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

NCT ID: NCT00249834

Last Updated: 2018-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-22
• Study Completion Date: 2006-01-16

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gonal-f 112.5 IU

Group Type: EXPERIMENTAL

Gonal-f

Intervention Type: 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.

Recombinant human chorionic gonadotrophin (r-hCG)

Intervention Type: 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 37.5 IU

Group Type: EXPERIMENTAL

Gonal-f

Intervention Type: 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.

Recombinant human chorionic gonadotrophin (r-hCG)

Intervention Type: 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 75 IU

Group Type: EXPERIMENTAL

Gonal-f

Intervention Type: 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.

Recombinant human chorionic gonadotrophin (r-hCG)

Intervention Type: 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 150 IU

Group Type: EXPERIMENTAL

Gonal-f

Intervention Type: 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.

Recombinant human chorionic gonadotrophin (r-hCG)

Intervention Type: 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 187.5 IU

Group Type: EXPERIMENTAL

Gonal-f

Intervention Type: 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.

Recombinant human chorionic gonadotrophin (r-hCG)

Intervention Type: 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 225 IU

Group Type: EXPERIMENTAL

Gonal-f

Intervention Type: 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.

Recombinant human chorionic gonadotrophin (r-hCG)

Intervention Type: 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 262.5 IU

Group Type: EXPERIMENTAL

Gonal-f

Intervention Type: 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.

Recombinant human chorionic gonadotrophin (r-hCG)

Intervention Type: 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 300 IU

Group Type: EXPERIMENTAL

Gonal-f

Intervention Type: 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.

Recombinant human chorionic gonadotrophin (r-hCG)

Intervention Type: 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.

Interventions

Gonal-f

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.

Intervention Type: DRUG

Recombinant human chorionic gonadotrophin (r-hCG)

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.

Intervention Type: DRUG

Other Intervention Names

follitropin alfa; Recombinant Human Follicle Stimulating Hormone (r-hFSH)

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Entered previously into this study or simultaneous participation in another clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

Locations

Medical Information

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 19192339 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21575853 (View on PubMed)

Related Links

http://www.fertilitylifelines.com

Full FDA approved prescribing information can be found here

Other Identifiers

25198

Identifier Type: -

Identifier Source: org_study_id