Individualized versus standard FSH dosing in women starting IVF/ICSI: an RCT. Part 2: The predicted hyper responder

Oudshoorn, Simone C; Tilborg, Theodora C van; Eijkemans, Marinus J.C.; Oosterhuis, G. J. E.; Friederich, Jaap; Hooff, M.H.A. van; Brinkhuis, Egbert A.; Smeenk, J.M.J.; Kwee, Janet; Koning, Corry H de; Groen, Henk; Lambalk, Cornelis B.; Mol, Ben Willem J.; Broekmans, Frank J.; Torrance, Helen L.; Mochtar, Monique H.; Koks, Carolien A.M.; Golde, Ron J T van; Verhoeve, Harold R.; Nap, Annemiek W.; Scheffer, G.J.; Manger, A Petra; Hoek, Annemieke; Schoot, Bendictus C; Kuchenbecker, Walter K. H.; Fleischer, Kathrin; Bruin, Jan Peter de; Sluijmer, Alexander V.; Verhoeff, Arie; Santbrink, Evert J. P. van; Wely, Madelon van; Laven, Joop S.E.

doi:10.1093/humrep/dex319

Cited by 78 publications

(53 citation statements)

References 29 publications

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“…For predicted hyper responders, several trials-including the OPTIMIST trial-indicated that an individualized FSH dose has no negative impact on LBR although it potentially reduces OHSS risks. 18,26,29 The results of the current analyses, however, suggest that those findings might not be generalizable to all women with a predicted hyper response. Reducing the FSH dose from 150 to 100 IU/d decreases OHSS risks for the majority of the predicted hyper responders.…”

Section: Clinical and Research Implicationscontrasting

confidence: 75%

“…A total of 234 predicted poor, 277 predicted suboptimal and 521 predicted hyper responders were randomly allocated to a standard FSH dose (150 IU/d) or an individualized dose (450, 225 or 100 IU/d, respectively) (Figure ). Table summarizes the baseline characteristics and first cycle outcomes . In the predicted poor and suboptimal responders, female age and body weight did not modify the effect of FSH dose individualization on the four pre‐specified outcomes (see Supporting Information, Table S1).…”

Section: Resultsmentioning

confidence: 98%

“…Data of the OPTIMIST trial were used for secondary analysis. The background, methods and results of this trial have been published previously . The OPTIMIST study was registered at the ICMJE‐recognized Dutch Trial Registry (http://www.trialregister.nl); Registration number: NTR2657.…”

Section: Methodsmentioning

confidence: 99%

“…Table 1 summarizes the baseline characteristics and first cycle outcomes. 17,18 In the predicted poor and suboptimal responders, female age and body weight did not modify the effect of FSH dose individualization on the four pre-specified outcomes (see Supporting Information, Table S1).…”

Section: Re Sultsmentioning

confidence: 95%

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Do female age and body weight modify the effect of individualized FSH dosing in IVF/ICSI treatment? A secondary analysis of the OPTIMIST trial

Leijdekkers

Tilborg

Torrance

et al. 2019

Acta Obstet Gynecol Scand

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Introduction The OPTIMIST trial revealed that for women starting in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) treatment, no substantial differences exist in first cycle and cumulative live birth rates between an antral follicle count (AFC)‐based individualized follicle‐stimulating hormone (FSH) dose and a standard dose. Female age and body weight have been suggested to cause heterogeneity in the effect of FSH dose individualization. The objective of the current study is to evaluate whether these patient characteristics modify the effect of AFC‐based individualized FSH dosing in IVF/ICSI treatment. Material and methods A secondary data‐analysis of the OPTIMIST trial. Women initiating IVF/ICSI treatment were classified as predicted poor (AFC 0‐7), suboptimal (AFC 8‐10) or hyper responders (AFC >15), and randomly allocated to a standard FSH dose (150 IU/d) or an individualized FSH dose (450, 225 or 100 IU/d for predicted poor, suboptimal and hyper responders, respectively). In each predicted response category, logistic regression models with interaction terms were used to evaluate the presence of effect modification. The first cycle was analyzed, and the primary outcomes were first complete cycle live birth rate (including fresh plus frozen‐thawed embryo transfers) and ovarian hyperstimulation syndrome (OHSS) risks. Results No effect modification was revealed in the predicted poor (n = 234) and suboptimal (n = 277) responders. In the predicted hyper responders (n = 521), the effect of the individualized FSH dose on the first cycle live birth rate was modified by female age (P = 0.02) and the effect on OHSS risks was modified by body weight (P = 0.02). A dose reduction from 150 to 100 IU/d generally decreased the OHSS risks in predicted hyper responders, but also reduced the chance of a live birth in young women, and had no beneficial impact on OHSS risks in women with a relatively low body weight. Conclusions In women with a predicted hyper response undergoing IVF/ICSI treatment, female age and body weight seem to modify the effect of FSH dose individualization. Although a reduced FSH starting dose generally decreases the OHSS risks, it may also reduce the chance of a live birth, specifically for young women. Future studies could consider these findings when investigating the optimal approach to reduce OHSS risks while maintaining the probability of a live birth for predicted hyper responders in IVF/ICSI treatment.

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Section: Clinical and Research Implicationscontrasting

confidence: 75%

Section: Resultsmentioning

confidence: 98%

Section: Methodsmentioning

confidence: 99%

Section: Re Sultsmentioning

confidence: 95%

See 2 more Smart Citations

Do female age and body weight modify the effect of individualized FSH dosing in IVF/ICSI treatment? A secondary analysis of the OPTIMIST trial

Leijdekkers

Tilborg

Torrance

et al. 2019

Acta Obstet Gynecol Scand

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“…COS compensates for inefficiencies in the following stages of the cycle such as oocyte maturation and insemination, embryo culture and transfer, and implantation (Fauser et al 1999). Even though the basis of COS involves the administration of gonadotropins (Macklon et al 2006), it is now very clear that a 'one-size-fits-all' approach does not exist and an individualized treatment approach can cater to a patient's unique characteristics and maximizes success, eliminates iatrogenic risks and minimizes the risk of cycle cancellation (Scott et al 2013a,b, La Marca & Sunkara 2014, Oudshoorn et al 2017, van Tilborg et al 2017a. On the other hand, PGT describes the procedure of removing one or more nuclei from embryos, blastomeres or trophectoderm cells, to test for mutations in gene sequence or aneuploidy before transfer selection (Practice Committee of Society for Assisted Reproductive Technology & Practice Committee of American Society for Reproductive Medicine (2008)).…”

Section: How Many Oocytes Do We Need?mentioning

confidence: 99%

Ovarian stimulation for preimplantation genetic testing

Rodriguez-Purata

Martínez

2019

Reproduction

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A narrative review of the management of controlled ovarian stimulation in patients undergoing preimplantation genetic testing is presented. An electronic search was performed to identify research publications that addressed ovarian stimulation and preimplantation genetic testing published until December 2017. Studies were classified in decreasing categories: randomized controlled trials, prospective controlled trials, prospective non-controlled trials, retrospective studies and experimental studies. The aim of controlled ovarian stimulation has shifted from obtaining embryos available for transfer to yielding the maximum embryos available for biopsy to increase the odds of achieving one euploid embryo available for transfer, without the distress of inducing ovarian hyperstimulation syndrome or inadequate endometrium receptivity as vitrification and deferred embryo transfer usually will be planned. The present narrative review summarizes all treatment-related variables as well as stimulation strategies after controlled ovarian stimulation that could help patients undergoing an in vitro fertilization cycle coupled with preimplantation genetic testing, including the number of oocytes needed to achieve one healthy live birth, oral contraceptive pill usage, the role of mild ovarian stimulation or random-start stimulation, the stimulation protocol and type of gonadotropin of choice, the novel progesterone protocols, agonist or dual trigger as a final oocyte maturation trigger, the accumulation of oocytes/embryos and the optimal interval before proceeding with a subsequent controlled ovarian stimulation or the optimal medication to link stimulation cycles. The discussion is being presented according to how questions are posed in clinical practice. The aim of ovarian stimulation has shifted from obtaining embryos available for transfer to yielding the maximum embryos available for biopsy to increase the odds of achieving one euploid embryo available for transfer.

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Individualised gonadotropin dose selection using markers of ovarian reserve for women undergoing in vitro fertilisation plus intracytoplasmic sperm injection (IVF/ICSI)

Lensen

Wilkinson

Leijdekkers

et al. 2018

Cochrane Database of Systematic Reviews

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120

122

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We did not find that tailoring the FSH dose in any particular ORT population (low, normal, high ORT), influenced rates of live birth/ongoing pregnancy but we could not rule out differences, due to sample size limitations. In predicted high responders, lower doses of FSH seemed to reduce the overall incidence of moderate and severe OHSS. Moderate-quality evidence suggests that ORT-based individualisation produces similar live birth/ongoing pregnancy rates to a policy of giving all women 150 IU. However, in all cases the confidence intervals are consistent with an increase or decrease in the rate of around five percentage points with ORT-based dosing (e.g. from 25% to 20% or 30%). Although small, a difference of this magnitude could be important to many women. Further, ORT algorithms reduced the incidence of OHSS compared to standard dosing of 150 IU, probably by facilitating dose reductions in women with a predicted high response. However, the size of the effect is unclear. The included studies were heterogeneous in design, which limited the interpretation of pooled estimates, and many of the included studies had a serious risk of bias.Current evidence does not provide a clear justification for adjusting the standard dose of 150 IU in the case of poor or normal responders, especially as increased dose is generally associated with greater total FSH dose and therefore greater cost. However, a decreased dose in predicted high responders may reduce OHSS.

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Individualized versus standard FSH dosing in women starting IVF/ICSI: an RCT. Part 2: The predicted hyper responder

Abstract: 12 May 2011.

Cited by 78 publications

References 29 publications

Do female age and body weight modify the effect of individualized FSH dosing in IVF/ICSI treatment? A secondary analysis of the OPTIMIST trial

Do female age and body weight modify the effect of individualized FSH dosing in IVF/ICSI treatment? A secondary analysis of the OPTIMIST trial

Ovarian stimulation for preimplantation genetic testing

Individualised gonadotropin dose selection using markers of ovarian reserve for women undergoing in vitro fertilisation plus intracytoplasmic sperm injection (IVF/ICSI)

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