CONSORT Randomized Controlled Trial in Assisted Reproductive Technology

NCT00829244 | Completed Phase 4 Results

• 1 other identifier: 28613
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Infertility; Assisted reproductive technology

Outcome Measures

Primary Outcomes (1)

• Number of Oocytes Retrieved Per Participant

  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.

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

Secondary Outcomes (12)

• 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

Study Arms (2)

CONSORT Dosing

EXPERIMENTAL

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

Drug: GONAL f® prefilled pen

Standard Dosing

ACTIVE COMPARATOR

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

Drug: GONAL f® prefilled pen

Interventions

GONAL f® prefilled pen DRUG

GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only

Also known as: Follitropin alfa, Recombinant human follicle stimulating hormone (r-hFSH), GONAL-f® Prefilled Pen

CONSORT Dosing

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Ovarian enlargement or cyst of unknown etiology
• Ovarian, uterine or mammary cancer
• 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,
• Abnormal gynecological bleeding of undetermined origin

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Research Site

Geneva, Switzerland

Location

Related Publications (1)

• Olivennes F, Trew G, Borini A, Broekmans F, Arriagada P, Warne DW, Howles CM. Randomized, controlled, open-label, non-inferiority study of the CONSORT algorithm for individualized dosing of follitropin alfa. Reprod Biomed Online. 2015 Mar;30(3):248-57. doi: 10.1016/j.rbmo.2014.11.013. Epub 2014 Dec 15.

  PMID: 25596910 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa; Glycoprotein Hormones, alpha Subunit

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chorionic Gonadotropin; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone; Gonadotropins, Pituitary; Luteinizing Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Thyrotropin; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Pablo Arriagada, MD

  Merck Serono S.A., Geneva

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 26, 2009
• Study Start: August 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 13, 2014
• Results First Posted: September 7, 2012

Record last verified: 2014-01

Locations

CH (1)