BMI Effect on the Response to Ovulation Induction in Letrozole vs Clomid
Effect of High BMI on Ovulation Induction Using Letrozole Versus Clomid
1 other identifier
interventional
160
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2020
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2020
CompletedFirst Posted
Study publicly available on registry
April 2, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedApril 2, 2020
March 1, 2020
1 year
March 27, 2020
March 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Evidence of ovulation
Raised concentration of serum progesterone
day 21 of 28 day cycle or 7 days post LH surge
Secondary Outcomes (4)
Number of mature follicles
day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days)
Endometrial thickness
day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days)
Conception
4-5 weeks post treatment
clinical pregnancy
6 weeks post treatment
Study Arms (2)
Clomiphene Citrate-High BMI women
ACTIVE COMPARATORClomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
Letrozole-High BMI women
ACTIVE COMPARATORFemara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
March 27, 2020
First Posted
April 2, 2020
Study Start
May 1, 2020
Primary Completion
May 1, 2021
Study Completion
June 1, 2021
Last Updated
April 2, 2020
Record last verified: 2020-03