Combination Letrozole and Clomiphene Citrate Versus Letrozole Alone

NCT06507332 | Recruiting DMC

• 1 other identifier: Mohamed Adel Mousa
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Clomiphene citrate is a non-steroidal triphenylethylene derivative distantly related to diethylstilbestrol. It acts as a selective estrogen receptor modulator (SERM), similar to tamoxifen and raloxifene. All three drugs are competitive inhibitors of estrogen binding to estrogen receptors (ERs) and have mixed agonist and antagonist activity, depending upon the target tissue. Letrozole is a potent, nonsteroidal, aromatase inhibitor, originally used for postmenopausal breast cancer therapy.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Pregnancy Check

  The participants required to make pregnancy test after Receiving the drugs of the study

  2 weeks after ovulation

Study Arms (2)

Group 1 (Letrozole group)

ACTIVE COMPARATOR

About 32 patients will receive letrozole 2.5 mg tablets only , once daily from the third date of the menses for 5 days for 3 successive periods

Drug: Letrozole 2.5mg

Group 2 (Letrozole and Clomiphene Citrate)

ACTIVE COMPARATOR

About 32 patients will receive combined letrozole 2.5 mg tablets once daily and clomiphene citrate 50 mg tablets once daily from the third date of the menses for 5 days for 3 successive periods

Drug: Letrozole 2.5mg

Interventions

Letrozole 2.5mg DRUG

to assess and compare the efficacy of Combination of letrozole and clomiphene citrate versus letrozole alone for ovulation induction in women with polycystic ovary syndrome (PCOS)

Also known as: Clomiphene Citrate

Group 1 (Letrozole group); Group 2 (Letrozole and Clomiphene Citrate)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of infertility, defined as the inability of couple to achieve a pregnancy after 12 months of regular timed unprotected intercourse in women \<35 years of age or after 6 months in women \>35 years of age.
• Diagnosis of PCOS based on the Rotterdam criteria, including two of the following three findings: oligomenorrhea or chronic anovulation, hyperandrogenism (clinical or laboratory), and polycystic ovary(ies) on ultrasound .
• Normal HSG
• Normal semen analysis.
• Has capacity to participate in the study.

You may not qualify if:

• Unexplained infertility.
• Other conditions that can cause chronic anovulation and androgen excess such as hyperthyroidism by thyroid profile.
• congenital adrenal hyperplasia
• Cushing
• Untreated hyperprolactinemia.
• Medical conditions not well controlled or contraindicated to get pregnant with it like (uncontrolled diabetes mellitus, hypertension) .
• endometrial hyperplasia/cancer
• Allergy or contraindications to letrozole or CC. (by history)

Sponsors & Collaborators

• Egymedicalpedia: lead
• Ain Shams University: collaborator

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasia, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Letrozole; Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Dina Yahia, Professor

  Department of Obstetrics & Gynecology,Ain Shams University

  STUDY CHAIR

• Al Hassan Mohammad Khedr, Lecturer

  Department of Obstetrics & Gynecology,Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Adel Mousa, MSC

CONTACT

+201093429998; sedyyasedy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 18, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 10, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-03

Locations

EG (1)