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

NCT02785822 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-02-25

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

hMG-HP

Ovarian stimulation with hMG-HP (150 IU / day)

DRUG

hFSH-HP

Ovarian stimulation with hFSH-HP (150 IU / day)

Sponsors & Collaborators

  • Programa de Reproducción Asistida F. Puigvert - HSCSP

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-23
Primary Completion
2018-05-09
Completion
2018-05-09

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02785822 on ClinicalTrials.gov