utropin 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.
- Conditions
- Controlled ovarian stimulation in assisted fertilisation.PT: assisted FertilisationMedDRA version: 7.0Level: PTClassification code 10003539
- Registration Number
- EUCTR2005-002229-30-ES
- Lead Sponsor
- Serono España, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method