Prospective randomized trial concerning three different stimulation methods in IVF/ICSI treatment in poor responders

Prospective randomized trial concerning three different stimulation methods in IVF/ICSI treatment in poor responders - POOR RESPONDERS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001708-39-BE

Enrollment

Registered

2012-04-17

Start date

2012-06-07

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Subfertility MedDRA version: 14.1 Level: LLT Classification code 10016465 Term: Fertility female decreased System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 14.1 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Elonva Pharmaceutical Form: Injection INN or Proposed INN: Corifollitropin alfa Concentration unit: µg microgram(s) Concentration type: range Concentration number: 100-150 Trade Name: Pur

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Patients undergoing a treatment with Preimplantation Genetic Diagnosis or ICIS with cryo-TESE

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to test the hypothesis that ovarian stimulation with Corifollitropin alfa FSH with a prolonged activity) in women who showed a poor ovarian repsonse in the previous IVF/ICSI cycle, results in a higher chance on a live birth;Secondary Objective: Pregnancy rate per IVF/ICSI cycle started in the trial Number of oocytes per IVF/ICSI cycle started in the trial Percentage of cycles withou oocyte aspiration due to abscence of ovarian repsonse Embryo quality (absolute number and percentage of good quality embryos);Primary end point(s): Percentage of live births per IVF/ICSI cycle started in the trial;Timepoint(s) of evaluation of this end point: About 9 months after the start of the IVF/ICSI cycle in case of a pregnancy	—

Measure

Time frame

Main Objective: The main objective is to test the hypothesis that ovarian stimulation with Corifollitropin alfa FSH with a prolonged activity) in women who showed a poor ovarian repsonse in the previous IVF/ICSI cycle, results in a higher chance on a live birth;Secondary Objective: Pregnancy rate per IVF/ICSI cycle started in the trial Number of oocytes per IVF/ICSI cycle started in the trial Percentage of cycles withou oocyte aspiration due to abscence of ovarian repsonse Embryo quality (absolute number and percentage of good quality embryos);Primary end point(s): Percentage of live births per IVF/ICSI cycle started in the trial;Timepoint(s) of evaluation of this end point: About 9 months after the start of the IVF/ICSI cycle in case of a pregnancy

—

Secondary

Measure	Time frame
Secondary end point(s): Pregnancy rate per IVF/ICSI cycle in the trial Number of oocytes per IVF/ICSI cycle in the trial Percentage of cycles without oocyte aspiration due to absence of ovarian response Embyro quality (absolute number and percentage of good quality embryos;Timepoint(s) of evaluation of this end point: The result 'pregnant/not pregnant' is determinated at maximum 8 weeks after the start of the IVF/ICIS cycle Number of oocyte is registered after a maximum of 22 days of ovarian stimulation The 'occurence/non occurence of oocyte aspiration due to the absence of ovarina response' is registered after a maximum of 22 days of ovarian stimualtion Embryo quality is registered until a maximum of 7 days after the oocyte aspiration	—

Measure

Time frame

Secondary end point(s): Pregnancy rate per IVF/ICSI cycle in the trial Number of oocytes per IVF/ICSI cycle in the trial Percentage of cycles without oocyte aspiration due to absence of ovarian response Embyro quality (absolute number and percentage of good quality embryos;Timepoint(s) of evaluation of this end point: The result 'pregnant/not pregnant' is determinated at maximum 8 weeks after the start of the IVF/ICIS cycle Number of oocyte is registered after a maximum of 22 days of ovarian stimulation The 'occurence/non occurence of oocyte aspiration due to the absence of ovarina response' is registered after a maximum of 22 days of ovarian stimualtion Embryo quality is registered until a maximum of 7 days after the oocyte aspiration

—

Countries

Belgium

Contacts

Public ContactClinical Trial Center

University Hospital Leuven

CTC@uzleuven.be3216341998

Outcome results

None listed

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