PERgoveriS In Stratified Treatment for Assisted Reproductive Technique
Status:
Completed
Trial end date:
2012-10-31
Target enrollment:
Participant gender:
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).
Phase:
Phase 3
Details
Lead Sponsor:
Merck KGaA Merck KGaA, Darmstadt, Germany
Collaborators:
LLC Merck, Russia Merck A.E., Greece Merck A/S, Denmark Merck B.V., Netherlands Merck OY, Finland Merck Pharma, K.S., Slovakia Merck Serono GmbH, Germany Merck Serono S.A., Geneva Merck Serono S.A.S, France Merck Serono S.P.A., Italy Merck Services U.K. Ltd, UK Merck SP. Z.O.O., Poland Merck spol. s r.o., Slovakia