Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)

NCT00249834 | Completed Phase 4 Results

• 1 other identifier: 25198
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.

Conditions

Infertility

Keywords

Assisted Reproductive Technology (ART); Infertility; Ovarian stimulation

Outcome Measures

Primary Outcomes (1)

• Number of Oocytes Retrieved

  Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.

  Ovum pick up day (34 to 38 hours post r-hCG administration)

Secondary Outcomes (7)

• Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)

  up to end of stimulation cycle (approximately 31 days)

• Mean Number of Ovarian Stimulation Days

  up to end of stimulation cycle (approximately 31 days)

• Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH

  up to end of stimulation cycle (approximately 31 days)

• Number of Subjects Needing Dose Adjustment

  6 days post r-hFSH treatment

• Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose

  up to end of stimulation cycle (approximately 31 days)

Study Arms (8)

Gonal-f 112.5 IU

EXPERIMENTAL

Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG)

Gonal-f 37.5 IU

EXPERIMENTAL

Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG)

Gonal-f 75 IU

EXPERIMENTAL

Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG)

Gonal-f 150 IU

EXPERIMENTAL

Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG)

Gonal-f 187.5 IU

EXPERIMENTAL

Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG)

Gonal-f 225 IU

EXPERIMENTAL

Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG)

Gonal-f 262.5 IU

EXPERIMENTAL

Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG)

Gonal-f 300 IU

EXPERIMENTAL

Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG)

Interventions

Gonal-f DRUG

GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.

Also known as: follitropin alfa, Recombinant Human Follicle Stimulating Hormone (r-hFSH)

Gonal-f 112.5 IU; Gonal-f 150 IU; Gonal-f 187.5 IU; Gonal-f 225 IU; Gonal-f 262.5 IU; Gonal-f 300 IU; Gonal-f 37.5 IU; Gonal-f 75 IU

Recombinant human chorionic gonadotrophin (r-hCG) DRUG

When at least 1 follicle greater than or equal to (\>=) 18 millimeter (mm) and 2 follicles \>=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.

Gonal-f 112.5 IU; Gonal-f 150 IU; Gonal-f 187.5 IU; Gonal-f 225 IU; Gonal-f 262.5 IU; Gonal-f 300 IU; Gonal-f 37.5 IU; Gonal-f 75 IU

Eligibility Criteria

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

You may qualify if:

• Be an infertile subject justifying an in-vitro fertilization/embryo transfer (IVF/ET) treatment.
• Have a male partner with semen analysis within the past six months prior to study entry 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.
• Be between her 18th and 35th birthday (35 not included).
• Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length.
• Have early follicular phase (Day 2-4) serum levels within the last 3 months prior to study entry of:
• Follicle stimulating hormone (FSH) greater than or equal to (\>=) 12 International units per liter (IU/L), and
• Oestradiol (E2) within center's local normal laboratory range values.
• Presence of both ovaries.
• Have a uterine cavity without abnormalities, which, in the investigator's opinion, could impair embryo implantation or pregnancy evolution as assessed within the last 3 years using ultrasound (US), hysteroscopy (HSC), or hysterosalpingography (HSG).
• Have a negative cervical papanicolaou (PAP) test within the last 6 months prior to study entry.
• Have at least one wash-out cycle (defined as \>= 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 gonadotrophin releasing hormone (GnRH) agonist therapy.
• Have a negative pregnancy test prior to beginning GnRH agonist therapy.
• Be willing and able to comply with the protocol for the duration of the study. Have given written informed consent, prior to any study-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:

• Had 2 previous ART cycles with a poor response to gonadotrophin stimulation, defined as less than or equal to (\<=) 5 mature follicles and/or \<=3 oocytes collected in any previous IVF cycle or hyper response, defined as \>=25 oocytes retrieved.
• Any medical condition, which in the judgement 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 Serono's Therapeutic Director.
• Had previous severe ovarian hyperstimulation syndrome (OHSS).
• A body mass index (BMI) greater than (\>) 30 kilogram per square meter (kg/m\^2)
• Any contraindication to being pregnant and/or carrying a pregnancy to term.
• Extra-uterine pregnancy within the last 3 months.
• History of 3 or more miscarriages (early or late miscarriages) due to any cause.
• Tumours of the hypothalamus and pituitary gland.
• Ovarian enlargement or cyst of unknown aetiology.
• Ovarian, uterine or mammary cancer.
• A clinically significant systemic disease.
• Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus.
• Abnormal gynaecological bleeding of undetermined origin.
• Known allergy or hypersensitivity to human gonadotrophin preparations.
• Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years.

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Medical Information

Paris, France

Location

Related Publications (2)

• Olivennes F, Howles CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V; CONSORT study group. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2009 Feb;18(2):195-204. doi: 10.1016/s1472-6483(10)60256-8.

  PMID: 19192339 BACKGROUND

• Olivennes F, Howies CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2011 Feb;22 Suppl 1:S73-82. doi: 10.1016/S1472-6483(11)60012-6.

  PMID: 21575853 RESULT

Related Links

• Full FDA approved prescribing information can be found here

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa; Glycoprotein Hormones, alpha Subunit; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

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; Pregnancy Proteins; Proteins

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: November 4, 2005
• First Posted: November 7, 2005
• Study Start: September 22, 2004
• Primary Completion: January 16, 2006
• Study Completion: January 16, 2006
• Last Updated: March 30, 2018
• Results First Posted: March 30, 2018

Record last verified: 2017-08

Locations

FR (1)