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

NCT02607293 | Completed DMC

• 1 other identifier: 700623_547
• Study Type: observational
• Target: 1,064
• Locations: 1 country
• Sites: 1

Brief 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 (iCOS).

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; Gonadotropin releasing hormone agonist (GnRH-a); Gonal-f; Assisted Reproductive Technology

Outcome Measures

Primary Outcomes (5)

• Number of subjects with polycystic ovary

  Baseline

• Serum Testosterone levels

  Baseline

• Number of subjects with history of menstrual disorders

  Baseline

• Number of subjects with hirsutism

  Baseline

• Number of oocytes retrieved

  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)

  Baseline up to 1 month

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

  Baseline up to 1 month

• Number of Metaphase II (M II) oocyte retrieved

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

• Biochemical pregnancy rate

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

• Clinical pregnancy rate

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

Study Arms (1)

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®; Drug: Long GnRH agonist; Drug: GnRH antagonist

Interventions

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.

Also known as: Recombinant human follicle stimulating hormone

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

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.

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

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.

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

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Co., Ltd., China: collaborator

Study Sites (1)

Merck KGaA Communication Center

Darmstadt, Germany

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

follitropin alfa; LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Responsible

  Merck Serono Co., Ltd., China

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 18, 2015
• Study Start: December 31, 2015
• Primary Completion: March 16, 2017
• Study Completion: June 28, 2017
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

DE (1)