STERILITY
Conditions
Brief summary
The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro fertilisation/intracytoplasmic sperm injection). Study hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and urinary hMG (human menopausal gonadotropin)should be more effective than monotherapy.
Interventions
DRUGhMG-HP
Sponsors
Ferring SAU
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Body mass index (BMI) between 18 and 30 * Prolactin within the laboratory normal range * Couples affected by sterility able to treat by IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) * Patients undergoing Menopur® and/or Bravelle® treatment * Normal thyroid function * Women not receiving clomifen citrate or gonadotrophins within one month prior study start * Couples willing to participate in the study that have signed the informed consent form
Exclusion criteria
* Failure in 3 previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) * Policystic ovarian syndrome * Seminal samples not apt for IVF-ICSI (according to the criteria of each center) * Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months * Antecedents of severe ovarian hyperstimulation syndrome (OHSS) * Important systemic disease * Pregnancy or contraindication to pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical pregnancy rate | 0-30 days |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical pregnancy rate | 0-16 days |
Countries
Spain
Outcome results
None listed