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The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI (LH)

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
fix dose r-FSH (Gonal-f)
r-LH supplementation
r-FSH (Gonal-f)
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infertility focused on measuring ICSI, Suboptimal Ovarian Response, rLH

Eligibility Criteria

23 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 23-39
  • Body mass index between 18 and 30 kg/m2
  • Baseline FSH ≤12 IU/l, E2 ≤ 80 pg/ml
  • The presence of both ovaries and uterine cavity capable of sustaining a pregnancy
  • Who had regular menstrual cycles (21-35 days) Confirmed absence of pregnancy and sufficient number of antral follicles on the transvaginal US examination on the 3rd day of menstruation
  • Who were having their first or second IVF trial.

Exclusion Criteria:

  • Grade III-IV endometriosis
  • Clinically significant condition preventing them from undergoing gonadotrophin treatment
  • More than two previous assisted cycles
  • Who had a single ovary
  • Unexplained gynaecological bleeding
  • Polycystic ovary or an ovarian cyst of unknown aetiology
  • Previously diagnosed with a space occupying lesion like submucous myoma , polyps, septum, synechia in the uterine cavity
  • Have a chromosomal anomaly.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    fix dose r-FSH (Gonal-f)

    r-LH supplementation to r-FSH

    r-FSH (Gonal-f)

    Arm Description

    The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1

    On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.

    Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.

    Outcomes

    Primary Outcome Measures

    Pregnancy Rate
    percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml)

    Secondary Outcome Measures

    the Number of Oocytes Retrieved
    median number of oocytes retrieved per participant
    Number of Mature Oocyte
    median number of mature oocytes retrieved per participant
    Fertilization Rate
    fertilization rate used to measure how many oocytes become fertilized by sperm cells
    Implantation Rates
    Implantation rate is the percentage of embryos which successfully undergo implantation

    Full Information

    First Posted
    March 26, 2014
    Last Updated
    March 2, 2015
    Sponsor
    Sisli Hamidiye Etfal Training and Research Hospital
    Collaborators
    Selcuk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02108223
    Brief Title
    The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI
    Acronym
    LH
    Official Title
    In This Study, the Addition of rLH, Increasing the Dose of rFSH and the Control Groups Regarding the Results of IVF in These Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sisli Hamidiye Etfal Training and Research Hospital
    Collaborators
    Selcuk University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.
    Detailed Description
    Aim -We aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. We evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients. Material and Methods -Between 01.01.2009-30.04.2011, 137 patients presented with infertility to the unit of Assisted Reproduction Techniques- of the Department of Obstetrics and Gynecology- Meram Medical Faculty- Selcuk University and were planned for ICSI-ET (intracytoplasmic sperm injection-embryo transfer) with normal ovarian function, who had long protocol of GnRH analogue and COH (controlled ovarian hyperstimulation) with rFSH were included in the study. 52 patients were considered responsive to stimulation and composed the normal control group (Group 1). On the 7th day of stimulation transvaginal ultrasonography was carried out. Patients who had at least 6 follicles about 6-10mm but had no follicle above 10mm and E2 (Oestradiol) level of <250 pg / ml were considered to have suboptimal response to stimulation and were divided into two groups. For Group 2 (n = 50), 75IU / L rLH was added to the treatment, for Group 3 (n = 35), 75IU / L of rFSH was added to the treatment. IVF results were compared between the groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility
    Keywords
    ICSI, Suboptimal Ovarian Response, rLH

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    137 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    fix dose r-FSH (Gonal-f)
    Arm Type
    Active Comparator
    Arm Description
    The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
    Arm Title
    r-LH supplementation to r-FSH
    Arm Type
    Active Comparator
    Arm Description
    On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
    Arm Title
    r-FSH (Gonal-f)
    Arm Type
    Active Comparator
    Arm Description
    Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
    Intervention Type
    Drug
    Intervention Name(s)
    fix dose r-FSH (Gonal-f)
    Other Intervention Name(s)
    puregon
    Intervention Description
    recombinant follicle stimulation
    Intervention Type
    Drug
    Intervention Name(s)
    r-LH supplementation
    Other Intervention Name(s)
    luveris
    Intervention Description
    recombinant luteinizing hormone
    Intervention Type
    Drug
    Intervention Name(s)
    r-FSH (Gonal-f)
    Other Intervention Name(s)
    puregon
    Intervention Description
    recombinant follicle stimulation hormone
    Primary Outcome Measure Information:
    Title
    Pregnancy Rate
    Description
    percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml)
    Time Frame
    Up to 9 month
    Secondary Outcome Measure Information:
    Title
    the Number of Oocytes Retrieved
    Description
    median number of oocytes retrieved per participant
    Time Frame
    up to 9 month
    Title
    Number of Mature Oocyte
    Description
    median number of mature oocytes retrieved per participant
    Time Frame
    up to 9 month
    Title
    Fertilization Rate
    Description
    fertilization rate used to measure how many oocytes become fertilized by sperm cells
    Time Frame
    up to 9 month
    Title
    Implantation Rates
    Description
    Implantation rate is the percentage of embryos which successfully undergo implantation
    Time Frame
    up to 9 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    23 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 23-39 Body mass index between 18 and 30 kg/m2 Baseline FSH ≤12 IU/l, E2 ≤ 80 pg/ml The presence of both ovaries and uterine cavity capable of sustaining a pregnancy Who had regular menstrual cycles (21-35 days) Confirmed absence of pregnancy and sufficient number of antral follicles on the transvaginal US examination on the 3rd day of menstruation Who were having their first or second IVF trial. Exclusion Criteria: Grade III-IV endometriosis Clinically significant condition preventing them from undergoing gonadotrophin treatment More than two previous assisted cycles Who had a single ovary Unexplained gynaecological bleeding Polycystic ovary or an ovarian cyst of unknown aetiology Previously diagnosed with a space occupying lesion like submucous myoma , polyps, septum, synechia in the uterine cavity Have a chromosomal anomaly.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    fatma yazıcı yılmaz, MD
    Organizational Affiliation
    Sisli Etfal training and research hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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