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

Subfertility Clinical Trial

Official title:

Effect of High BMI on Ovulation Induction Using Letrozole Versus Clomid

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04331197
• Other study ID #: Protocol 600
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: March 2020
• Source: Cairo University
• Contact: Eman Elkattan, MD,MRCOG,DFSRH
• Phone: 01212529213
• Email: emyelkattan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Infertility
• Subfertility

Intervention

Drug:
• Clomiphene Citrate 50mg
Clomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
• Letrozole 2.5mg
Femara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of ovulation	Raised concentration of serum progesterone	day 21 of 28 day cycle or 7 days post LH surge
Secondary	Number of mature follicles	Number of follicles> 15mm	day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days)
Secondary	Endometrial thickness	the thickest part of the endometrial lining at the longitudinal plane at the time of mature follicle	day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days)
Secondary	Conception	Number of participants with positive pregnancy test (serum or urine),serum BHCG > 25 IU/L	4-5 weeks post treatment
Secondary	clinical pregnancy	Number of participants with gestational sac with positive fatal pulsation	6 weeks post treatment