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Completed

NCT Number: NCT02607293

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

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).

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Merck KGaA Communication Center

Darmstadt, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gonal-F®

Drug

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

Long GnRH agonist

Drug

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 antagonist

Drug

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.

Primary outcomes

  1. Number of subjects with polycystic ovary

    Time frame: Baseline

  2. Serum Testosterone levels

    Time frame: Baseline

  3. Number of subjects with history of menstrual disorders

    Time frame: Baseline

  4. Number of subjects with hirsutism

    Time frame: Baseline

  5. Number of oocytes retrieved

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

Secondary outcomes

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

    Time frame: Baseline up to 1 month

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

    Time frame: Baseline up to 1 month

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

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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Serono Co., Ltd., China

Registry information

Official study 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

Acronym: ARTIST

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 18, 2015
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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