Clinical trial NCT01331720: Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation
Official title: Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation Protocols Which Are the Most Common in Clinical Practice Using High Purified Gonadotrophins (u-FSH-HP y u-hMG-HP) in IVF/ICSI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STERILITY
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring SAU
First posted: 2011-04-08
Enrollment: 279
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females affected by sterility able to undergo IVF/ICSI

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 0-30 days
Secondary outcomes:
measure: Biochemical pregnancy rate
timeFrame: 0-16 days
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Investigational site
state: Alicante
city: Gijón
country: Spain
facility: Investigational site
state: Asturias
city: Santiago de Compostela
country: Spain
facility: Investigational site
state: La Coruña
city: Navarra
country: Spain
facility: Investigational site
state: Pamplona
city: Albacete
country: Spain
facility: Investigational site
city: Alicante
country: Spain
facility: Investigational site
city: Badajoz
country: Spain
facility: Investigational site
city: Castellón
country: Spain
facility: Investigational site
city: Mallorca
country: Spain
facility: Investigational site
city: Murcia
country: Spain
facility: Investigational site
city: Málaga
country: Spain
facility: Investigational site
city: Tenerife
country: Spain
facility: Investigational site Sta. Cruz
city: Valencia
country: Spain
facility: Investigational site
city: Zaragoza
country: Spain
facility: Investigational site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: