NCT02785822

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

February 23, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2018

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

May 25, 2016

Last Update Submit

February 21, 2019

Conditions

Polycystic Ovary Syndrome

Keywords

Reproductive Techniques, Assisted

Outcome Measures

Primary Outcomes (1)

  • Quantity of mature oocytes respect to the total oocytes

    30 days

Study Arms (2)

Fostipur

ACTIVE COMPARATOR
Drug: hFSH-HP

Meriofert

EXPERIMENTAL
Drug: hMG-HP

Interventions

hMG-HPDRUG

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

Also known as: Meriofert
Meriofert
hFSH-HPDRUG

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

Also known as: Fostipur
Fostipur

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fundació Puigvert

Barcelona, 08025, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeHelping Behavior

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesSocial BehaviorBehavior

Study Officials

  • Juan J Espinos, MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

May 30, 2016

Study Start

February 23, 2017

Primary Completion

May 9, 2018

Study Completion

May 9, 2018

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

ES(2)