Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovarian Syndrome
Intervention: Cetrorelix acetate (Drug); Cetrorelix acetate (Drug); Recombinant Human Choriogonadotropin (r-hCG) (Drug); Recombinant human follicle stimulating hormone (r-hFSH) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck KGaA Official(s) and/or principal investigator(s): Dr Etienne VARLAN, Study Director, Affiliation: Merck Lipha Santé
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).
Clinical Details
Official title: A Phase IIIb Randomized Open-label Study to Compare the Estradiol Level on the Releasing Day in 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 (IVF/ICSI).
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Estradiol (E2) Levels on r-hCG Day
Secondary outcome: Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) LevelsSerum Estradiol (E2) Levels Serum Progesterone (P4) Levels Anti Mullerian Hormone (AMH) Levels Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day Number and Quality of Oocytes Retrieved Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH) Percentage of Fertilized Oocytes Retrieved Number of Embryos Number of Blastocysts Number of Transferred Embryos Implantation Rate Percentage of Participants With Clinical Pregnancy Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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 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
administered to trigger final follicular maturation and luteinization after stimulation of
follicular growth.
OBJECTIVES
Primary objective:
- To compare the hormonal level of plasmatic estradiol on the releasing day (day of r-hCG
administration) induced by Cetrotide® 0. 25 mg/day started on Day 1 (Group A: Day 1) or
on Day 7 (Group B: Day 7) 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
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.
Locations and Contacts
Research Site, Toulouse, France
Additional Information
Starting date: November 2008
Last updated: January 20, 2014
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