Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT01298960
Eligibility Criteria:
Inclusion Criteria:
* Women who desire pregnancy with regular spontaneous menstrual cycles of 25-30 days length.
* Infertility requiring IVF with or without ICSI.
* Antecedent of a failed previous IVF cycle with a GnRH long agonist protocol in which at least 3000 IU of FSH were used (cancellation due to poor ovarian response - \< 4 mature follicles - or less than 5 oocytes retrieved)and antral follicle count \< 5.
* Partner sperm.
* Presence of both ovaries and normal uterine cavity.
* PAP smear within normality in previous 3 years.
* Negative pregnancy test (serum or urine) before rFSH administration.
* Willingness of adhesion to protocol during the whole study period.
* Signed informed consent given.
Exclusion Criteria:
* HIV, HCV, HBV positive serologies in women or partner.
* Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors...).
* BMI \> 32 kg/m2 or antecedent of diabetes mellitus.
* Gonadotrophin treatment within the previous 30 days.
* Availability of frozen embryos of previous IVF cycles .
* Abnormal uterine bleeding.
* Previous treatment with LH or LH effect drugs.
* Polycystic ovaries, increased size ovaries or presence of ovarian cysts of unknown ethiology.
* Contraindication for pregnancy.
* Allergies to gonadotrophins or somatotropin.
* History of drug or alcohol abuse in the previous 5 years.
* Previous enrollment in this study or simultaneous participation in another study with drugs.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT01298960
Study Brief:
Protocol Section:
NCT01298960