Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol

NCT06367712
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Completed
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Participants
132
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Lead sponsor
Egymedicalpedia
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Start date
2022-11-10
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Number of sites
1
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Summary
Letrozole is a chemical compound, CGS 20267 which is a third-generation, nonsteroidal aromatase inhibitor. Letrozole blocks estrogen synthesis by directly affecting the hypothalamic-pituitary-ovarian axis, subsequently, increases gonadotropins which increase pregnancy rates. Possible positive outcomes of aromatase inhibitors over selective estrogen-receptor modulators include a more physiologic hormonal stimulation of the endometrium which increases receptivity, a lower multiple-pregnancy through single follicle growth, a lesser side-effect especially vasomotor and mood symptoms, and more prompt clearance from blood, hence, reducing the probabilities of periconceptional exposure
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Short title
Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol
clinicaltrials.gov
Official title
The Effect of Using Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol on Induction of Ovulation in Polycystic Ovarian Syndrome Patients: A Prospective Cohort Study
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2023-11-10
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First posted
2024-04-16
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Registry last updated
2024-04-16
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Primary completion date
2023-11-01
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Start date
2022-11-10
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Actual participants
132
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Participants
132
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Participant count basis
Actual
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Egymedicalpedia
clinicaltrials.gov
Source registry
ClinicalTrials.gov
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Registry ID
NCT06367712
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06367712
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Single masking
Masked roles
Participants
Sources for study design
clinicaltrials.gov

  1. Pregnancy test

    Timeframe: 2 weeks after ovulation

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

Sources for outcomes
clinicaltrials.gov

Sex
Female
Age groups
Adults
Minimum age
18 Years
Maximum age
35 Years
Healthy volunteers
No

  • Infertile women with PCOS
  • Normal hysterosalpingography
  • Normal semen analysis according to WHO parameters are major prerequisites

  • Infertile women with causes other than PCOS,
  • Ages <18 or >35 years
  • women taken confounding medications like other infertility drugs
  • Insulin sensitizers or hormones
  • Abnormal hysterosalpingography
  • Subnormal semen analysis
Sources for eligibility
clinicaltrials.gov

  • Ahmed Maher Teaching HospitalCairo, Egypt
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)