Status:
COMPLETED
Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono S.A.S, France
Conditions:
Polycystic Ovarian Syndrome
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
Brief 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 0.2...
Detailed Description
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 sp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT01185704
Start Date
November 1 2008
End Date
February 1 2012
Last Update
February 13 2014
Active Locations (1)
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1
Research Site
Toulouse, France