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.
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.
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).
- Conditions
- Polycystic Ovary Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| Subjects undergoing ART treatment with long GnRH-a or GnRH-ant | Subjects 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.
Number of subjects with polycystic ovary
Measured: Baseline
Serum Testosterone levels
Measured: Baseline
Number of subjects with history of menstrual disorders
Measured: Baseline
Number of subjects with hirsutism
Measured: Baseline
Number of oocytes retrieved
Measured: Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)
Secondary outcomes (8)
Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)
Measured: Baseline up to 1 month
Daily Dose of Recombinant Follicle Stimulating Hormone (r-FSH)
Measured: Baseline up to 1 month
Number of Metaphase II (M II) oocyte retrieved
Measured: Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)
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)
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)
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)
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
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.
- First posted18 Nov 2015 (estimated)
- Study start31 Dec 2015
- Primary completion16 Mar 2017
- Study completion28 Jun 2017
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,064 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono Co., Ltd., China
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Serono Co., Ltd., China
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02607293
- Acronym / sponsor ID
- ARTIST / 700623_547
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Gonadotropin releasing hormone agonist (GnRH-a), Gonal-f, Assisted Reproductive Technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,064 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono Co., Ltd., China
- Study start
- 31 Dec 2015 (actual)
- Primary completion
- 16 Mar 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 18 Nov 2015 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects undergoing ART treatment with long GnRH-a or GnRH-ant | – | Drug: Gonal-f®, Drug: Long GnRH agonist, Drug: GnRH antagonistSubjects 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Gonal-f®Also: Recombinant human follicle stimulating hormoneRecombinant 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. | Drug | Subjects undergoing ART treatment with long GnRH-a or GnRH-ant |
| Long GnRH agonistAs 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. | Drug | Subjects undergoing ART treatment with long GnRH-a or GnRH-ant |
| GnRH antagonistAs 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. | Drug | Subjects undergoing ART treatment with long GnRH-a or GnRH-ant |
Primary outcome
Number of subjects with polycystic ovary
Time frame: Baseline
Serum Testosterone levels
Time frame: Baseline
Number of subjects with history of menstrual disorders
Time frame: Baseline
Number of subjects with hirsutism
Time frame: Baseline
Number of oocytes retrieved
Time frame: Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)
8 secondary outcomes
Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)
Time frame: Baseline up to 1 month
Daily Dose of Recombinant Follicle Stimulating Hormone (r-FSH)
Time frame: Baseline up to 1 month
Number of Metaphase II (M II) oocyte retrieved
Time frame: Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)
Biochemical pregnancy rate
Time frame: 4 to 6 Weeks after Embryo transfer (Up to 4 months)
Clinical pregnancy rate
Time frame: 4 to 6 Weeks after Embryo transfer (Up to 4 months)
Implantation Rate
Time frame: 4 to 6 Weeks after Embryo transfer (Up to 4 months)
Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)
Time frame: Baseline up to 13 month
Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)
Time frame: Baseline up to 13 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
Related trials for Polycystic Ovary Syndrome
Active, not recruitingObservational study
Association Between Polycystic Ovary Syndrome and Sleep Quality: A Questionnaire-Based Study
Sleep Disorder, Polycystic Ovarian Syndrome (PCOS)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Not yet recruitingObservational study
Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks
Obesity & Overweight, Diabetes Mellitus, Type 2
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for PCOS
Polycystic Ovary Syndrome (PCOS), Polycystic Ovary Syndrome
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.
Medical Responsible study director
Merck Serono Co., Ltd., China
1 site in 1 country: see every site and its status.
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?
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.