Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation (DESCARTES)

Ferring

Status: Completed

Conditions: STERILITY

Treatments: Drug: hMG-HP

Study type: Observational

Funder types: Industry

Identifiers

NCT01331720

FER-MEN-2006-03

Details and patient eligibility

About

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.

Enrollment: 279 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

279 participants in 5 patient groups

FSH:LH 1:1 - Treatment Group A

Description:

Patients with a condition LH (luteinizing hormone)

Treatment:

Drug: hMG-HP

FSH:LH 3:2 - Treatment Group B

Description:

Patients with a condition

Treatment:

Drug: hMG-HP

FSH:LH 3:1 - Treatment Group C

Description:

Patients with a condition

Treatment:

Drug: hMG-HP

FSH:LH 3:0 - Treatment Group D

Description:

Patients with a condition

Treatment:

Drug: hMG-HP

Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E

Description:

Patients with a condition

Treatment:

Drug: hMG-HP