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TerminatedNCT02785822Updated Feb 25, 2019

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

A Phase 4 interventional study of hMG-HP and hFSH-HP in Polycystic Ovary Syndrome, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Terminated at 2 sites in Spain. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2019-02-25.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Phase 4, Interventional, and Treatment

Why this study was terminated
Difficulties in recruitment
Phase
Phase 4
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 38 Years
Sex
Female
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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.

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Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • Reproductive Techniques, Assisted
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In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's enrollment of 19 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 38 Years
Sexes eligible
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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
19 participants (actual)

Study arms

  • Active comparator
    Fostipur

    Drug: hFSH-HP

  • Experimental
    Meriofert

    Drug: hMG-HP

Interventions

  • DrughMG-HP

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

    Also known as: Meriofert

  • DrughFSH-HP

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

    Also known as: Fostipur

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What researchers measure

Primary outcomes

  1. Quantity of mature oocytes respect to the total oocytes

    Time frame: 30 days

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Study locations

2 sites
  • Fundació Puigvert
    Barcelona, 08025, Spain
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 08026, Spain
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02785822
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Programa de Reproducción Asistida F. Puigvert - HSCSP
Responsible party
Sponsor
First posted
May 30, 2016
Start date
Feb 23, 2017
Primary completion
May 9, 2018
Completion
May 9, 2018
Last update
Feb 25, 2019

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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