Primary outcomeMean· r-hCG day (end of stimulation cycle [approximately 15 days])
Estradiol (E2) Levels on r-hCG Day
| Group | Value (picogram/milliliter (pg/mL)) | Spread |
|---|---|---|
| Day 1 Protocol | 1668.86 | 862.62 |
| Day 7 Protocol | 1672.80 | 835.49 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataAnalysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
Short name ATTAC-PCO
NCTNCT01185704 (opens ClinicalTrials.gov in a new tab)Other idEMR200088-501Other id2007-007932-25Other idINI 28091
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 136 participants (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
France
- Start
- Nov 2008
- Primary completion
- Oct 2011
- Completion
- Feb 2012
- First posted
- 20 Aug 2010 (estimated)
- Last update posted
- 13 Feb 2014 (estimated)
- Conditions
- Polycystic Ovarian Syndrome
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200820092010201120122013
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown 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).
Interventions
- Cetrorelix acetateDrug
- Cetrorelix acetateDrug
- Recombinant Human Choriogonadotropin (r-hCG)Drug
- Recombinant human follicle stimulating hormone (r-hFSH)Drug
Arms2
Experimental
Day 1 protocol
Experimental
Day 7 protocol
Primary outcomes1
Outcomes the sponsor listed as primary.
Estradiol (E2) Levels on r-hCG Day
Time frame · r-hCG day (end of stimulation cycle [approximately 15 days])
Secondary outcomes(14)
Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels
Time frame · Day 1
Serum Estradiol (E2) Levels
Time frame · Day 1
Serum Progesterone (P4) Levels
Time frame · Day 1
Anti Mullerian Hormone (AMH) Levels
Time frame · 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
Time frame · r-hCG day (end of stimulation cycle [approximately 15 days])
Number and Quality of Oocytes Retrieved
Time frame · Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Registry description
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.
Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)
Time frame · Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])
Percentage of Fertilized Oocytes Retrieved
Time frame · Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Registry description
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.
Number of Embryos
Time frame · Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Registry description
Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes.
Number of Blastocysts
Time frame · Day 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Registry description
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.
Number of Transferred Embryos
Time frame · Day 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Registry description
Embryo transfer is the procedure in which one or more embryos are placed in the uterus.
Implantation Rate
Time frame · 5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Registry description
Implantation rate per reporting group was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.
Percentage of Participants With Clinical Pregnancy
Time frame · 10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days])
Registry description
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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame · Day 1 up to end of study (15 days post last administration of study drug)
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Day 1
Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels
| Group | Value (International unit/liter (IU/L)) | Spread |
|---|---|---|
| Day 1 Protocol | 4.87 | 4.62 |
| Day 7 Protocol | 6.84 | 3.99 |
Secondary outcomeMean· Day 1
Serum Estradiol (E2) Levels
| Group | Value (pg/mL) | Spread |
|---|---|---|
| Day 1 Protocol | 30.42 | 14.06 |
| Day 7 Protocol | 68.79 | 116.09 |
Secondary outcomeMean· Day 1
Serum Progesterone (P4) Levels
| Group | Value (nanomolar/liter (nmol/L)) | Spread |
|---|---|---|
| Day 1 Protocol | 0.83 | 0.72 |
| Day 7 Protocol | 0.97 | 1.82 |
Secondary outcomeMean· Day 0
Anti Mullerian Hormone (AMH) Levels
| Group | Value (nanogram/milliliter (ng/mL)) | Spread |
|---|---|---|
| Day 1 Protocol | 6.27 | 4.40 |
| Day 7 Protocol | 7.18 | 4.11 |
Secondary outcomeMean· r-hCG day (end of stimulation cycle [approximately 15 days])
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
| Group | Value (follicles) | Spread |
|---|---|---|
| Day 1 Protocol | 3.55 | 2.20 |
| Day 7 Protocol | 2.49 | 1.99 |
Secondary outcomeMean· Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Number and Quality of Oocytes Retrieved
| Group | Value (oocytes) | Spread |
|---|---|---|
| Day 1 Protocol | 7.48 | 5.21 |
| Day 7 Protocol | 8.11 | 5.55 |
Secondary outcomeMean· Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])
Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)
| Group | Value (international unit (IU)) | Spread |
|---|---|---|
| Day 1 Protocol | 1462.50 | 537.85 |
| Day 7 Protocol | 1221.35 | 478.31 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Day 1 ProtocolCetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. | – | 2 / 65 | 9 / 65 |
| Day 7 ProtocolCetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. | – | 4 / 65 | 14 / 65 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 35 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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