Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)

Launched by MERCK KGAA, DARMSTADT, GERMANY · Aug 19, 2010

Keywords

ClinConnect Summary

Polycystic ovarian syndrome population is an androgenic syndrome characterized by a wide spectrum of clinical manifestations such as obesity, hirsutism, insulin resistance, diabetes and presence of specific ultrasonic features.

Cetrotide®, cetrorelix acetate, is an antagonist of luteinizing-hormone-releasing hormone (LHRH). Cetrotide® is registered in 70 countries (including France) for the prevention of premature ovulation in subjects undergoing a controlled ovarian stimulation, followed by oocyte pick-up and ARTs. Ovitrelle®, active ingredient human chorionic-gonadotropin alfa, is admini...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female subjects with PCO or Polycystic ovary syndrome (PCOS) according to the revised 2003 Rotterdam Consensus
• • Female subjects suitable for IVF/ICSI, undergoing first or second attempt
• • 18-35 years old, Body Mass Index (BMI) less than or equal to 32, non-smoking at least from Visit 0 (V0)
• • Normal FSH value (less than 10 international unit per liter \[IU/L\]) on Day 3 of spontaneous cycle within 12 months prior to the trial
• • Anti Mullerian Hormone (AMH) value (greater than 1.5 nanogram per milliliter \[ng/mL\]) of a spontaneous cycle within 12 months prior to the trial or at least at V0
• • No history of active genito-urinary infection
• • Normal thyroid function (or adequate substitution for at least 3 months)
• • Negative cervical papanicolaou test within the last 12 months prior to study entry
• • No gonadotropins, for at least one month prior to the trial
• • No metformin therapy for at least one month prior to Visit 1 (V1)
• • Subject who is able to participate in the trial and has provided written, informed consent.
• Exclusion Criteria:
• • Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term
• • Drilling 3 months prior to V0
• • Uterine malformation, diethylstilbestrol syndrome, synechia
• • Female subjects with World Health Organization (WHO) Type I or III anovulation
• • Female subjects with hyperprolactinemia
• • Female subjects with more than 2 recurrent miscarriages (early or late, and for any reasons)
• • Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus, for subject or partner
• • Abnormal gynecological bleeding of undetermined origin
• • History of major thromboembolic disease
• • Endometriosis (Grade III or IV)
• • Presence or history of malignant tumors and related treatment
• • Known case of tumors of the hypothalamus or pituitary gland
• • Clinically significant systemic disease or clinically significant abnormal hematology, chemistry, or urinalysis results at screening
• • Known allergic reaction or hypersensitivity to Cetrotide® or Ovitrelle®
• • Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years
• • Participation in another clinical trial within 3 months prior to study entry.