| Title: |
Individualized versus standard FSH dosing in women starting IVF/ICSI:an RCT, Part 1: The predicted poor responder |
| Authors: |
Tilborg, Theodora C Van; Torrance, Helen L; Oudshoorn, Simone C; Eijkemans, Marinus JC; Koks, Carolien AM; Verhoeve, Harold R; Nap, Annemiek W; Scheffer, Gabrielle J; Petra Manger, A; Schoot, BC Benedictus; Sluijmer, Alexander V; Verhoeff, Arie; Groen, Henk; Laven, Joop SE; Mol, Ben WJ; Broekmans, Frank JM; Mochtar, Monique H; Golde, Ron JT Van; Hoek, Annemieke; Jur Oosterhuis, G E; Kuchenbecker, Walter KH; Fleischer, Kathrin; Bruin, Jan Peter De; Friederich, Jaap; Hooff, Marcel HA Van; Santbrink, Evert JP Van; Brinkhuis, Egbert A; Smeenk, Jesper MJ; Kwee, Janet; Koning, Corry H De; Wely, Madelon Van; Lambalk, Cornelis B |
| Source: |
ISSN:0268-1161. |
| Publisher Information: |
Oxford University Press |
| Publication Year: |
2017 |
| Collection: |
Eindhoven University of Technology (TU/e): Research Portal |
| Description: |
STUDY QUESTION: Does an increased FSH dose result in higher cumulative live birth rates in women with a predicted poor ovarian response, apparent from a low antral follicle count (AFC), scheduled for IVF or ICSI? SUMMARY ANSWER: In women with a predicted poor ovarian response (AFC < 11) undergoing IVF/ICSI, an increased FSH dose (225/ 450 IU/day) does not improve cumulative live birth rates as compared to a standard dose (150 IU/day). WHAT IS KNOWN ALREADY: In women scheduled for IVF/ICSI, an ovarian reserve test (ORT) can predict ovarian response to stimulation. The FSH starting dose is often adjusted based on the ORT from the belief that it will improve live birth rates. However, the existing RCTs on this topic, most of which show no benefit, are underpowered. STUDY DESIGN, SIZE, DURATION: Between May 2011 and May 2014, we performed an open-label multicentre RCT in women with an AFC < 11 (Dutch Trial Register NTR2657). The primary outcome was ongoing pregnancy achieved within 18 months after randomization and resulting in a live birth. We needed 300 women to assess whether an increased dose strategy would increase the cumulative live birth rate from 25 to 40% (two-sided alpha-error 0.05, power 80%). PARTICIPANTS/MATERIALS, SETTING, METHODS: Women with an AFC ≤ 7 were randomized to an FSH dose of 450 IU/day or 150 IU/day, and women with an AFC 8–10 were randomized to 225 IU or 150 IU/day. In the standard group, dose adjustment was allowed in subsequent cycles based on pre-specified criteria. Both effectiveness and cost-effectiveness of the strategies were evaluated from an intention-to-treat perspective. MAIN RESULTS AND THE ROLE OF CHANCE: In total, 511 women were randomized, 234 with an AFC ≤ 7 and 277 with an AFC 8–10. The cumulative live birth rate for increased versus standard dosing was 42.4% (106/250) versus 44.8% (117/261), respectively [relative risk (RR): 0.95 (95%CI, 0.78–1.15), P = 0.58]. As an increased dose strategy was more expensive [delta costs/woman: €1099 (95%CI, 562–1591)], standard ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
http://repository.tue.nl/900749 |
| Availability: |
http://repository.tue.nl/900749 |
| Rights: |
Copyright (c) Tilborg, Theodora C Van ; Copyright (c) Torrance, Helen L ; Copyright (c) Oudshoorn, Simone C ; Copyright (c) Eijkemans, Marinus JC ; Copyright (c) Koks, Carolien AM ; Copyright (c) Verhoeve, Harold R ; Copyright (c) Nap, Annemiek W ; Copyright (c) Scheffer, Gabrielle J ; Copyright (c) Petra Manger, A ; Copyright (c) Schoot, BC Benedictus ; Copyright (c) Sluijmer, Alexander V ; Copyright (c) Verhoeff, Arie ; Copyright (c) Groen, Henk ; Copyright (c) Laven, Joop SE ; Copyright (c) Mol, Ben WJ ; Copyright (c) Broekmans, Frank JM ; Copyright (c) Mochtar, Monique H ; Copyright (c) Golde, Ron JT Van ; Copyright (c) Hoek, Annemieke ; Copyright (c) Jur Oosterhuis, G E ; Copyright (c) Kuchenbecker, Walter KH ; Copyright (c) Fleischer, Kathrin ; Copyright (c) Bruin, Jan Peter De ; Copyright (c) Friederich, Jaap ; Copyright (c) Hooff, Marcel HA Van ; Copyright (c) Santbrink, Evert JP Van ; Copyright (c) Brinkhuis, Egbert A ; Copyright (c) Smeenk, Jesper MJ ; Copyright (c) Kwee, Janet ; Copyright (c) Koning, Corry H De ; Copyright (c) Wely, Madelon Van ; Copyright (c) Lambalk, Cornelis B |
| Accession Number: |
edsbas.525C1611 |
| Database: |
BASE |