randomized, single blind, prospective clinical study to compare hFSH-HP (Fostipur) and hMG-HP (Menopur) in patients with polycystic ovary ander a FIV/ICSI cicle

Conditions: women with polycystic ovary under a cicle of FIV/ICSI.
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

Registration Number: EUCTR2014-005099-27-ES

Lead Sponsor: Institut de Recerca de l?Hospital de la Santa Creu i Sant Pau ? IIB Sant Pau

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

1. Female age between 18 and 38 years (inclusive)
2. Women with a BMI under 30 kg / m2
3. Diagnosis of PCOS or polycystic ovary syndrome (according to criteria of Rotterdam)
4. Women who want pregnancy
5. basal basal FSH levels under or equal 10 IU / l
6. Infertility justify treatment with FIV / ICSI-ET
7. To be included in a protocol with GnRH antagonist
8. Presence of both ovaries and uterus able to support embryo implantation and pregnancy
9. Absence of pregnancy before starting ovarian stimulation
10. Having given written consent
Are the trial subjects under 18? no
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 164
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. severe male factor not allowing an FIV / ICSI with ejaculated sample
2. Patients with low ovarian reserve
3. important endocrine-metabolic systemic diseases affecting pituitary, thyroid, adrenals, pancreas, liver or kidney
4. HIV seropositivity
5. to have frozen embryos from previous cycles of assisted reproduction
6. undiagnosed vaginal haemorrhage
7. Poor response in previous cycles of FIV with standard stimulation protocols
8. Pregnancy, lactation or contraindication to get pregnant
9. Malformations of the sexual organs incompatible with pregnancy
10. History of allergy to gonadotrophin preparations or its excipients
11. Alcohol, drugs or psychotropic addiction
12. Concurrent participation in another study
13. Previous history of severe hyperstimulation syndrome
14. Concomitant medication that may interfere with the study medication: different hormonal treatments used in the study, other thyroid hormones, antipsychotics, anxiolytics, hypnotics, sedatives, chronic treatment with inhibitors of prostaglandin