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Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality

Primary Purpose

Infertility, Female

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gonadotropin-Releasing Hormone Analogue
Gonadotropin releasing hormone antagonist
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Unexplained infertility.
  2. Tubal factor. Included treated hydrosalpinx and pyosalpinx
  3. first cycle .
  4. Body mass index: 18-29.
  5. Follicle stimulating hormone not more than 14 , E2 not more than 80 and Antimullerian hormone >1.
  6. Antral follicular count: more than 5 follicles in one ovary.
  7. combined factors .
  8. Normal male semen analysis: Mild male factor: concentrations 10 million - 20 million sperm/ml. Moderate male factor : concentrations 5 million - 10 million sperm/ml.

Exclusion Criteria:

  1. Patients with Endometriosis.
  2. Azoospermic male.
  3. Body mass index more than 29.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    agonist group

    antagonist group

    Arm Description

    Triptorelin at a dose 1 milligram per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation.

    •Multiple dose Gonadotrophin releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter .

    Outcomes

    Primary Outcome Measures

    number of maturated oocyte and good quality embryoes

    Secondary Outcome Measures

    clinical pregnancy outcome

    Full Information

    First Posted
    May 2, 2017
    Last Updated
    May 2, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03139474
    Brief Title
    Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality
    Official Title
    Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality in Intracytoplasmic Sperm Injection Cycles.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2017 (Anticipated)
    Primary Completion Date
    June 1, 2019 (Anticipated)
    Study Completion Date
    June 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The first In-Vitro Fertilization cycles were performed in natural unstimulated cycles. Today gonadotrophins are administered to induce multiple follicular development and controlled ovarian hyperstimulation. During ovarian stimulation gonadotrophin-releasing hormone analogues are co-administered in order to prevent premature luteinizing hormone surges. Premature luteinizing hormone surges are observed in about 20% of stimulated cycles without using gonadotrophin-releasing hormone analogues . Avoiding the adverse effects of elevated luteinizing hormone levels, first gonadotrophin-releasing hormone agonist analogues were used to supplement the gonadotrophin stimulation. The continuous administration of gonadotrophin-releasing hormone agonists causes gonadotrophin suppression through down-regulation and desensitization of the gonadotrophin-releasing hormone receptors in the pituitary gland after an initial short period of gonadotrophin hypersecretion . Gonadotrophin-releasing hormone antagonists (cetrorelix and ganirelix) cause immediate and rapid gonadotrophin suppression by competitive antagonism of the gonadotrophin-releasing hormone receptor in the pituitary without an initial period of gonadotrophin hypersecretion. Several advantageous effects of cetrorelix were established , and these effects seemed to be independent from the type of antagonist used for luteinizing hormone-suppression.The quality of oocytes and developing preembryos is one of the most relevant factors determining the success of an In-Vitro Fertilization treatment. As ovarian stimulation protocol is one of the eligible factors during an In-Vitro Fertilization treatment, its embryo quality influencing effects are necessary to know.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, Female

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    agonist group
    Arm Type
    Active Comparator
    Arm Description
    Triptorelin at a dose 1 milligram per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation.
    Arm Title
    antagonist group
    Arm Type
    Active Comparator
    Arm Description
    •Multiple dose Gonadotrophin releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter .
    Intervention Type
    Drug
    Intervention Name(s)
    Gonadotropin-Releasing Hormone Analogue
    Intervention Description
    Triptorelin at a dose 1 mg per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation.
    Intervention Type
    Drug
    Intervention Name(s)
    Gonadotropin releasing hormone antagonist
    Intervention Description
    antagonist group :Multiple dose gonadotrophin-releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter .We will give them gonadotrophin for 5 days , Triggering by Human Chorionic Gonadotrophin will be administered for each group when size of follicle reach > 17 millimeter .Oocytes will retrieved by transvaginal ultrasound , 34-36 hours after Human Chorionic Gonadotrophin administration .
    Primary Outcome Measure Information:
    Title
    number of maturated oocyte and good quality embryoes
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    clinical pregnancy outcome
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Unexplained infertility. Tubal factor. Included treated hydrosalpinx and pyosalpinx first cycle . Body mass index: 18-29. Follicle stimulating hormone not more than 14 , E2 not more than 80 and Antimullerian hormone >1. Antral follicular count: more than 5 follicles in one ovary. combined factors . Normal male semen analysis: Mild male factor: concentrations 10 million - 20 million sperm/ml. Moderate male factor : concentrations 5 million - 10 million sperm/ml. Exclusion Criteria: Patients with Endometriosis. Azoospermic male. Body mass index more than 29.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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