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Polycystic Ovary SyndromeARTISTNCT02607293

A Study to Explore Correlation Between Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response to Ovarian Stimulation

An observational study of Polycystic Ovary Syndrome, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase IV, prospective, observational, single arm, multicenter trial to identify the population at high risk of overstimulation associated with signs and symptoms of PCOS and examines the utility of 12.5 international units (IU) increment of Gonal-f® new pen for individualized controlled ovarian stimulation… Read more about this study

Who is it for?
Ages 20 to 35 years, women only
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Gonal-f®, Long GnRH agonist and GnRH antagonist
Type of treatment
Injection or infusion
How many people
1,064 participants
Where
1 siteGermany
Study dates
31 Dec 2015to 28 Jun 2017
Phase
Observational
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 20 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Infertile women undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol using Gonal-f® new pen who are expected to be normal or high responders.

Who may be able to join

  • Female subjects aged 20 to 35 years (including both)
  • Subjects undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol + Gn + human chorionic gonadotropin (hCG)
  • Subject from whom a written informed consent has been obtained with the understanding that the subject may withdraw consent at any time without prejudice to future medical care

Who cannot join

  • Subjects undergoing ART treatment with mild stimulation protocol
  • Concomitant use of Gonal-f® with clomiphene citrate
  • With an In vitro fertilisation (IVF)/ Intracytoplasmic sperm injection (ICSI) history of greater than or equal to (>=) 3 times
  • Known history of poor ovarian response in a previous COS cycle for IVF/ICSI, defined as less than 4 oocytes retrieved or history of previous cycle cancellation prior to oocyte retrieval due to poor response or poor ovarian reserve, such as Antral follicle count (AFC) less than (<) 5 to 7
  • Presence of confirmed or suspected endometriosis Grade III - IV
  • Presence of unilateral or bilateral hydrosalpinx
Show all 13Show fewer
  • Using other Gn during stimulation period (such as urinary FSH/human menopausal Gn, except for recombinant luteinizing hormone (r-LH))
  • Known history of recurrent miscarriage
  • Any contradiction to Gn/GnRH analogues
  • Any major systemic disease that as per Investigator's discretion precludes subject for participation in the study
  • According to the judgment of the Investigator, any medical condition or any concomitant
  • surgery/ medications that would interfere with evaluation of study medications
  • Simultaneous participation in another clinical study

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Merck KGaA Communication Center

    Darmstadt

Other trials in Germany

About this study

Official title: An Exploratory Study to Explore the Correlation Between the Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response Using New Gonal-f® Pen in Assisted Reproductive Technology (ART) Treatment in China

This is a Phase IV, prospective, observational, single arm, multicenter trial to identify the population at high risk of overstimulation associated with signs and symptoms of PCOS and examines the utility of 12.5 international units (IU) increment of Gonal-f® new pen for individualized controlled ovarian stimulation (iCOS).

Being tested
Gonal-f®, Long GnRH agonist, GnRH antagonist
Keywords
Polycystic Ovary Syndrome, Gonadotropin releasing hormone agonist (GnRH-a), Gonal-f, Assisted Reproductive Technology
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gonal-f®Drug

    Also called Recombinant human follicle stimulating hormone

    Recombinant human follicle stimulating hormone (r-FSH) will be administered subcutaneously (SC) for about 10 to 20 days along with the ART regimen as routinely practiced by Investigators and according to licensed summary of product characteristics (SmPC label) for the ovarian stimulation.

  • Long GnRH agonistDrug

    As a part of the ART regimen GnRH-agonist will be administered for about 14 to 20 days until down regulation is satisfied as judged by investigator.

  • GnRH antagonistDrug

    As a part of ART regimen GnRH-antagonist will be initiated and regimen will be as routinely practiced by Investigators and according to licensed SmPC label.

Study groups in NCT02607293
Study groupRoleWhat they receive
Subjects undergoing ART treatment with long GnRH-a or GnRH-antSubjects undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol + Gn + human chorionic gonadotropin (hCG) as per routine clinical practice. No visits or intervention(s) additional to the routine practice of the Investigators will be performed during this observational study.
Receives: Drug: Gonal-f®; Drug: Long GnRH agonist; Drug: GnRH antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with polycystic ovary

    Measured: Baseline

  2. Serum Testosterone levels

    Measured: Baseline

  3. Number of subjects with history of menstrual disorders

    Measured: Baseline

  4. Number of subjects with hirsutism

    Measured: Baseline

  5. Number of oocytes retrieved

    Measured: Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)

Secondary outcomes (8)

  1. Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)

    Measured: Baseline up to 1 month

  2. Daily Dose of Recombinant Follicle Stimulating Hormone (r-FSH)

    Measured: Baseline up to 1 month

  3. Number of Metaphase II (M II) oocyte retrieved

    Measured: Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)

  4. Biochemical pregnancy rate

    Biochemical pregnancy was defined as a positive pregnancy test (serum beta-hCG test) of the post-treatment assessment period

    Measured: 4 to 6 Weeks after Embryo transfer (Up to 4 months)

  5. Clinical pregnancy rate

    Clinical pregnancy was defined as existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.

    Measured: 4 to 6 Weeks after Embryo transfer (Up to 4 months)

  6. Implantation Rate

    Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.

    Measured: 4 to 6 Weeks after Embryo transfer (Up to 4 months)

  7. Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)

    OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, haemoconcentration, and increased blood clotting.

    Measured: Baseline up to 13 month

  8. Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)

    OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, haemoconcentration, and increased blood clotting.

    Measured: Baseline up to 13 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2015 (estimated)
  2. Study start31 Dec 2015
  3. Primary completion16 Mar 2017
  4. Study completion28 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
1,064 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02607293
Sponsor's protocol ID
700623_547
Acronym
ARTIST
Status last verified
Jun 2018
First submitted
16 Nov 2015
Last updated
28 Jun 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Polycystic Ovary Syndrome, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.

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 3 inclusion and 13 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: finished, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of subjects with polycystic ovary (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02607293.

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 28 Jun 2018; AzTrials last refreshed its copy on 27 Oct 2026.

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