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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Short name CONSORT

Overview

Status
Completed
Phase
Phase 4
Enrollment
166 participants (actual)
Sponsor
Merck KGaA, Darmstadt, Germany · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

France

Start
22 Sept 2004
Primary completion
16 Jan 2006
Completion
16 Jan 2006
First posted
7 Nov 2005 (estimated)
Last update posted
30 Mar 2018
Conditions
Infertility

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2004200520062007
  1. Ph 4

    CONSORT

    NCT00249834

    22 Sept 2004 to 16 Jan 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Gonal-fDrug
  • Recombinant human chorionic gonadotrophin (r-hCG)Drug

Arms8

  • Experimental

    Gonal-f 112.5 IU

  • Experimental

    Gonal-f 37.5 IU

  • Experimental

    Gonal-f 75 IU

  • Experimental

    Gonal-f 150 IU

  • Experimental

    Gonal-f 187.5 IU

  • Experimental

    Gonal-f 225 IU

  • Experimental

    Gonal-f 262.5 IU

  • Experimental

    Gonal-f 300 IU

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Oocytes Retrieved

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

    Registry description

    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.

Secondary outcomes(7)
  1. Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)

    Time frame · up to end of stimulation cycle (approximately 31 days)

    Registry description

    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.

  2. Mean Number of Ovarian Stimulation Days

    Time frame · up to end of stimulation cycle (approximately 31 days)

    Registry description

    The mean number of stimulation days were determined based on the treatment administration information collected in the case report form. Ovarian stimulation included time from first r-hFSH injection (stimulation Day) until day on which r-hCG was administered (r-hCG day). 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.

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

    Time frame · up to end of stimulation cycle (approximately 31 days)

    Registry description

    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.

  4. Number of Subjects Needing Dose Adjustment

    Time frame · 6 days post r-hFSH treatment

    Registry description

    Number of subjects needing increase in dose, decrease in dose or increase and decrease both in dose were reported. 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.

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

    Time frame · up to end of stimulation cycle (approximately 31 days)

    Registry description

    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.

  6. Embryo Implantation Rate

    Time frame · 35-42 days post r-hCG administration

    Registry description

    Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. 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.

  7. Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate

    Time frame · 35-42 days post r-hCG administration

    Registry description

    Overall pregnancy rate was defined as the percentage of subjects with serum beta-hCG levels greater than 10 IU/L. Clinical pregnancy rate was defined as the percentage of subjects with at least 1 ultrasound confirmed gestational sac, with or without foetal heart activity. Multiple pregnancy rate was defined as the percentage of subjects with more than 1 ultrasound confirmed gestational sac in the uterus with fetal heart activity. 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Number of Oocytes Retrieved

GroupValue (Oocytes)Spread
Gonal-f 75 IU8.34.5
Gonal-f 112.5 IU9.66.5
Gonal-f 150 IU12.16.4
Gonal-f 187.5 IU12.74.3
Gonal-f 225 IU8.33.8
Secondary and other outcome results(7)
Secondary outcomeMean· up to end of stimulation cycle (approximately 31 days)

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

GroupValue (International Units (IU))Spread
Gonal-f 75 IU1102.3671.8
Gonal-f 112.5 IU1287.2447.0
Gonal-f 150 IU1632.4341.5
Gonal-f 187.5 IU2043.8276.2
Gonal-f 225 IU2572.5552.3
Secondary outcomeMean· up to end of stimulation cycle (approximately 31 days)

Mean Number of Ovarian Stimulation Days

GroupValue (Days)Spread
Gonal-f 75 IU12.54.4
Gonal-f 112.5 IU11.02.9
Gonal-f 150 IU10.61.8
Gonal-f 187.5 IU11.01.4
Gonal-f 225 IU11.52.4
Secondary outcomeNumber· up to end of stimulation cycle (approximately 31 days)

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

GroupValue (Percentage of cycles)
Gonal-f 75 IU0.0
Gonal-f 112.5 IU0.0
Gonal-f 150 IU2.9
Gonal-f 187.5 IU0.0
Gonal-f 225 IU0.0
Secondary outcomeNumber· 6 days post r-hFSH treatment

Number of Subjects Needing Dose Adjustment

GroupValue (subjects)
Gonal-f 75 IU7
Gonal-f 112.5 IU3
Gonal-f 150 IU3
Gonal-f 187.5 IU1
Gonal-f 225 IU0
Secondary outcomeMean· up to end of stimulation cycle (approximately 31 days)

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

GroupValue (IU/day)Spread
Gonal-f 75 IU84.421.6
Gonal-f 112.5 IU114.716.4
Gonal-f 150 IU153.612.8
Gonal-f 187.5 IU186.55.8
Gonal-f 225 IU223.35.3
Secondary outcomeMean· 35-42 days post r-hCG administration

Embryo Implantation Rate

GroupValue (Percent sacs per embryo)Spread
Gonal-f 75 IU36.542.8
Gonal-f 112.5 IU24.335.0
Gonal-f 150 IU28.238.9
Gonal-f 187.5 IU37.140.5
Gonal-f 225 IU11.920.9
Secondary outcomeNumber· 35-42 days post r-hCG administration

Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate

GroupValue (Percentage of subjects)
Gonal-f 75 IU17
Gonal-f 112.5 IU18
Gonal-f 150 IU16
Gonal-f 187.5 IU16
Gonal-f 225 IU2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Gonal-f 75 IUGONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day 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. When at least 1 follicle \>=18 mm and 2 follicles \>=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.–3 / 4811 / 48
Gonal-f 112.5 IUGONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day 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. When at least 1 follicle \>=18 mm and 2 follicles \>=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.–3 / 4515 / 45
Gonal-f 150 IUGONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day 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. When at least 1 follicle \>=18 mm and 2 follicles \>=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.–1 / 345 / 34
Gonal-f 187.5 IUGONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day 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. When at least 1 follicle \>=18 mm and 2 follicles \>=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.–1 / 2410 / 24
Gonal-f 225 IUGONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day 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. When at least 1 follicle \>=18 mm and 2 follicles \>=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.–0 / 103 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultOlivennes 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

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 34 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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