A Phase IIIb Randomized Open-label Study to Compare Between IVF/ICSI Outcomes Two Regimen of Cetrotide® 0.25 mg Used From Day 1 or From Day 7 of the Menstrual Cycle (Day 0 or Day 6 of Stimulation) in Polycystic Ovarian (PCO) Women in ART.
18 Years
35 Years
Female
Polycystic Ovary Syndrome
Trial Information
A Phase IIIb Randomized Open-label Study to Compare Between IVF/ICSI Outcomes Two Regimen of Cetrotide® 0.25 mg Used From Day 1 or From Day 7 of the Menstrual Cycle (Day 0 or Day 6 of Stimulation) in Polycystic Ovarian (PCO) Women in ART.
Polycystic ovarian syndrome population is an androgenic syndrome characterised 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 luteinising-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. Ovid[t]rel[le]®, active ingredient human chorionic-gonadotropin
alfa, is administered to trigger final follicular maturation and luteinisation after
stimulation of follicular growth.
OBJECTIVES
Primary objective:
- To compare the hormonal level changes of plasmatic oestradiol on the releasing day
[day of Rh-family, C glycoprotein (r-hCG) administration] induced by Cetrotide 0.25
mg/day started on Day 1 (Goup A: D1) or on Day 7 (Goup B: D7) of the menstrual cycle
(Day 0 (S0) or Day 6 (S6) of stimulation) in PCO subjects undergoing IVF/ICSI
procedures.
Secondary objectives:
- To compare the hormonal changes during the stimulation induced by Cetrotide in A and B
Groups
- To assess by ultrasound scans (US) the follicular development induced by Cetrotide in A
and B Groups
- To assess biological and clinical outcomes induced by Cetrotide in A and B Groups.
- To monitor safety of Cetrotide in A and B Groups The trial will be conducted on an
outpatient basis. Once each subject has met all eligibility criteria, they will be
randomly assigned in one of the two treatment groups.
Inclusion Criteria:
- Female subjects with PCO or 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) 32, non smoking at least from visit 0 (V0)
- Normal FSH value (< 10 IU/L) on Day 3 of spontaneous cycle within 12 months prior to
the trial
- Anti Mullerian Hormone (AMH) value (> 1.5 ng/ml) of a spontaneous cycle within 12
months prior to the trial or at least at visit 0 (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 V1
- Subject who is able to participate in the trial and has provided written, informed
consent.
Exclusion Criteria:
- Ongoing pregnancy, any pregnancy within three months prior to study entry, or any
contraindication to pregnancy or carrying pregnancy to term
- No drilling 3 months prior to visit 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 two 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 tumours and related treatment
- Known case of tumours 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 Ovid[t]rel[le]
- Any active substance abuse or history of drug, medication or alcohol abuse in the
past five years
- Participation in another clinical trial within three months prior to study entry.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Estradiol (E2) level comparison on the releasing day (day of r-hCG administration) in A and B Groups.
Outcome Time Frame:
Inclusion Visit (Visit 0) and everyday from Day 7 to day of r-hCG administration (ie. at least 2 follicles≥ 17mm in group Day 1 and at least 2 follicles ≥ 19 mm in group Day 7)
Safety Issue:
No
Principal Investigator
Dr Etienne VARLAN
Investigator Role:
Study Director
Investigator Affiliation:
Merck Lipha Santé
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
200088-501
NCT ID:
NCT01185704
Start Date:
November 2008
Completion Date:
June 2011
Related Keywords:
- Polycystic Ovary Syndrome
- Cetrorelix acetate; follitropin alfa; human chorionic-gonadotropin alfa; follicular maturation; pregnancy; ovarian stimulation
- Polycystic Ovary Syndrome
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