PERgoveriS In Stratified Treatment for Assisted Reproductive Technique

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 For subjects who have withdrawn from treatment (i.e. after starting Pergoveris® or Gonal-f® but before hCG is given) this visit will take place 20-30 days after their first Pergoveris® or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).

Conditions

• Assisted Reproductive Techniques
• Reproductive Technology, Assisted

Interventions

DRUG

Gonal-f®

Gonal-f® (follitropin alfa) 300 International Unit (IU) will be administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5).

DRUG

Pergoveris®

Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 1 follicles \>= 18 mm). The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.

DRUG

Pergoveris®

Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.

DRUG

Recombinant human chorionic gonadotropin (r-hCG)

250 microgram of r-hCG will be administered once subcutaneously on r-hCG day (at least 1 follicles \>= 18 mm).

Sponsors & Collaborators

• Merck Serono S.A., Geneva

  collaborator INDUSTRY

• Merck A/S, Denmark

  collaborator INDUSTRY

• Merck OY, Finland

  collaborator INDUSTRY

• Merck Serono S.A.S, France

  collaborator INDUSTRY

• Merck Serono GmbH, Germany

  collaborator INDUSTRY

• Merck A.E., Greece

  collaborator INDUSTRY

• Merck B.V., Netherlands

  collaborator INDUSTRY

• Merck SP. Z.O.O., Poland

  collaborator INDUSTRY

• Merck Serono S.P.A., Italy

  collaborator INDUSTRY

• Merck Services U.K. Ltd, UK

  collaborator INDUSTRY

• LLC Merck, Russia

  collaborator INDUSTRY

• Merck spol. s r.o., Slovakia

  collaborator INDUSTRY

• Merck Pharma, K.S., Slovakia

  collaborator INDUSTRY

• Merck KGaA, Darmstadt, Germany

  lead INDUSTRY

Principal Investigators

• Salvatore Longobardi, MD · Merck Serono S.P.A., Italy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

36 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2012-10-31

Completion

2012-10-31

Countries

• Denmark
• Finland
• France
• Germany
• Greece
• Italy
• Netherlands
• Poland
• Russia
• Slovakia
• United Kingdom

Study Locations