Clinical trial · Interventional
Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
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).
NCT01185704CI-TRIAL-00013753ATTAC-PCOcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetrorelix acetate | Drug | — | UNRESOLVED |
| Recombinant Human Choriogonadotropin (r-hCG) | Drug | — | UNRESOLVED |
| Recombinant human follicle stimulating hormone (r-hFSH) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Day 1 protocol
- interventionNames
- Drug: Cetrorelix acetate
- Drug: Recombinant Human Choriogonadotropin (r-hCG)
- Drug: Recombinant human follicle stimulating hormone (r-hFSH)
- type
- EXPERIMENTAL
- label
- Day 7 protocol
- interventionNames
- Drug: Cetrorelix acetate
- Drug: Recombinant Human Choriogonadotropin (r-hCG)
- Drug: Recombinant human follicle stimulating hormone (r-hFSH)
Primary outcomes (1)
- measure
- Estradiol (E2) Levels on r-hCG Day
- timeFrame
- r-hCG day (end of stimulation cycle [approximately 15 days])
Secondary outcomes (14)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.