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Taking people in SpainPhase 3

Letrozole compared with gonadotropins for insemination in polycystic ovary syndrome

Compares letrozole with gonadotropins before artificial insemination in women with polycystic ovary syndrome.

Key facts

Who runs it
Hospital Universitario La Paz
Where
Madrid, SpainSee the site
Registry title
Insemination in patients with polycystic ovary syndrome: gestation rates using two stimulation patterns: letrozole vs gonadotropins.
Status
Recruiting
Phase
Phase 3
People taking part
100 people, planned
Started
15 Dec 2023
Planned end
1 Oct 2026
Type of study
Interventional
Record updated
9 October 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with polycystic ovary syndrome (PCOS) and infertility who are planned for artificial insemination. It compares letrozole with gonadotropins to stimulate the ovaries.

Age
Women between 18-40 years old (the registry age fields say 18 Years to 64 Years).
Sex
Women only.
Disease stage
PCOS diagnosed by the Rotterdam criteria. Primary or secondary infertility, with a reason to have insemination. Body mass index (BMI) ≥18 and ≤30.
Earlier treatment
People who did not respond to letrozole in earlier cycles to trigger egg release cannot join. People in an in vitro fertilization (IVF) program cannot join.

Main reasons for not taking part

  • BMI <18 or >30
  • Any body-wide disease or poorly controlled hormone disorder that may affect the study
  • Uterus malformations, many fibroids (except subserosal or intramural fibroids <5cm (2 in) that do not change the shape of the womb), or moderate to severe endometriosis
  • Past or current pelvic inflammatory disease, narrowing of the cervix, or an untreated blocked, fluid-filled tube (hydrosalpinx)
  • Severe sperm problems in the male partner (cryptozoospermia, oligoasthenoteratozoospermia or low REM < 5 million)

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • Age: women between 18-40 years old
  • Body mass index (BMI): ≥18 and ≤30
  • Primary or secondary infertility
  • Diagnosis of PCOS according to Rotterdam criteria (The Rotterdam ESHRE/ASRM- sponsored PCOS Consensus Workshop Group Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod 2004; 19: 41-47)
  • Insemination indication
  • Women giving informed consent to participate in the study

Who cannot take part

  • Presence of any systemic disease or poorly controlled endocrinological pathology that may interfere with the objectives of the study
  • History or presence of Pelvic Inflammatory Disease
  • Women with BMI <18 or >30
  • Verification by vaginal ultrasound of the presence of any residual follicle or corpus luteum
  • Patients who have not responded to letrozole in ovulation induction cycles
  • Contraindication to the use of any of the treatments foreseen by the study in the terms established in the protocol
  • Women in in vitro fertilization program
  • Presence of uterine malformations
  • Presence of polymyomatous uterus, with the exception of subserosal or intramural myomas <5cm that do not deform the uterine cavity
  • Moderate and severe endometriosis
  • Interventions on cervix that may have originated a stenosis and/or cervical stenosis at the beginning of the study
  • Unexcised or occluded hydrosalpinx
  • Existence of severe male factor: cryptozoospermia or oligoasthenoteratozoospermia or with low REM (< 5 million)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 64 years old?

Where in Spain

  • Hospital Universitario La PazMadrid, SpainTaking people

About the trial

What the trial wants to find out

The main objective of the research study is to know if letrozole is a therapeutic alternative to gonadotropins in artificial inseminations in patients with polycystic ovary in terms of gestation rate and live birth rate.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Insemination in patients with polycystic ovary syndrome: gestation rates using two stimulation patterns: letrozole vs gonadotropins.
Plain-language title
Letrozole compared with gonadotropins for insemination in polycystic ovary syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from 2023-503477-38-00, who can take part
Record updated
9 October 2023