A Phase IV Prospective, Multicenter, Randomized, Open-label Trial to Assess the Efficacy and Safety of GONAL f® at a Dose Based on Subject Baseline Characteristics Determined According to the CONSORT Calculator Compared With a Standard Dose of GONAL f® 150 IU Per Day for Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology (ART)

Merck KGaA, Darmstadt, Germany1 site in 1 country200 target enrollmentAugust 2008

ConditionsInfertility

InterventionsGONAL f® prefilled pen

DrugsGONAL f® prefilled pen

Overview

Phase: Phase 4
Intervention: GONAL f® prefilled pen
Conditions: Infertility
Sponsor: Merck KGaA, Darmstadt, Germany
Enrollment: 200
Locations: 1
Primary Endpoint: Number of Oocytes Retrieved Per Participant
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The overall objective of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment' (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per day.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

January 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Merck KGaA, Darmstadt, Germany

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female subjects justifying an in-vitro fertilization (IVF)/embryo transfer (ET) treatment
•Have a male partner with semen analysis within the past 6 months prior to randomization considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used
•Between her 18th and 35th birthday (35 not included) at the time of the randomization visit
•Body mass index (BMI) lower than 30 kilogram per square meter (kg/m\^2) where the BMI is calculated according to the formula
•Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length
•Have an early follicular phase (Day 2-4) serum level of basal FSH lower than or equal to 12 International Unit per Liter (IU/L) measured in the center's local laboratory during the screening period (i.e. within 2 months prior to down-regulation start)
•Presence of both ovaries
•Normal uterine cavity, which in the investigator's opinion is compatible with pregnancy
•Have a negative cervical papanicolaou (PAP) test within the last 6 months prior to randomization
•Have at least 1 wash-out cycle (defined as greater than or equal to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotropin releasing hormone (GnRH) agonist therapy

Exclusion Criteria

•Have greater than or equal to 2 previous ART cycles with a poor response to gonadotrophin stimulation (defined as lower than or equal to 5 mature follicles and/or lower than or equal to 3 oocytes collected) or have greater than or equal to 2 previous ART 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
•Have previous severe ovarian hyperstimulation syndrome (OHSS)
•Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS
•Presence of endometriosis requiring treatment
•Uterine myoma requiring treatment
•Any contraindication to being pregnant and/or carrying a pregnancy to term
•Extra-uterine pregnancy within the last 3 months prior to screening
•History of 3 or more miscarriages (early or late miscarriages) due to any cause
•Tumors of the hypothalamus and pituitary gland

Arms & Interventions

CONSORT Dosing

GONAL-f® dose based on subject baseline characteristics determined according to the CONSORT calculator

Intervention: GONAL f® prefilled pen

Standard Dosing

GONAL-f® at a standard dose of 150 IU per day

Intervention: GONAL f® prefilled pen

Outcomes

Primary Outcomes

Number of Oocytes Retrieved Per Participant

Time Frame: 34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU)

Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.

Secondary Outcomes

Total GONAL-f® Dose(Start of treatment until end of stimulation cycle (approximately 28 days))
Mean GONAL-f® Daily Dose(Start of treatment until end of stimulation cycle (approximately 28 days))
Total Number of GONAL-f® Stimulation Treatment Days(Start of treatment until end of stimulation cycle (approximately 28 days))
Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment(Start of treatment until Day 15-20 post-hCG)
Percentage of Participants With Biochemical Pregnancies(Start of treatment until Day 15-20 Post-hCG)
Number of Participants With Fetal Sacs and Fetal Hearts(Day 35-42 Post-hCG)
Implantation Rate(Day 35-42 Post-hCG)
Number of Participants With Multiple Pregnancies(Day 35-42 Post-hCG)
Serum Progesterone (P4) Levels(End of stimulation cycle (approximately 28 days))
Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome(up to 9 month (following the end of treatment))
Percentage of Participants With Clinical Pregnancy(Day 35-42 Post-hCG)
Number of Participants With OHSS(Start of treatment until Day 15-20 Post-hCG)