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Polycystic Ovarian SyndromePhase 3ATTAC-PCONCT01185704

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

A Phase 3 study testing Cetrorelix acetate, Recombinant Human Choriogonadotropin (r-hCG) and Recombinant human follicle stimulating hormone (r-hFSH) in people with Polycystic Ovarian Syndrome, run by Merck KGaA, Darmstadt, Germany at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Polycystic Ovarian Syndrome
What is being tested?
Cetrorelix acetate, Recombinant Human Choriogonadotropin (r-hCG) and Recombinant human follicle stimulating hormone (r-hFSH)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteFrance
Study dates
Nov 2008to Feb 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Research Site

    Toulouse

Other trials in France

About this study

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).

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).

Read the 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.

Being tested
Cetrorelix acetate, Recombinant Human Choriogonadotropin (r-hCG), Recombinant human follicle stimulating hormone (r-hFSH)
Keywords
Cetrorelix acetate; follitropin alfa; human chorionic-gonadotropin alfa; follicular maturation; pregnancy; ovarian stimulation
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cetrorelix acetateDrug

    Also called Cetrotide®

    Cetrotide® 0.25 mg will be administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) until r-hCG day (at least 2 follicles >=17 mm)

  • Cetrorelix acetateDrug

    Also called Cetrotide®

    Cetrotide® 0.25 mg will be administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) until r-hCG day (at least 2 follicles >=19 mm)

  • Recombinant Human Choriogonadotropin (r-hCG)Drug

    Also called Ovitrelle®

    The r-hCG will be administered subcutaneously as a single dose of 250 microgram (mcg) on r-hCG day

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

    Recombinant human follicle stimulating hormone (r-hFSH) will be administered subcutaneously at a dose between 75 and 187.5 international unit (IU) once daily from Day 2 (Day 1 of stimulation period [S1]) until r-hCG day

Study groups in NCT01185704
Study groupRoleWhat they receive
Day 1 protocolExperimentalNot described
Receives: Drug: Cetrorelix acetate; Drug: Recombinant Human Choriogonadotropin (r-hCG); Drug: Recombinant human follicle stimulating hormone (r-hFSH)
Day 7 protocolExperimentalNot described
Receives: Drug: Cetrorelix acetate; Drug: Recombinant Human Choriogonadotropin (r-hCG); Drug: Recombinant human follicle stimulating hormone (r-hFSH)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estradiol (E2) Levels on r-hCG Day

    Measured: r-hCG day (end of stimulation cycle [approximately 15 days])

Secondary outcomes (14)

  1. Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels

    Measured: Day 1

  2. Serum Estradiol (E2) Levels

    Measured: Day 1

  3. Serum Progesterone (P4) Levels

    Measured: Day 1

  4. Anti Mullerian Hormone (AMH) Levels

    Measured: Day 0

  5. 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

    Measured: r-hCG day (end of stimulation cycle [approximately 15 days])

  6. Number and Quality of Oocytes Retrieved

    Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. Oocytes were classified into 4 different categories based on their quality: mature, fractured, immature and inseminated oocytes.

    Measured: Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

  7. Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)

    Measured: Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])

  8. Percentage of Fertilized Oocytes Retrieved

    Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an IVF procedure in which a single sperm is injected directly into an egg under a microscope.

    Measured: Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

  9. Number of Embryos

    Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes.

    Measured: Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

  10. Number of Blastocysts

    Blastocyst is an embryo, five or six days after fertilization, with an inner cell mass, outer layer of trophectoderm and a fluid-filled blastocoele cavity.

    Measured: Day 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

  11. Number of Transferred Embryos

    Embryo transfer is the procedure in which one or more embryos are placed in the uterus.

    Measured: Day 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

  12. Implantation Rate

    Implantation rate per reporting group was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.

    Measured: 5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

  13. Percentage of Participants With Clinical Pregnancy

    Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.

    Measured: 10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days])

  14. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. To avoid the participant/event combination double-count AEs and SAEs are reported separately.

    Measured: Day 1 up to end of study (15 days post last administration of study drug)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2010 (estimated)
  2. Study startNov 2008
  3. Primary completionOct 2011
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01185704
Sponsor's protocol ID
EMR200088-501
Other IDs
2007-007932-25, INI 28091
Acronym
ATTAC-PCO
Status last verified
Jan 2014
First submitted
10 Aug 2010
Last updated
13 Feb 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cetrorelix acetate, Recombinant Human Choriogonadotropin (r-hCG) and Recombinant human follicle stimulating hormone (r-hFSH) in people with Polycystic Ovarian Syndrome, run by Merck KGaA, Darmstadt, Germany at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estradiol (E2) Levels on r-hCG Day (time frame: r-hCG day (end of stimulation cycle [approximately 15 days])). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01185704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2014.

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