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

February 21, 2019 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Fundacio Puigvert
      • Barcelona, Spain, 08026
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantity of mature oocytes respect to the total oocytes
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2017

Primary Completion (Actual)

May 9, 2018

Study Completion (Actual)

May 9, 2018

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

May 30, 2016

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-FOS-2016-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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