Polycystic Ovary SyndromePhase 4NCT02785822
Study to Compare hFSH-HP (Fostipur) and hMG-HP(Meriofert) in Patients With Polycystic Ovary Under a IVF/ICSI Cycle.
A Phase 4 study testing hMG-HP and hFSH-HP in people with Polycystic Ovary Syndrome, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- hMG-HP and hFSH-HP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesSpain
- Study dates
- 23 Feb 2017to 9 May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Fundació Puigvert
Barcelona, 08025
Hospital de la Santa Creu i Sant Pau
Barcelona, 08026
About this study
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.
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
- Being tested
- hMG-HP, hFSH-HP
- Keywords
- Reproductive Techniques, Assisted
- Medical subject headings
- Polycystic Ovary Syndrome, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hMG-HPDrug
Also called Meriofert
Ovarian stimulation with hMG-HP (150 IU / day)
hFSH-HPDrug
Also called Fostipur
Ovarian stimulation with hFSH-HP (150 IU / day)
| Study group | Role | What they receive |
|---|---|---|
| Fostipur | Active comparator | Not described Receives: Drug: hFSH-HP |
| Meriofert | Experimental | Not described Receives: Drug: hMG-HP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of mature oocytes respect to the total oocytes
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study start23 Feb 2017
- Primary completion9 May 2018
- Study completion9 May 2018
Why it stopped: Difficulties in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Programa de Reproducción Asistida F. Puigvert - HSCSP
- Responsible party
- Sponsor
- Investigators
- Juan J Espinos, MD, Study chair, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785822
- Sponsor's protocol ID
- IIBSP-FOS-2016-01
- Status last verified
- Feb 2019
- First submitted
- 25 May 2016
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02785822
- Acronym / sponsor ID
- IIBSP-FOS-2016-01
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Reproductive Techniques, Assisted
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Programa de Reproducción Asistida F. Puigvert - HSCSP
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 30 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fostipur | Active comparator | Drug: hFSH-HP |
| Meriofert | Experimental | Drug: hMG-HP |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hMG-HPAlso: MeriofertOvarian stimulation with hMG-HP (150 IU / day) | Drug | Meriofert |
| hFSH-HPAlso: FostipurOvarian stimulation with hFSH-HP (150 IU / day) | Drug | Fostipur |
Primary outcome
Quantity of mature oocytes respect to the total oocytes
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Difficulties in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
Related trials for Polycystic Ovary Syndrome
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan J Espinos, MD study chair
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hMG-HP and hFSH-HP in people with Polycystic Ovary Syndrome, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of mature oocytes respect to the total oocytes (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.