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Can adding estrogen to letrozole boost fertility in PCOS?

NCT ID NCT07379502

Disease control Sponsor: CMH Kharian Medical College Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study will test whether adding estradiol valerate to letrozole improves the uterine lining in 60 women with PCOS compared to letrozole alone. Participants will be randomly assigned to one of two groups and monitored via ultrasound. The goal is to see if the combination leads to a thicker, healthier endometrial lining, which may help with fertility.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Letrozole and Estradiol valerate
What this could lead to
If successful, this could point toward a better way to prepare the uterine lining in women with PCOS, potentially improving fertility treatment outcomes.
What could go wrong
This is a small, early-stage study with only 60 participants. It measures endometrial changes, not pregnancy rates, so success here may not lead to higher live birth rates. Results may not apply to all women with PCOS.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Mar 2026

Finished

Aug 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 35 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women aged 20-35 years * Clinical diagnosis of PMOS (Rotterdam criteria) Exclusion Criteria: * Endocrine disorders other than PMOS * Endometrial pathology or uterine malformations * Allergy to letrozole or estradiol * Hormonal therapy within last 3 months

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Conditions

The condition(s) this trial relates to.

polycystic ovary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PCOS (polycystic ovary syndrome) Polyendocrine metabolic ovarian syndrome (PMOS)

Contacts and locations

Locations

  • CMH Kharian Medical College

    Khārian, Punjab Province, 50070, Pakistan

More trials for these conditions

Other studies related to the condition(s) this trial covers.