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

June 26, 2018 updated by: Merck KGaA, Darmstadt, Germany

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1064

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Darmstadt, Germany
        • Merck KGaA Communication Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Gonal-f®
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.
Other Names:
  • Recombinant human follicle stimulating hormone
Drug: Long GnRH agonist
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.
Drug: GnRH antagonist
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with polycystic ovary
Time Frame: Baseline
Baseline
Serum Testosterone levels
Time Frame: Baseline
Baseline
Number of subjects with history of menstrual disorders
Time Frame: Baseline
Baseline
Number of subjects with hirsutism
Time Frame: Baseline
Baseline
Number of oocytes retrieved
Time Frame: Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)
Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)
Time Frame: Baseline up to 1 month
Baseline up to 1 month
Daily Dose of Recombinant Follicle Stimulating Hormone (r-FSH)
Time Frame: Baseline up to 1 month
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)
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)
Biochemical pregnancy was defined as a positive pregnancy test (serum beta-hCG test) of the post-treatment assessment period
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)
Clinical pregnancy was defined as existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.
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)
Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.
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
OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, haemoconcentration, and increased blood clotting.
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
OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, haemoconcentration, and increased blood clotting.
Baseline up to 13 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Serono Co., Ltd., China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2015

Primary Completion (Actual)

March 16, 2017

Study Completion (Actual)

June 28, 2017

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 700623_547

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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