NCT01185704

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 0.25 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 3, 2013

Completed
Last Updated

February 13, 2014

Status Verified

January 1, 2014

Enrollment Period

2.9 years

First QC Date

August 10, 2010

Results QC Date

March 25, 2013

Last Update Submit

January 20, 2014

Conditions

Polycystic Ovarian Syndrome

Keywords

Cetrorelix acetate; follitropin alfa; human chorionic-gonadotropin alfa; follicular maturation; pregnancy; ovarian stimulation

Outcome Measures

Primary Outcomes (1)

  • Estradiol (E2) Levels on r-hCG Day

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

Secondary Outcomes (14)

  • Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels

    Day 1

  • Serum Estradiol (E2) Levels

    Day 1

  • Serum Progesterone (P4) Levels

    Day 1

  • Anti Mullerian Hormone (AMH) Levels

    Day 0

  • 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

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

  • +9 more secondary outcomes

Study Arms (2)

Day 1 protocol

EXPERIMENTAL
Drug: Cetrorelix acetateDrug: Recombinant Human Choriogonadotropin (r-hCG)Drug: Recombinant human follicle stimulating hormone (r-hFSH)

Day 7 protocol

EXPERIMENTAL
Drug: Cetrorelix acetateDrug: Recombinant Human Choriogonadotropin (r-hCG)Drug: Recombinant human follicle stimulating hormone (r-hFSH)

Interventions

Cetrorelix acetateDRUG

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)

Also known as: Cetrotide®
Day 1 protocol
Recombinant Human Choriogonadotropin (r-hCG)DRUG

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

Also known as: Ovitrelle®
Day 1 protocolDay 7 protocol
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

Day 1 protocolDay 7 protocol

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Toulouse, France

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

cetrorelixChorionic GonadotropinGlycoprotein Hormones, alpha Subunit

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteinsFollicle Stimulating HormoneGonadotropins, PituitaryLuteinizing HormonePituitary Hormones, AnteriorPituitary HormonesThyrotropin

Results Point of Contact

Title
Merck KGaA Communication Center
Organization
Merck Serono, a division of Merck KGaA
service@merckgroup.com
+49-6151-72-5200

Study Officials

  • Dr Etienne VARLAN

    Merck Lipha Santé

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2010

First Posted

August 20, 2010

Study Start

November 1, 2008

Primary Completion

October 1, 2011

Study Completion

February 1, 2012

Last Updated

February 13, 2014

Results First Posted

July 3, 2013

Record last verified: 2014-01

Locations

FR(1)