INTEnsity of ovariaN Stimulation and Embryo Quality

The impact of the intensity of ovarian stimulation on embryo quality in predicted suboptimal responders. A randomized controlled trial. - INTENS-EQ_trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000941-42-ES

Enrollment

100

Registered

2021-06-11

Start date

2021-07-06

Completion date

Unknown

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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). MedDRA version: 20.0 Level: PT Classification code 10021928 Term: Infertility female System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 2

Interventions

Trade Name: Ovaleap 900 UI/1,5 ml solucion inyectable Pharmaceutical Form: Solution for injection in pre-filled pen Trade Name: Ovaleap 900 UI/1,5 ml solucion inyectable Pharmaceutical Form: Solution

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • AFC >10 • 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).

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the two stimulation groups of Clomiphene Citrate (CC) 50mg/day plus rFSH 150IU vs. 300IU regarding the number of GQB according to the Istanbul Consensus criteria;Secondary Objective: To compare the two stimulation groups of Clomiphene Citrate (CC) 50mg/day plus rFSH 150IU vs. 300IU regarding the morphokinetic parameters of early embryo development;Primary end point(s): The primary efficacy endpoint is the number of GQB, according to the Istanbul Consensus Criteria .;Timepoint(s) of evaluation of this end point: 5-7 days from oocytes insemination procedure	—

Measure

Time frame

Main Objective: To compare the two stimulation groups of Clomiphene Citrate (CC) 50mg/day plus rFSH 150IU vs. 300IU regarding the number of GQB according to the Istanbul Consensus criteria;Secondary Objective: To compare the two stimulation groups of Clomiphene Citrate (CC) 50mg/day plus rFSH 150IU vs. 300IU regarding the morphokinetic parameters of early embryo development;Primary end point(s): The primary efficacy endpoint is the number of GQB, according to the Istanbul Consensus Criteria .;Timepoint(s) of evaluation of this end point: 5-7 days from oocytes insemination procedure

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Secondary

Measure	Time frame
Secondary end point(s): The key secondary endpoints are: 1. Time of pronuclei appearance 2. Time of pronuclei disappearance 3. The total number of embryos 4. Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8) 5. Time of compactation 6. Time of morula 7. Time of cavitation/early blast 8. Time of full blastulation 9. Time of expanded blastocyst 10. Time of hatching blastocyst 11. Blastocyst formation rate 12. Cycle cancelation rate;Timepoint(s) of evaluation of this end point: 1-7 days from oocytes insemination procedure	—

Measure

Time frame

Secondary end point(s): The key secondary endpoints are: 1. Time of pronuclei appearance 2. Time of pronuclei disappearance 3. The total number of embryos 4. Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8) 5. Time of compactation 6. Time of morula 7. Time of cavitation/early blast 8. Time of full blastulation 9. Time of expanded blastocyst 10. Time of hatching blastocyst 11. Blastocyst formation rate 12. Cycle cancelation rate;Timepoint(s) of evaluation of this end point: 1-7 days from oocytes insemination procedure

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Countries

Spain

Contacts

Public ContactUnidad de Apoyo a la Investigación

Fundacion Santiago Dexeus Font

nacrod@dexeus.com34932274700

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026