EUCTR2021-000941-42-ES
Active, not recruiting
Phase 1
The impact of the intensity of ovarian stimulation on embryo quality in predicted suboptimal responders. A randomized controlled trial. - INTENS-EQ_trial
Fundacion Santiago Dexeus Font0 sites100 target enrollmentJune 11, 2021
ConditionsTo compare the number of GQB and the morphokinetic parameters of early embryo development in infertile suboptimal patients undergoing two different intensities of ovarian stimulation, a milder approach ( Clomiphene Citrate (CC) 50mg/day plus 150IU daily dose of rFSH) and a more intense approach (300IU daily dose of rFSH).MedDRA version: 20.0Level: PTClassification code 10021928Term: Infertility femaleSystem Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 21.0Level: PTClassification code 10021926Term: InfertilitySystem Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 20.0Level: LLTClassification code 10021930Term: Infertility NOSSystem Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 20.0Level: PTClassification code 10021929Term: Infertility maleSystem Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 20.1Level: LLTClassification code 10016399Term: Female infertility (primary)System Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 21.1Level: LLTClassification code 10039843Term: Secondary infertility (female)System Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsOvaleap 900 UI/1,5 ml solucion inyectableOvaleap 450 UI/0,75 ml solucion inyectableOvaleap 300 UI/0,5 ml solucion inyectableOrgalutran 0,25 mg/0,5 ml solución inyectableOvitrelle 250 microgramos solución inyectable en pluma precargada.Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectableutrogestan 200 mg cápsulas blandasOmifin 50 mg comprimidos
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- To compare the number of GQB and the morphokinetic parameters of early embryo development in infertile suboptimal patients undergoing two different intensities of ovarian stimulation, a milder approach ( Clomiphene Citrate (CC) 50mg/day plus 150IU daily dose of rFSH) and a more intense approach (300IU daily dose of rFSH).
- Sponsor
- Fundacion Santiago Dexeus Font
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •AFC \= 5 and \= 10
- •AMH \=1\.5 ng/ml (AMH result of up to one year will be valid)
- •Age \= 35 years and \=40 years
- •BMI \>\=18\.5 and \<25 kg/m2
- •Willing to participate in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 100
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •History of untreated autoimmune, endocrine or metabolic disorders
- •Contraindication for hormonal treatment
- •Preimplantation genetic diagnosis
- •Severe male factor (sperm concentration \<5M/mL)
- •Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment and patients with any contraindication of being pregnant).
Outcomes
Primary Outcomes
Not specified
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