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Ovarian StimulationNCT05166668

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

A study testing Letrozole 2.5mg tablet in people with Ovarian Stimulation, run by Menoufia University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 40 to 44 years, women only
Conditions the study is for
Ovarian Stimulation
What is being tested?
Letrozole 2.5mg tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteEgypt
Study dates
1 Nov 2021to 10 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 44 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Menoufia University hospital

    Shibīn al Kawm, Menoufia, 11111

Other trials in Egypt

About this study

Official title: Impact of Adding Letrozole to Gonadotrophin-Releasing Hormone Antagonist Protocol in Women Over 40 Years Undergoing ICSI Cycle

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

Being tested
Letrozole 2.5mg tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Letrozole 2.5mg tabletDrug

    Also called Gonadotropins units

    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

Study groups in NCT05166668
Study groupRoleWhat they receive
standard GnRH antagonist protocolActive comparatorGonadotropins (300-450 IU) IM start on cycle day 2 then the dose modulated according to response
Receives: Drug: Letrozole 2.5mg tablet
Aromatase inhibitor/flexible antagonist protocolActive comparatorletrozole 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
Receives: Drug: Letrozole 2.5mg tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. live birth rate

    deliveries ≥22 weeks gestation with heartbeat and breath

    Measured: 1 year after embryo transfer

Secondary outcomes (7)
  1. positive hCG

    serum β-hCG ≥10 mIU/mL

    Measured: 2 weeks after FET

  2. clinical pregnancy

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

    Measured: 5 weeks' gestation

  3. Total gonadotropin /cycle (IU),

    number of gonadotropin units needed per cycle

    Measured: two weeks

  4. Duration of stimulation (Day),

    number of days needed for stimulation

    Measured: two weeks

  5. Endometrial thickness (mm)

    measure endometrial thickness

    Measured: two weeks

  6. serum E2 levels

    measuring E2 level during stimulation

    Measured: two weeks

  7. Follicles number

    number of follicles during stimulation

    Measured: two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2021
  2. Study start1 Nov 2021
  3. Primary completion10 Feb 2025
  4. Study completion10 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05166668
Sponsor's protocol ID
12/2021OBSGN 1
Status last verified
Feb 2025
First submitted
8 Dec 2021
Last updated
12 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Letrozole 2.5mg tablet in people with Ovarian Stimulation, run by Menoufia University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

live birth rate (time frame: 1 year after embryo transfer). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.

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