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NCT03939390: SUBLUTEAL

Follicular Phase Stimulation vs. Luteal Phase Stimulation in Patients Diagnosed With Suboptimal Response

Completed Phase 4 Last updated 6 April 2022
What this trial tests

Phase 4 trial testing time of administration of Corifollitropin Alfa in Improving Ovarian Stimulation; Suboptimal Responders in 41 participants. Completed in 2 April 2022.

Timeline
17 January 2020
Primary endpoint
2 April 2022
2 April 2022

Quick facts

Lead sponsorInstituto Bernabeu
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment41
Start date17 January 2020
Primary completion2 April 2022
Estimated completion2 April 2022
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Instituto Bernabeu — full company profile →

Who can join

Adults 18 to 41, female only, with Improving Ovarian Stimulation; Suboptimal Responders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to investigate the difference in the number of oocytes obtained by performing ovarian stimulation in follicular phase vs. luteal phase in a population of patients with previous suboptimal response. This is a controlled randomized clinical study. We aim to include 41 patients diagnosed with suboptimal response who will undergo an ovarian stimulation in order to vitrify and accumulate oocytes. The main variable for evaluating the efficacy in this exploratory study will be the number of oocyte cumulus complexes obtained.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Conventional follicular-phase ovarian stimulation vs. luteal-phase stimulation in suboptimal responders: a randomized controlled trial.
    Suñol J, Castillo JC, Ortiz JA, Ten J, et al · · 2023 · cited 2× · PMID 38204945 · DOI 10.1016/j.xfre.2023.07.003

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