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

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 3

Conditions

Polycystic Ovarian Syndrome

Treatments

Drug: Recombinant Human Choriogonadotropin (r-hCG)

Drug: Cetrorelix acetate

Drug: Recombinant human follicle stimulating hormone (r-hFSH)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01185704

INI 28091 (Other Identifier)

2007-007932-25 (EudraCT Number)

EMR200088-501

Details and patient eligibility

About

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).

Full 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.

Enrollment

136 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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.