Study to Compare hFSH-HP (Fostipur) and hMG-HP(Meriofert) in Patients With Polycystic Ovary Under a IVF/ICSI Cycle.

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status and phase

Terminated

Phase 4

Conditions

Polycystic Ovary Syndrome

Treatments

Drug: hMG-HP

Drug: hFSH-HP

Study type

Interventional

Funder types

Other

Identifiers

NCT02785822

IIBSP-FOS-2016-01

Details and patient eligibility

About

Polycystic ovary occurs in 15-20% of the population will be submitted to TRA. Whether it is associated with other signs or symptoms (polycystic ovarian syndrome) as if presented in isolation, its therapeutic management has special connotations sometimes favoring the low response although the standard is the tendency to hyperresponsiveness.

Although there are studies comparing the combination of FSH and LH and FSH in controlled hyperstimulation of these patients, there are no previous prospective randomized studies comparing administration of urinary FSH (hFSH-HP) with a combination of FSH and HCG (HMG HP).

Therefore the aim of this study is to prove that both drugs are comparable in the treatment of these patients. The test substances are marketed in Spain (Fostipur and Meriofert, respectively) with an indication for use in these patients. In this study both medicines will be administered in a randomized way under the usual conditions in which it is used in routine clinical practice to compare the quantity of mature oocytes respect to the total oocytes obtained, as a primary outcome measure.

Enrollment

19 patients

Sex

Female

Ages

18 to 38 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female age between 18 and 38 years (inclusive)
Women with a BMI under 30 kg / m2
Diagnosis of polycystic ovary syndrome (according to criteria of Rotterdam)
Women who want pregnancy
Basal basal FSH levels under or equal 10 IU / l
Infertility justify treatment with in vitro fertilization / intracytoplasmic sperm injection
To be included in a protocol with GnRH antagonist
Presence of both ovaries and uterus able to support embryo implantation and pregnancy
Absence of pregnancy before starting ovarian stimulation
Written consent

Exclusion criteria

Severe male factor not allowing an in vitro fertilization / intracytoplasmic sperm injection with ejaculated sample
Patients with low ovarian reserve
Important endocrine-metabolic systemic diseases affecting pituitary, thyroid, adrenals, pancreas, liver or kidney
HIV seropositivity
To have frozen embryos from previous cycles of assisted reproduction
Undiagnosed vaginal haemorrhage
Poor response in previous cycles of in vitro fertilization with standard stimulation protocols
Pregnancy, lactation or contraindication to get pregnant
Malformations of the sexual organs incompatible with pregnancy
History of allergy to gonadotrophin preparations or its excipients
Alcohol, drugs or psychotropic addiction
Concurrent participation in another study
Previous history of severe hyperstimulation syndrome
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