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Second dose letrozole ovulation treatment in PCOS infertility patients

Letrozle second dose compared to gonadotropin therapy after letrozole initial dose non-response in PCOS infertility patients: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019630
Enrollment
Unknown
Registered
2018-11-20
Start date
2018-12-01
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

Polycystic ovary syndrome

Interventions

letrozole second dose after non-response to initial letrozole dose:Letrozole 2.5mg/d(BMI=25kg/m2), 5mg/d(BMI>25kg/m2), for cycle day 3 to 7
Letrozole 5mg/d(BMI=25kg/m2),7.5mg/d(BMI>25kg/m2) , for cycle day 9 to 11
HCG 10000u on day of trigger
Gonadotropin group:Letrozole 2.5mg/d(BMI=25kg/m2), 5mg/d(BMI>25kg/m2), for cycle day 3 to 7
HMG/rFSH 75u/d, for cycle day9 to 11,if response continued same dose until day of trigger, if no response HMG/rFSH 112.5u from cycle day12 to 14, if response continued same dose until day of trigger

Sponsors

Shenzhen Maternity and Child Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
21 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. aged 21-40 years; 2. according to two of the three following criteria: no ovulation (irregular menstrual cycle, ); high androgen levels (serum testosterone >/=0.75ug/L) and/or clinical signs of androgen excess; polycystic ovaries (>/=12 antral follicles in every ovary); 3. at least 1 year of infertility till recruit; 4. at least one open fallopian tube and a normal uterine cavity confirmed by HSG, ultrasonography, laparoscopy and/or hysteroscopy.

Exclusion criteria

Exclusion criteria: 1. suffer from other uncontrolled endocrine disease that might cause infertility, such as hyperthyroidism or congenital adrenal hyperplasia; 2. suffer from other gynecologic disease that might cause infertility, such as endometriosis or adenomyosis; 3. severe organ dysfunction or mental illness; 4. BMI >30 would recommend 5% weight loss before recruit.

Design outcomes

Primary

MeasureTime frame
ovulation;

Secondary

MeasureTime frame
serum human chorionic gonadotropin level;

Countries

China

Contacts

Public ContactLI Xuemei

Shenzhen Maternity and Child Healthcare Hospital

842326015@qq.com+86 13500052909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026