PERSIST Study (PERgoveriS In Stratified Treatment) for ART
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Purpose
This is a multicentre, multi-national, randomized, open-label comparative trial. After screening, the subjects will start down-regulation treatment on Day 21-22 of the cycle. Down-regulation treatment will start within 2 months following the screening visit. The routine long luteal phase protocol for gonadotropin-releasing hormone (GnRH) agonist treatment will be followed. Once down-regulation has been confirmed, a pregnancy test will be performed just before randomization and start of recombinant human follicle-stimulating hormone (hFSH) treatment to rule out any pre-existing pregnancy. If the result is negative, the subject will be randomly assigned to one of the two treatment arms of the trial:
- GONAL-f: (Liquid Pen; 300 IU of per day) stimulation Day 1-5 followed by Pergoveris (vial/powder, 300 IU per day) from stimulation Day 6 and until required recombinant human chorionic hormone (r-hCG) level is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the centre's standard practice.
- Pergoveris: (vial/powder, 300 IU per day) from stimulation Day 1 and until required r-hCG level is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the centre's standard practice.
Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Follicular development will be monitored according to the centre's standard practice by ultrasound (US) and/or estradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least one follicle greater than or equal to 18 mm and two follicles greater than or equal to 16 mm). After this, a single injection of hCG will be administered in order to induce final oocyte maturation.
At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-5 days after oocyte recovery . Ovum pick up (OPU), in vitro fertilisation (IVF), embryo transfer (ET) and luteal support will be performed as per centre's standard practice.
A post-treatment safety visit will be performed for all subjects who received r-hCG (pregnant and non- pregnant) on Day 15-20 post-hCG . For subjects who have withdrawn from treatment (i.e. after starting Pergoveris or GONAL-f but before hCG is given) this visit will take place 20-30 days after their first Pergoveris® or GONAL-f treatment injection (excluding pregnancy testing).
| Condition | Intervention | Phase |
|---|---|---|
|
Assisted Reproductive Techniques Reproductive Technology, Assisted |
Drug: Gonal-f + Pergoveris Drug: Pergoveris |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase IIIB, Multicentre, Multinational, Randomized, Open-label Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® Day 1 to Day 5 Followed by Pergoveris® Starting Day 6 to Pergoveris® Starting Day 1 in Women Between 36 and 40 Years of Age Undergoing Assisted Reproductive Technique (ART) |
- Total number of oocytes retrieved per subject following ovarian stimulation. [ Time Frame: At 34-38 hours post r-hCG administration ] [ Designated as safety issue: No ]
- Total dose of FSH used (in IU) [ Time Frame: After completion of stimulation (Day 1 to Day [Sn] ] [ Designated as safety issue: No ]
- Total number of stimulation treatment days [ Time Frame: After completion of stimulation (Day 1 to Day [Sn]) ] [ Designated as safety issue: No ]
- Implantation rate (fetal sacs per total number of embryos transferred) [ Time Frame: Days 35-42 post hCG ] [ Designated as safety issue: No ]
- Number of foetal sacs and foetal hearts with activity as seen on an US scan on Day 35-42 post hCG (to confirm clinical pregnancy) [ Time Frame: Days 35-42 post hCG ] [ Designated as safety issue: No ]
- Total and clinical pregnancy rate per subject (per cycle started, and per embryo transfer [ET]) [ Time Frame: Days 35-42 post hCG ] [ Designated as safety issue: No ]
- Cycle cancellation prior to hCG [ Time Frame: During Stimulation Days ] [ Designated as safety issue: No ]
- Number of biochemical pregnancies (by serum beta- hCG level) [ Time Frame: Days 35-42 post hCG ] [ Designated as safety issue: No ]
- Multiple pregnancy [ Time Frame: Days 35-42 post hCG ] [ Designated as safety issue: No ]
- Occurrence of any adverse events (early and late ovarian hyperstimulation syndrome (OHSS) [ Time Frame: Days 15-20 post hCG ] [ Designated as safety issue: Yes ]
- Adverse events that are treatment-emergent, in accordance with the Pergoveris investigator brochure. [ Time Frame: Days 15-20 post hCG ] [ Designated as safety issue: Yes ]
- Vital signs mainly systemic arterial blood pressure (systolic and diastolic), and heart rate. [ Time Frame: Days 15-20 post hCG ] [ Designated as safety issue: Yes ]
| Enrollment: | 208 |
| Study Start Date: | May 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Gonal f + Pergoveris |
Drug: Gonal-f + Pergoveris
GONAL-f: (Liquid Pen; 300 IU of per day) stimulation Day 1-5 followed by Pergoveris (vial/powder, 300 IU per day) from stimulation Day 6 and until required r-hCG level is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the centre's standard practice. The GONAL-f prefilled pen will be provided in dose presentations of 450 IU and 900 IU. The prefilled pen allows the accurate delivery of a precise dose of GONAL-f in 37.5 IU increments. |
| Experimental: Pergoveris |
Drug: Pergoveris
Pergoveris: (vial/powder, 300 IU per day) from stimulation Day 1 and until required r-hCG level is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the centre's standard practice. Pergoveris is provided as a freeze- dried formulation (vial containing 150 IU of r-hFSH and 75 IU of r-hLH, to be reconstituted with solution for subcutaneous injection). |
Eligibility| Ages Eligible for Study: | 36 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be a female subject justifying an in vitro fertilization and embryo transfer (IVF/ET) treatment
- Be between her 36th and 40th birthday (both included) at the time of the randomisation visit
- Have early follicular phase (Day 2-4) serum level of basal follicle stimulating hormone (FSH ≤12 IU/L) measured in the centre's local laboratory during the screening period (i.e. within 2 months prior to down-regulation start)
- A body mass index (BMI) < 30 kg/m2
- Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length
- Be willing and able to comply with the protocol for the duration of the trial
- Have given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care
- Have a male partner with semen analysis within the past 6 months prior to randomisation considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the centre's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used
Exclusion Criteria:
- Had greater than or equal to 2 previous ART cycles with a poor response to gonadotrophin stimulation defined as ≤6 mature follicles and/or ≤4 oocytes collected in any previous IVF cycle or previous cycles with a hyper response defined as greater than or equal to 25 oocytes retrieved
- Any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's medical responsible
- Had previous severe ovarian Hyperstimulation Syndrome (OHSS)
- Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS
- Any contraindication to being pregnant and/or carrying a pregnancy to term
- History of 3 or more miscarriages (early or late miscarriages) due to any cause
- A clinically significant systemic disease
- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner
- Known allergy or hypersensitivity to human gonadotrophin preparations
- Entered previously into this trial or simultaneous participation in another clinical trial.
- Pregnancy and lactation period
- Participation in another clinical trial within the past 30 days
Contacts and Locations| Germany | |
| Merck Serono Research Site | |
| Halle, Germany | |
| Study Director: | Salvatore Longobardi, MD | Merck Serono S.P.A., Italy |
More Information
No publications provided
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01297465 History of Changes |
| Other Study ID Numbers: | EMR 200061-504, 2010-023534-23 |
| Study First Received: | February 15, 2011 |
| Last Updated: | October 1, 2012 |
| Health Authority: | Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Italy: The Italian Medicines Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Slovakia: State Institute for Drug Control United Kingdom: Medicines and Healthcare Products Regulatory Agency Russia: Ministry of Health of the Russian Federation |
Keywords provided by Merck KGaA:
|
Ovulation Induction Ovarian Stimulation Reproductive Technique, Assisted |
Assisted Reproductive Technics Assisted Reproductive Technique Reproductive Technology, Assisted |
ClinicalTrials.gov processed this record on May 16, 2013