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

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04331197
• Collaborator: (none)
• Enrollment: 160
• Arms: 2
• Anticipated Duration (Months): 13

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Subfertility	Drug: Clomiphene Citrate 50mg; Drug: Letrozole 2.5mg	Phase 4

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 .

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of High BMI on Ovulation Induction Using Letrozole Versus Clomid
• Anticipated Study Start Date: May 1, 2020
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Clomiphene Citrate-High BMI women Clomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days	Drug: Clomiphene Citrate 50mg; Clomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days; Other Names: Clomid
Active Comparator: Letrozole-High BMI women Femara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days	Drug: Letrozole 2.5mg; Femara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days

Outcome Measures

Primary Outcome Measures

1. Evidence of ovulation [day 21 of 28 day cycle or 7 days post LH surge]

   Raised concentration of serum progesterone

Secondary Outcome Measures

1. Number of mature follicles [day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days)]

   Number of follicles> 15mm

2. Endometrial thickness [day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days)]

   the thickest part of the endometrial lining at the longitudinal plane at the time of mature follicle

3. Conception [4-5 weeks post treatment]

   Number of participants with positive pregnancy test (serum or urine),serum BHCG > 25 IU/L

4. clinical pregnancy [6 weeks post treatment]

   Number of participants with gestational sac with positive fatal pulsation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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 .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eman Elkattan, Associate professor, Cairo University
• ClinicalTrials.gov Identifier: NCT04331197
• Other Study ID Numbers: Protocol 600
• First Posted: Apr 2, 2020
• Last Update Posted: Apr 2, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Letrozole; Clomiphene; Enclomiphene; Zuclomiphene

Study Results

No Results Posted as of Apr 2, 2020