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Phase 3 N=202 Randomized Treatment

PERgoveriS In Stratified Treatment for Assisted Reproductive Technique

Assisted Reproductive Techniques · Reproductive Technology, Assisted

Enrolled (actual)
202
Serious AEs
1.0%
Results posted
Feb 2014
Primary outcome: Primary: Total Number of Oocytes Retrieved — 10.9; 9.7 oocytes

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Gonal-f® (Drug); Pergoveris® (Drug); Recombinant human chorionic gonadotropin (r-hCG) (Drug)
Age
Adult · 36+ yrs
Sex
Female
Sponsor
Merck KGaA, Darmstadt, Germany
Primary completion
Oct 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Number of Oocytes Retrieved
10.9; 9.7
SECONDARY
Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)
3292; 3321; 307; 311
SECONDARY
Total Number of Stimulation Treatment Days
10.6; 10.6
SECONDARY
Implantation Rate
13.3; 24.7
SECONDARY
Number of Fetal Sacs With Activity
1.4; 1.2
SECONDARY
Number of Fetal Hearts With Activity
1.4; 1.3
SECONDARY
Clinical Pregnancy Rate
17.5; 31.7; 17.5; 31.7; 18.9; 34.4
SECONDARY
Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment
1; 1; 0; 1
SECONDARY
Biochemical Pregnancies Rate
23; 41
SECONDARY
Number of Participants With Multiple Pregnancies
6; 8
SECONDARY
Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS)
4; 1; 0; 1
SECONDARY
Number of Participants With Treatment-emergent Adverse Events
26; 23
SECONDARY
Systolic and Diastolic Arterial Blood Pressure Assessments
118.9; 121.2; 74.8; 76.8
SECONDARY
Heart Rate Assessments
75.7; 76.5

Summary

This is a multicenter, 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 (r-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 international unit [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) criterion 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 center's standard practice. * Pergoveris®: (vial/powder, 300 IU per day) from stimulation Day 1 and until required r-hCG criterion 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 center'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 center'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 millimeter [mm] and two follicles >=16 mm). After this, a single injection of r-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 fertilization (IVF), embryo transfer (ET) and luteal support will be performed as per center'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).

Eligibility Criteria

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 randomization visit
  • Have early follicular phase (Day 2-4) serum level of basal follicle stimulating hormone (FSH less than or equal to (= = 2 previous ART cycles with a poor response to gonadotrophin stimulation defined as = = 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
  • Other protocol specified inclusion criteria could also apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01297465). 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.

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