Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol
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
1 other identifier
interventional
132
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2023
CompletedFirst Submitted
Initial submission to the registry
April 9, 2024
CompletedFirst Posted
Study publicly available on registry
April 16, 2024
CompletedApril 16, 2024
April 1, 2024
12 months
April 9, 2024
April 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Pregnancy test
The participants required to make pregnancy test after taking the drugs of the study
2 weeks after ovulation
Study Arms (2)
Group A: letrozole only
ACTIVE COMPARATORAbout 66 Patients took Letrozole drug only for induction of ovulation at the time of suspected ovulation maturity.
Group B: letrozole + HCG
ACTIVE COMPARATORAbout 66 Patients took Letrozole drug in addition to HCG for induction of ovulation at the time of suspected ovulation maturity.
Interventions
To determine if the usage of All interventions are effective for simple induction of ovulation in polycystic ovarian syndrome in infertile couples.
Eligibility Criteria
You may qualify if:
- Infertile women with PCOS
- Normal hysterosalpingography
- Normal semen analysis according to WHO parameters are major prerequisites
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Egymedicalpedialead
Study Sites (1)
Ahmed Maher Teaching Hospital
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2024
First Posted
April 16, 2024
Study Start
November 10, 2022
Primary Completion
November 1, 2023
Study Completion
November 10, 2023
Last Updated
April 16, 2024
Record last verified: 2024-04