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
About this trial
This is an interventional treatment trial for Subfertility
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 .
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
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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