A Phase 4 interventional study of Clomiphene Citrate 50mg and Letrozole 2.5mg in Subfertility, sponsored by Cairo University. Status unknown. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-04-02.
Sponsored by Cairo University · Phase 4, Interventional, and Treatment
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.
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 .
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 160 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Clomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
Drug: Clomiphene Citrate 50mg
Femara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
Drug: Letrozole 2.5mg
Clomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
Also known as: Clomid
Femara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
Evidence of ovulation
Raised concentration of serum progesterone
Time frame: day 21 of 28 day cycle or 7 days post LH surge
Number of mature follicles
Number of follicles\> 15mm
Time frame: day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days)
Endometrial thickness
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)
Conception
Number of participants with positive pregnancy test (serum or urine),serum BHCG \> 25 IU/L
Time frame: 4-5 weeks post treatment
clinical pregnancy
Number of participants with gestational sac with positive fatal pulsation
Time frame: 6 weeks post treatment
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Cairo University