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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized open-label study to compare between in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of Cetrotide® (Cetrorelix acetate) which are 0.25 milligram (mg) used from Day 1 or Day 7 of the menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in assisted reproductive technology (ART).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono S.A.S, France
• Treatments: Cetrorelix; Chorionic Gonadotropin; Follicle Stimulating Hormone; Hormones

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.