RCTs. Forty-nine percent of the RCTs reported blinding of participants, 33% of blinding personnel, and 43% of blinding the outcome assessor. In 63% of the RCTs, the primary outcome was stated, but a sample size calculation was described in only 57%. Data was analysed according to the intention-to-treat principle in 73%. Treatment groups were not treated identically other than the intervention of interest in 10% of the RCTs. The primary outcome was intraoperative pain in 28%, and postoperative pain in 2%. The visual analogue scale (VAS) was the most used pain scale, in 69% of the RCTs in which pain was measured. Overall, nine other scales were used. Patient satisfaction was measured in 49% of the RCTs, for which 12 different methods were used. Occurrence of side-effects and complications were assessed in 77% and 49% of the RCTs: a definition for these was lacking in 13% and 20% of the RCTs, respectively. Pregnancy rate was reported in 55% of the RCTs and, of these, 75% did not adequately define pregnancy. To improve the quality of future research, we provide recommendations for the design of future trials. These include use of the VAS for pain measurement, use of validated questionnaires for measurement of patient satisfaction, and the minimal clinically relevant difference to use for sample size calculations. LIMITATIONS, REASONS FOR CAUTION Consensus has not been reached on some methodological characteristics, for which we formulated recommendations. To prevent further heterogeneity in research on this topic, recommendations were formulated based on expert opinion, or on the most used method thus far. Future research may provide evidence to base new recommendations on. WIDER IMPLICATIONS OF THE FINDINGS Use of the recommendations given for design of trials on this topic can increase the generalisability of future research, increasing eligibility for meta-analyses, and preventing wastefulness. STUDY FUNDING/COMPETING INTEREST(S) No specific funding was obtained for this study. S.B. reports being the editor-in-chief of Human Reproduction Open. For this manuscript, he was not involved with the handling process within Human Reproduction Open, or with the final decision. Further, S.B. reports personal fees from Remuneration from Oxford University Press as editor-in-chief of Human Reproduction Open, personal fees from Editor and contributing author, Reproductive Medicine for the MRCOG, Cambridge University Press. The remaining authors declare no conflict of interest in relation to the work presented. TRIAL REGISTRATION NUMBER Not applicable.

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“…However, experience from natural N.A.Ahmed Ebbiary et at. (Ramsewak et al, 1990) and stimulated cycles of IVF (Feichtinger et al, 1988) suggests that trans vaginal oocyte recovery can be carried out without any analgesia. As the FC needle is much thinner and the procedure itself is less invasive than an oocyte retrieval procedure, narcotic analgesia was not offered routinely during the later part of the study and was well tolerated by most of the subjects.…”

Section: Discussionmentioning

confidence: 98%

Ovary and ovulation: Folliculocentesis: a novel research technique to investigate the intrafollicular endocrine microenvironment

et al. 1995

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During development of the dominant follicle, the avascular granulosa cells and oocyte are exposed to the follicular fluid endocrine microenvironment. An alteration in the endocrine characteristics of follicular fluid affects follicular steroidogenesis, oocyte maturation, ovulation and subsequent corpus luteum function. In-vitro studies on pooled follicular fluid from ovarian specimens lacked temporal precision between menstrual and follicular endocrine events. We have established a new technique, termed folliculocentesis (FC), to sample follicular fluid from the dominant ovarian follicle without compromising its growth or function during the mid- to late follicular phase. A total of 38 subjects with regular ovulatory cycles each underwent two identical cycles of hormone and follicle growth monitoring: one cycle served as the control, and FC was performed during the second cycle. During all cycles, plasma luteinizing hormone (LH), oestradiol and ultrasound monitoring of follicle growth were commenced on day 7 and continued until after ovulation. During FC cycles, 200 microliters of follicular fluid were aspirated from the dominant follicle using transvaginal ultrasound guidance when the follicle diameter reached > or = 10 mm. Six subjects were excluded from the study because of incomplete or invalid endocrine data. In all, 32 subjects completed both the FC and control cycles. The follicle growth pattern, maximum follicle diameter, plasma oestradiol, oestradiol peak, plasma LH, LH surge and follicular phase length were similar during FC and control cycles. A total of 50 valid follicular fluid samples were obtained when the dominant follicle was sampled once, twice or three times during the same cycle and from the same follicle in 15, 16 and one subjects respectively. The follicular fluid samples contained steroid concentrations consistent with those of the mid- to late follicular phase. We conclude that the FC procedure is safe, easy to perform and does not affect follicle growth or hormone dynamics. Analysis of the follicular fluid samples is expected to provide us with valuable in-vivo information about ovarian endocrinology.

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Is analgesia required for transvaginal single-follicle aspiration in in vitro fertilization? A double-blind study

Cited by 29 publications

References 11 publications

Analgesia and anesthesia for assisted reproductive technologies

Analgesia and anesthesia for assisted reproductive technologies

Trends in research on pain relief during oocyte retrieval for IVF/ICSI: a systematic, methodological review

Ovary and ovulation: Folliculocentesis: a novel research technique to investigate the intrafollicular endocrine microenvironment

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