Phase 3
N=136
Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
Polycystic Ovarian Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01185704 ↗Enrolled (actual)
136
Serious AEs
4.6%
Results posted
Jul 2013
Primary outcome: Primary: Estradiol (E2) Levels on r-hCG Day — 1668.86; 1672.80 picogram/milliliter (pg/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cetrorelix acetate (Drug); Recombinant Human Choriogonadotropin (r-hCG) (Drug); Recombinant human follicle stimulating hormone (r-hFSH) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estradiol (E2) Levels on r-hCG Day |
1668.86; 1672.80 | — |
| SECONDARY Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels |
4.87; 6.84; 4.98; 6.69 | — |
| SECONDARY Serum Estradiol (E2) Levels |
30.42; 68.79 | — |
| SECONDARY Serum Progesterone (P4) Levels |
0.83; 0.97 | — |
| SECONDARY Anti Mullerian Hormone (AMH) Levels |
6.27; 7.18 | — |
| SECONDARY 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 |
3.55; 2.49 | — |
| SECONDARY Number and Quality of Oocytes Retrieved |
7.48; 8.11; 2.52; 3.72; 0.09; 0.11 | — |
| SECONDARY Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH) |
1462.50; 1221.35 | — |
| SECONDARY Percentage of Fertilized Oocytes Retrieved |
46.22; 46.86 | — |
| SECONDARY Number of Embryos |
3.18; 3.60 | — |
| SECONDARY Number of Blastocysts |
0.26; 0.20 | — |
| SECONDARY Number of Transferred Embryos |
0.95; 1.02 | — |
| SECONDARY Implantation Rate |
36.90; 32.25 | — |
| SECONDARY Percentage of Participants With Clinical Pregnancy |
20; 20 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
11; 18; 2; 4 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01185704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.