Clinical trial NCT02607293: A Study to Explore Correlation Between Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response to Ovarian Stimulation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Gonadotropin releasing hormone agonist (GnRH-a)
Gonal-f
Assisted Reproductive Technology
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Co., Ltd., China
First posted: 2015-11-18
Enrollment: 1064
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with polycystic ovary
timeFrame: Baseline
measure: Serum Testosterone levels
timeFrame: Baseline
measure: Number of subjects with history of menstrual disorders
timeFrame: Baseline
measure: Number of subjects with hirsutism
timeFrame: Baseline
measure: Number of oocytes retrieved
timeFrame: Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)
Secondary outcomes:
measure: Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)
timeFrame: Baseline up to 1 month
measure: Daily Dose of Recombinant Follicle Stimulating Hormone (r-FSH)
timeFrame: Baseline up to 1 month
measure: Number of Metaphase II (M II) oocyte retrieved
timeFrame: Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)
measure: Biochemical pregnancy rate
timeFrame: 4 to 6 Weeks after Embryo transfer (Up to 4 months)
measure: Clinical pregnancy rate
timeFrame: 4 to 6 Weeks after Embryo transfer (Up to 4 months)
measure: Implantation Rate
timeFrame: 4 to 6 Weeks after Embryo transfer (Up to 4 months)
measure: Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)
timeFrame: Baseline up to 13 month
measure: Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)
timeFrame: Baseline up to 13 month
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Merck KGaA Communication Center
Study officials:
affiliation: Merck Serono Co., Ltd., China
name: Medical Responsible
role: STUDY_DIRECTOR
References: