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Different doses of letrozole combined sequentially as letrozole+urofollitropin for treating anovulatory infertility in patients with polycystic ovary syndrome: A pragmatic randomized controlled trial

Different doses of letrozole combined sequentially as letrozole+urofollitropin for treating anovulatory infertility in patients with polycystic ovary syndrome: A pragmatic randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069638
Enrollment
Unknown
Registered
2023-03-22
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic ovary syndrome

Interventions

Group A:2.5mg+FSH
GroupB:5.0mg+FSH

Sponsors

Union Hospital,Tongji Medical College,Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) Patients with PCOS who meet the Rotterdam diagnostic criteria in 2003: (1) Patients with rare ovulation or even anovulation; (2) Clinical symptoms or biochemical manifestations of hyperandrogenism; (3) Abdominal ultrasound shows polycystic changes in the ovaries (vaginal ultrasound shows that one or even both ovaries contain more than 12 follicles with a diameter of 2-9mm). Diagnosis can be made if two of the above three criteria are met. (2) Patients under 40 years old, with normal sexual activity and infertility for at least 1 year. (3) Hysterosalpingography shows normal uterine morphology and at least one patent fallopian tube. (4) The results of the spouse's semen analysis are normal or mildly oligoasthenozoospermia. (5) All organ functions are normal and there are no accompanying endocrine diseases such as pituitary dysfunction or hyperthyroidism. (6) The patient has been fully informed of the nature, significance, potential benefits, inconveniences, and potential risks of the clinical trial, voluntarily participates in the study, can communicate well with the researchers, comply with the requirements of the entire study, and has signed a written informed consent form.

Exclusion criteria

Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded: (1) known allergy to relevant drugs; (2) participation in other drug clinical trials within the past 3 months; (3) clinical evidence of diseases that need to be excluded upon inquiry, including but not limited to neurological, cardiovascular, hematological and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal system diseases, and the researcher believes that these diseases may affect the subject's participation in the study results or safety; (4) history of uterine or uterine cavity abnormal diseases; (5) previous exposure to teratogenic substances, radiation, etc.; (6) subjects who the researcher believes have poor compliance or any factors that are not suitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
Ovulation rate;pregnancy rate;Clinical pregnancy rate;ongoing pregnancy rate;

Countries

China

Contacts

Public ContactLiu Yi

Union Hospital,Tongji Medical College,Huazhong University of Science and Technology

liqun94@163.com+86 13971038710

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026