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RECRUITING
NCT04983173
PHASE4

INTEnsity of ovariaN Stimulation and Embryo Quality

Sponsor: Fundación Santiago Dexeus Font

View on ClinicalTrials.gov

Summary

The management of suboptimal ovarian responders remains a challenging task in IVF. These patients are frequently managed with an intense stimulation protocol of ovarian stimulation in order obtain the maximum number of embryos and, therefore, maximize the cumulative live birth rate. However, the concept of "the more the better" has been recently defied by the one of "mild stimulation". Defenders of this protocol state that with mild stimulation only the best quality oocytes are allowed to grow and, therefore, higher quality embryos will be obtained. However, the impact of the intensity of ovarian stimulation on embryo quality is far from consensual. Moreover, its effect on early embryo development has never been evaluated. Therefore, the investigators set out to perform this randomized controlled trial comparing the number of GQB and the morphokinetic parameters of early embryo development in infertile patients undergoing two different intensities of ovarian stimulation, a milder approach (CC plus 150 IU daily dose of rFSH) and a more intense approach (300 IU daily dose of rFSH).

Official title: The Impact of the Intensity of Ovarian Stimulation on Embryo Quality in Predicted Suboptimal Responders. A Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

35 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2021-11-23

Completion Date

2026-06

Last Updated

2026-03-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Ovarian Stimulation with CC+rFSH

: CC 50 mg/day (Omifin®) + rFSH 150 IU (Ovaleap®) GnRH antagonist: ganirelix 0.25 mg (Orgalutran®) Recombinant human chorionic gonadotropin (rhCG) 250 μg (Ovitrelle®) micronized progesterone 200 mg 3id (Utrogestan®)

DRUG

Ovarian Stimulation with rFSH

rFSH 300 IU rFSH (Ovaleap®) GnRH antagonist: ganirelix 0.25 mg (Orgalutran®) Recombinant human chorionic gonadotropin (rhCG) 250 μg (Ovitrelle®) micronized progesterone 200 mg 3id (Utrogestan®)

Locations (1)

Salud de la Mujer Dexeus

Barcelona, Spain