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

Primary Purpose

Polycystic Ovary Syndrome

Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
hMG-HP
hFSH-HP
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Reproductive Techniques, Assisted

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Fundació Puigvert
  • Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fostipur

Meriofert

Arm Description

Outcomes

Primary Outcome Measures

Quantity of mature oocytes respect to the total oocytes

Secondary Outcome Measures

Full Information

First Posted
May 25, 2016
Last Updated
February 21, 2019
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Programa de Reproducción Asistida F. Puigvert - HSCSP
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1. Study Identification

Unique Protocol Identification Number
NCT02785822
Brief Title
Study to Compare hFSH-HP (Fostipur) and hMG-HP(Meriofert) in Patients With Polycystic Ovary Under a IVF/ICSI Cycle.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in recruitment
Study Start Date
February 23, 2017 (Actual)
Primary Completion Date
May 9, 2018 (Actual)
Study Completion Date
May 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Programa de Reproducción Asistida F. Puigvert - HSCSP

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Reproductive Techniques, Assisted

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fostipur
Arm Type
Active Comparator
Arm Title
Meriofert
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
hMG-HP
Other Intervention Name(s)
Meriofert
Intervention Description
Ovarian stimulation with hMG-HP (150 IU / day)
Intervention Type
Drug
Intervention Name(s)
hFSH-HP
Other Intervention Name(s)
Fostipur
Intervention Description
Ovarian stimulation with hFSH-HP (150 IU / day)
Primary Outcome Measure Information:
Title
Quantity of mature oocytes respect to the total oocytes
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan J Espinos, MD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Study Chair
Facility Information:
Facility Name
Fundació Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08026
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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