Randomized Study stimulation of the ovaries in women with poor response expected or ovaries.

PROSPECTIVE AND RANDOMIZED STUDY FOR ASSESSMENT OF CONTROLLED OVARIAN STIMULATION WITH ALFA Corifollitropin IN PATIENTS WITH OVARIAN RESPONSE EXPECTED OR POOR IN VITRO FERTILIZATION CYCLE.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002027-42-ES

Enrollment

Unknown

Registered

2013-07-12

Start date

2013-08-14

Completion date

Unknown

Last updated

2017-10-02

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

Conditions

Women who meet the criteria for infertility Bologna

Interventions

Trade Name: ELONVA® Pharmaceutical Form: Solution for injection INN or Proposed INN: CORIFOLLITROPIN ALFA CAS Number: 195962-23-3 Concentration unit: µg microgram(s) Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients ? 18 years of age. - Patients who have previously signed consent to participate in this study. - Quen pacietnes submit one of the following factors: 1. Have a history of medical or surgical treatment as a risk factor for POR. 2. Have had a poor ovarian response in response to the EOC (previous cycle after conventional stimulation with ? 3 oocytes) 3. Are poor ovarian response wait to have abnormal ovarian reserve test: AMH =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Anovulation. - Patient with tubal factor, untreated - Patient with uterine pathology, untreated. - Couples with severe male factor, fresh count 28.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficiency of OVARTICA STIMULATION CONTROLLED by alpha Corifollitropin, in patients with expected or poor ovarian response undergoing IVF / ICSI.;Secondary Objective: To investigate the efficiency, effectiveness and safety of the EOC by CFA in patients with expected or poor ovarian response undergoing IVF / ICSI.;Primary end point(s): Tasa de gestación evolutiva /ciclo Número de ovocitos metafase II/paciente;Timepoint(s) of evaluation of this end point: During the pregnancy.	—

Measure

Time frame

Main Objective: To investigate the efficiency of OVARTICA STIMULATION CONTROLLED by alpha Corifollitropin, in patients with expected or poor ovarian response undergoing IVF / ICSI.;Secondary Objective: To investigate the efficiency, effectiveness and safety of the EOC by CFA in patients with expected or poor ovarian response undergoing IVF / ICSI.;Primary end point(s): Tasa de gestación evolutiva /ciclo Número de ovocitos metafase II/paciente;Timepoint(s) of evaluation of this end point: During the pregnancy.

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Secondary

Measure	Time frame
Secondary end point(s): Rating patient characteristics: age, BMI. ? adverse effects rating ELONVA 150. ? Assessment of the response to the EOC by: - Cancellation fee - Total dose of gonadotropins used. - Required days of stimulation. - Serum oestradiol levels on the day of hCG. - Number of follicles punctured. - Number of oocytes obtained. - Fertilization rate. - Number of viable embryos at 48h after fertilization. Embryo quality. - Number of embryos transferred - Number of frozen embryos. - Implantation rate. - Pregnancy rate / cycle started - Pregnancy rate / oocyte collection - Pregnancy rate / embryo transfer - Abortion rate ? Rating BY predictors markers before stimulation. Relating AMH values ??and RFA with no oocytes retrieved and pregnancy rate evolution. ? Cost-effectiveness evaluation to check for economic differences between the two branches in relation to the number of metaphase II oocytes per patient and evolutionary pregnancy rate per cycle;Timepoint(s) of evaluation of this end point: During the pregnancy.	—

Measure

Time frame

Secondary end point(s): Rating patient characteristics: age, BMI. ? adverse effects rating ELONVA 150. ? Assessment of the response to the EOC by: - Cancellation fee - Total dose of gonadotropins used. - Required days of stimulation. - Serum oestradiol levels on the day of hCG. - Number of follicles punctured. - Number of oocytes obtained. - Fertilization rate. - Number of viable embryos at 48h after fertilization. Embryo quality. - Number of embryos transferred - Number of frozen embryos. - Implantation rate. - Pregnancy rate / cycle started - Pregnancy rate / oocyte collection - Pregnancy rate / embryo transfer - Abortion rate ? Rating BY predictors markers before stimulation. Relating AMH values ??and RFA with no oocytes retrieved and pregnancy rate evolution. ? Cost-effectiveness evaluation to check for economic differences between the two branches in relation to the number of metaphase II oocytes per patient and evolutionary pregnancy rate per cycle;Timepoint(s) of evaluation of this end point: During the pregnancy.

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Countries

Spain

Contacts

Public ContactUREC

INSTITUTO DE INVESTIGACION SANITARIA LA FE

investigacion_clinica@iislafe.es34961246611

Outcome results

None listed

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