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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: GnRH antagonist; Drug: Long GnRH agonist; Drug: Gonal-f®

Study type: Observational

Funder types: Industry

Identifiers

NCT02607293

700623_547

Details and patient eligibility

About

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).

Enrollment: 1,064 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,064 participants in 1 patient group

Subjects undergoing ART treatment with long GnRH-a or GnRH-ant

Description:

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.

Treatment:

Drug: Gonal-f®

Drug: Long GnRH agonist

Drug: GnRH antagonist