Letrozole Versus Gonadotropins in Clomiphene Citrate Resistance

NCT04834791 | Completed Phase 4

• 1 other identifier: CCR
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Clomiphene citrate resistance (CCR) occur in 15-40% in women with PCOS. Several studies have shown that letrozole is superior to CC regarding side effects, ovulation, and pregnancy rates. Letrozole or gonadotropins use for ovulation induction in CCR is not well established which is superior and most safe.

Conditions

Clomiphene Citrate Resistance; Ovulation Induction; Letrozole; Gonadotropins

Outcome Measures

Primary Outcomes (1)

• Ovulation rate

  Number of mature follicles in each ovary\>18mm

  6 months

Secondary Outcomes (1)

• Pregnancy rate

  6 months

Study Arms (2)

Letrozole

EXPERIMENTAL

These patients were treated with letrozole (Femara®, Novartis New York, NY, USA) in a dose 2.5 mg (one tablet daily) orally began on the 3rd day to the 7th day of the cycle. If ovulation is not achieved dose is increased by 2.5 mg in next cycle till 3 cycles.

Drug: Letrozole 2.5mg

Gonadotropins

ACTIVE COMPARATOR

These patients were given urofollitropin (fostimon ®, IBSA, Lugano, Switzerland) in a dose of 75 IU/mL I.M from day 3rd to day 7th of the cycle beginning by one ampoule per day and the dose had been modulated according to response.

Drug: Gonadotropin

Interventions

Letrozole 2.5mg DRUG

These patients were treated with letrozole (Femara®, Novartis New York, NY, USA) in a dose 2.5 mg (one tablet daily) orally began on the 3rd day to the 7th day of the cycle. If ovulation is not achieved dose is increased by 2.5 mg in next cycle till 3 cycles

Letrozole

Gonadotropin DRUG

These patients were given urofollitropin (fostimon ®, IBSA, Lugano, Switzerland) in a dose of 75 IU/mL I.M from day 3rd to day 7th of the cycle beginning by one ampoule per day and the dose had been modulated according to response.

Gonadotropins

Eligibility Criteria

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

You may qualify if:

• Infertility lasting one year or more in presence of regular intercourse,
• Patients' age between 20-35years
• Normal semen analysis according to WHO 2010
• Patent fallopian tubes (e) Normal prolactin and TSH.
• Anovulatory cycles confirmed by mid-luteal progesterone ≤ 3 ng/ml and
• Clomiphene citrate resistance for 3 cycles of 150mg.

You may not qualify if:

• Any hormonal disturbances eg. hyperprolactinemia,
• Immunological causes of infertility,
• Coital errors,
• Metabolic disorders and
• Poor patient compliance.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Ayman Shehata Dawood

Tanta, Gharbia Governorate, 31111, Egypt

Location

MeSH Terms

Interventions

Letrozole; Gonadotropins

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ayman Dawood, MD

  Assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 8, 2021
• Study Start: March 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 months

Locations

EG (1)