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BMI Effect on the Response to Ovulation Induction in Letrozole vs Clomid

Primary Purpose

Subfertility

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Clomiphene Citrate 50mg
Letrozole 2.5mg
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subfertility

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 18-45 years old.
  • History of subfertility for 2 years.
  • No previous IVF
  • Intact tubes as evidenced by HSG or Hycosy
  • Normal Sperm parameters according to WHO criteria.
  • Ability to have regular intercourse during the ovulation induction phase of the study.

Exclusion Criteria:

  • Age less than 18 years old or older than 45 years old.
  • FSH> 15 mIU/ml
  • Tubal factor of infertility
  • Male factor of infertility
  • Current pregnancy,abnormal uterine bleeding.
  • History of use of hormonal contraception in the last 3 months.
  • Untreated medical problems: thyroid disease,hyperprolactinemia or contraindication to pregnancy as uncontrolled diabetes or severe heart disease.
  • Contraindications to clomiphene citrate: hypersensitivity to clomid.
  • Contraindications to letrozole: hypersensitivity to letrozole .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Clomiphene Citrate-High BMI women

    Letrozole-High BMI women

    Arm Description

    Clomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days

    Femara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days

    Outcomes

    Primary Outcome Measures

    Evidence of ovulation
    Raised concentration of serum progesterone

    Secondary Outcome Measures

    Number of mature follicles
    Number of follicles> 15mm
    Endometrial thickness
    the thickest part of the endometrial lining at the longitudinal plane at the time of mature follicle
    Conception
    Number of participants with positive pregnancy test (serum or urine),serum BHCG > 25 IU/L
    clinical pregnancy
    Number of participants with gestational sac with positive fatal pulsation

    Full Information

    First Posted
    March 27, 2020
    Last Updated
    March 31, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04331197
    Brief Title
    BMI Effect on the Response to Ovulation Induction in Letrozole vs Clomid
    Official Title
    Effect of High BMI on Ovulation Induction Using Letrozole Versus Clomid
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2020 (Anticipated)
    Primary Completion Date
    May 1, 2021 (Anticipated)
    Study Completion Date
    June 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    There is an increased prevalence of high Body mass index (BMI) all over the world.High BMI is shown to have an impact on the female reproductive system.It can contribute to both ovulatory and anovulatory subfertility. Clomiphene citrate and Letrozole have been used for treatment of infertility.Both are used for induction of ovulation. Clomiphene citrate is an estrogen receptor antagonist .It increases serum FSH and it has its limitation due to his antiestrogenic effect,it has an ovulation rate 70-80% but pregnancy rate is only 22% because of its anti-estrogenic effect on endometrium and poor cervical mucus (Legro RS et al.,2007) Letrozole is an aromatase inhibitor which inhibits the production of estrogen, which influences the action of the brain's hypothalamus and pituitary on the functioning of the ovaries by increasing FSH.Due to the antiestrogenic effect of clomiphene citrate,Letrozole can be used as an alternative. The investigators are comparing the effect of both medications on the outcome of the induction of ovulation in women with high BMI.
    Detailed Description
    This is a Randomized controlled trial .The researchers include160 women with BMI more than 30 who were suffering from subfertility for more than 2 years. The investigators will randomise them into 2 groups. Group A:They were prescribed 100 mg of clomiphene citrate from day 2-5 of the cycle for 5 days. Group B : They were prescribed 5 mg of Letrozole from day 2-5 of the cycle. Vaginal ultrasound was performed on day 11 of the cycle, After at least one follicle reached 15 mm, The patient was encouraged to have sexual intercourse every other day for few days.The patients will have a midluteal progesterone level to confirm ovulation and will have a pregnancy test in 2 weeks if missed period. The researchers will compare the number of mature follicles, endometrial thickness on the day when there are mature follicles, occurrence of pregnancy, multiple pregnancies, and miscarriages .

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Clomiphene Citrate-High BMI women
    Arm Type
    Active Comparator
    Arm Description
    Clomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
    Arm Title
    Letrozole-High BMI women
    Arm Type
    Active Comparator
    Arm Description
    Femara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
    Intervention Type
    Drug
    Intervention Name(s)
    Clomiphene Citrate 50mg
    Other Intervention Name(s)
    Clomid
    Intervention Description
    Clomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
    Intervention Type
    Drug
    Intervention Name(s)
    Letrozole 2.5mg
    Intervention Description
    Femara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
    Primary Outcome Measure Information:
    Title
    Evidence of ovulation
    Description
    Raised concentration of serum progesterone
    Time Frame
    day 21 of 28 day cycle or 7 days post LH surge
    Secondary Outcome Measure Information:
    Title
    Number of mature follicles
    Description
    Number of follicles> 15mm
    Time Frame
    day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days)
    Title
    Endometrial thickness
    Description
    the thickest part of the endometrial lining at the longitudinal plane at the time of mature follicle
    Time Frame
    day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days)
    Title
    Conception
    Description
    Number of participants with positive pregnancy test (serum or urine),serum BHCG > 25 IU/L
    Time Frame
    4-5 weeks post treatment
    Title
    clinical pregnancy
    Description
    Number of participants with gestational sac with positive fatal pulsation
    Time Frame
    6 weeks post treatment

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: 18-45 years old. History of subfertility for 2 years. No previous IVF Intact tubes as evidenced by HSG or Hycosy Normal Sperm parameters according to WHO criteria. Ability to have regular intercourse during the ovulation induction phase of the study. Exclusion Criteria: Age less than 18 years old or older than 45 years old. FSH> 15 mIU/ml Tubal factor of infertility Male factor of infertility Current pregnancy,abnormal uterine bleeding. History of use of hormonal contraception in the last 3 months. Untreated medical problems: thyroid disease,hyperprolactinemia or contraindication to pregnancy as uncontrolled diabetes or severe heart disease. Contraindications to clomiphene citrate: hypersensitivity to clomid. Contraindications to letrozole: hypersensitivity to letrozole .
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman Elkattan, MD,MRCOG,DFSRH
    Phone
    01212529213
    Email
    emyelkattan@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amira Saeed, MD
    Email
    amirasaied2026@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    BMI Effect on the Response to Ovulation Induction in Letrozole vs Clomid

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