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CompletedNCT05166668Updated Feb 12, 2025

Letrozole /GnRH Antagonist Protocol in Women Over 40 Years Undergoing ICSI Cycle

An interventional study of Letrozole 2.5mg tablet in Ovarian Stimulation, sponsored by Menoufia University. Completed at 1 site in Egypt. Open to female participants aged 40 Years to 44 Years. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Menoufia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
40 Years to 44 Years
Sex
Female
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Study summary

The aim of this study To compare the clinical and laboratory outcomes of two ovarian stimulation protocols (standard GnRH antagonist protocol and aromatase inhibitor/ antagonist protocol) in women (40-44) years undergoing ICSI cycle.

Read the detailed description

Fertility is known to decline significantly in women after the age of 35 years, and fecundity is almost completely lost after the age of 45 . As age increases the natural fecundity and pregnancy rates after assisted reproduction decrease .This reduction in fecundity is thought to be due to ovarian aging mainly, which is defined as a decline in both the quantity and quality of the ovarian follicle pool .The increase in patient's age is associated with poor ovarian response, as represented by smaller ovarian volume, lower antral follicle count and poor stromal vascularity. In addition to the reduction in fecundity, there is an increase in spontaneous abortion rates in this group of women .It has been reported that about 19% of all women undergo ART are 40 years, and they could be considered as expected poor responders .Various protocols of ovarian stimulation have been proposed to optimize IVF results in this age group, however, satisfactory results remain a challenge . The lack of initial central down-regulation in early follicular phase and adequate prevention of premature luteinizing hormone (LH) surge in late follicular phase provide GnRH antagonist protocol as a potentially proper option .The use of aromatase inhibitors in a GnRH antagonist protocol was suggested by some studies [Mit. Yarali and colleagues demonstrated that adjuvant therapy with letrozole could improve the response [Yarali et al., 2009]. Meanwhile, in another study, adding letrozole to ovarian stimulation has no positive effect on the likelihood of pregnancy . Letrozole is a selective, non-steroidal third generation aromatase inhibitor. Letrozole causes a reduction in conversion of androstenedione and testosterone to estrone and estradiol by inhibiting the aromatase enzyme activity . According to some published studies, the decline in early follicular phase estrogen levels, and consequently decrease in negative feedback of estrogen on FSH release in hypothalamic-pituitary axis cause an increase in endogenous gonadotropin secretion and stimulation of ovarian follicular growth. In addition, an increase in intraovarian androgens secondary to aromatase inhibition, augments the follicular sensitivity to FSH stimulation and follicular growth . Letrozole has no antiestrogenic effect over the endometrium . These reports prompted us to hypothesize that use of letrozole as a co-treatment agent in GnRH antagonist protocol might enhance cycle outcomes.

I

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Conditions studied

  • Ovarian Stimulation
03

In context

Lead sponsor

Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women between 40- 44-years undergoing ICSI cycle with FSH less than 15 and AMH more than 0.30.

Exclusion criteria

Exclusion Criteria:

  • Azoospermia in male partner,
  • Previous ovarian surgery,
  • Severe endometriosis,
  • Uterine cavity lesion
  • Metabolic or endocrine disorders including hyperprolactinemia and ypo/hyperthyroidism.
  • Previous failed ICSI cycle.
  • BMI more than 30.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    standard GnRH antagonist protocol

    Gonadotropins (300-450 IU) IM start on cycle day 2 then the dose modulated according to response

    Drug: Letrozole 2.5mg tablet

  • Active comparator
    Aromatase inhibitor/flexible antagonist protocol

    letrozole orally in a dose of 2.5 mg daily, on day 2 of cycle for 5 days and gonadotropins (300-450 IU) IM start on cycle day 3. then the dose modulated according to response

    Drug: Letrozole 2.5mg tablet

Interventions

  • DrugLetrozole 2.5mg tablet

    letrozole (femara, Novartis) orally in a dose of 2.5 mg daily, on day 2 of cycle for 5 days and gonadotropins (300-450 IU) IM start on cycle day 3. then the dose modulated according to response

    Also known as: Gonadotropins units

06

What researchers measure

Primary outcomes

  1. live birth rate

    deliveries ≥22 weeks gestation with heartbeat and breath

    Time frame: 1 year after embryo transfer

Secondary outcomes

  1. positive hCG

    serum β-hCG ≥10 mIU/mL

    Time frame: 2 weeks after FET

  2. clinical pregnancy

    presence of intrauterine gestational sac by trans-vaginal ultrasound at gestational weeks.

    Time frame: 5 weeks' gestation

  3. Total gonadotropin /cycle (IU),

    number of gonadotropin units needed per cycle

    Time frame: two weeks

  4. Duration of stimulation (Day),

    number of days needed for stimulation

    Time frame: two weeks

  5. Endometrial thickness (mm)

    measure endometrial thickness

    Time frame: two weeks

  6. serum E2 levels

    measuring E2 level during stimulation

    Time frame: two weeks

  7. Follicles number

    number of follicles during stimulation

    Time frame: two weeks

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Study locations

1 site
  • Menoufia University hospital
    Shibīn Al Kawm, Menoufia 11111, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05166668
Lead sponsor
Menoufia University
Responsible party
Mohamed Elsibai Anter (Assistant professor of obstetrics and gynecology, Menoufia University) — Principal investigator
First posted
Dec 22, 2021
Start date
Nov 1, 2021
Primary completion
Feb 10, 2025
Completion
Feb 10, 2025
Last update
Feb 12, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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