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Lutropin alfa in mid follicular phase in women at risk of poor response suppresed with cetrorelix: an exploratory trial.Lutropina alfa en mitad de la fase folicular en mujeres con riesgo de pobre respuesta en supresión con cetrorelix: estudio exploratorio - Lutropin alfa in risk of poor response.

Lutropin alfa in mid follicular phase in women at risk of poor response suppresed with cetrorelix: an exploratory trial.Lutropina alfa en mitad de la fase folicular en mujeres con riesgo de pobre respuesta en supresión con cetrorelix: estudio exploratorio - Lutropin alfa in risk of poor response.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002229-30-ES
Enrollment
60
Registered
2005-07-11
Start date
2005-09-19
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Controlled ovarian stimulation in assisted fertilisation. PT: assisted Fertilisation MedDRA version: 7.0 Level: PT Classification code 10003539

Interventions

Trade Name: Luveris 75 IU Product Name: Luveris 75 UI Product Code: Not applicable Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Lutropin alfa Other descripti

Sponsors

Serono España, S.A.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Pre-menopausal women, aged =38, wishing to conceive. 2. Infertility justifying ICSI-TE treatment. 3. At risk of poor response criteria due to previous poor response, cancellation of previous cycles or FSH levels. 4. Having regular spontaneous menstrual cycle lasting 25-35 days. 5. To be included under GnRH antagonist protocol. Are the trial subjects under 18? 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 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Known to be HIV, HBV/HCV positive. 2. Any clinically significant systemic disease; tumours of the hypotalamus and pituitary gland; ovarian, uterine or mammary cancer; hormonal abnormality and/or medical, biochemical, hematological condition which in the judgement of the investigator may interfere with gonadotropin treatment. 3. More than 3 previous ART cycles. 4. Cryopreserved embryos from previous cycles with the same partner.

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the efficacy of lutropin alfa addition when a follicle =14 mm is observed versus no addition of r-hLH in patients at risk of poor response undergoing controlled ovarian stimulation with a GnRH antagonist prior to ICSI-TE, in terms of total number and metaphase II oocytes retrieved.;Secondary Objective: Assess the safety of using lutropin alfa in combination with r-hFSH in this population including incidence of ovarian hyperstimulation syndrome (OHSS) and adverse events as well as local tolerance.;Primary end point(s): Total number and metaphase II oocytes retrieved and number of metaphase II oocytes divided by the total number of oocytes retrieved.—

Countries

Spain

Outcome results

None listed

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