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

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Terminated
CT.gov ID
NCT02785822
Collaborator
Programa de Reproducción Asistida F. Puigvert - HSCSP (Other)
19
Enrollment
2
Locations
2
Arms
14.5
Actual Duration (Months)
9.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized, Single Blind, Prospective Clinical Study to Compare hFSH-HP (Fostipur) and hMG-HP(Meriofert) in Patients With Polycystic Ovary Under a IVF/ICSI Cycle.
Actual Study Start Date :
Feb 23, 2017
Actual Primary Completion Date :
May 9, 2018
Actual Study Completion Date :
May 9, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Fostipur

Drug: hFSH-HP
Ovarian stimulation with hFSH-HP (150 IU / day)
Other Names:
  • Fostipur

    		•
    Experimental: Meriofert

    Drug: hMG-HP
    Ovarian stimulation with hMG-HP (150 IU / day)
    Other Names:
  • Meriofert

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quantity of mature oocytes respect to the total oocytes [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fundació Puigvert Barcelona Spain 08025
    2 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08026

    Sponsors and Collaborators

    • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    • Programa de Reproducción Asistida F. Puigvert - HSCSP

    Investigators

    • Study Chair: Juan J Espinos, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    ClinicalTrials.gov Identifier:
    NCT02785822
    Other Study ID Numbers:
    • IIBSP-FOS-2016-01
    First Posted:
    May 30, 2016
    Last Update Posted:
    Feb 25, 2019
    Last Verified:
    Feb 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    Reproductive Techniques, Assisted
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome

    Study Results

    No Results Posted as of Feb 25, 2019