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An adaptive platform trial for evaluating ovulation induction treatments and effect on pregnancy outcomes in women with PCOS: Rationale and proposal

An adaptive platform trial for evaluating ovulation induction treatments and effect on pregnancy outcomes in women with PCOS: Rationale and proposal

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094631
Enrollment
Unknown
Registered
2024-12-25
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Polycystic Ovary Syndrome (PCOS)

Interventions

Group A:LE group. Letrozole is taken orally on the 3-5 day of the menstrual cycle.
Group B:LE+Gn group. Letrozole is taken orally on the 3-5 day of the menstrual cycle, and gonadotropin is intramuscularly injected.
Group C:CC group, Clomiphene citrate, CC is taken orally on the 3-5 day of the menstrual cycle.

Sponsors

The Seventh Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Woman with PCOS meeting the 2003 Rotterdam diagnostic criteria; 2.Age less than 40 years old, normal sex life, infertility course for more than 1 year; 3.hysterosalpingography indicated that the uterine morphology was normal, and at least one side of the fallopian tube was unobstructed; 4.There was no abnormal or mild oligospermia or asthenospermia in the sperm analysis results of the spouses; 5.all organs function normally, without any endocrine disorders, such as hypophysis, hyperthyroidism; 6.Before the trial, they have understood in detail the nature, significance, possible benefits and potential dangers of the trial, and have voluntarily participated in the clinical trial, communicated well with the investigator, complied with the requirements of the entire study, and have signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Diseases with abnormal clinical manifestations to be excluded, including, but not limited to, neurological, cardiovascular, hematologic and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal systemic disorders that, in the opinion of the Investigator, may affect the outcome or safety of the subject's participation in the study; 2.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; 3.Patients with suspected or confirmed pregnancy; patients breastfeeding within six months; 4.Participation in other drug clinical trials within the past 3 months; 5.Diseases with abnormal clinical manifestations to be excluded, including, but not limited to, neurological, cardiovascular, hematologic and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal systemic disorders that, in the opinion of the Investigator, may affect the outcome or safety of the subject's participation in the study; 6.History of uterine or uterine cavity abnormal diseases; 7.Previous exposure to teratogenic substances, radiation, etc; 8.Patients with relevant drug contraindications: e.g., history of breast cancer, history of venous thrombosis, history of migraine, history of severe liver disease; 9.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;Clinical pregnancy rate;

Secondary

MeasureTime frame
Number of antral follicles;Number of mature follicles;Endometrial thickness;The level of progesterone;The level of estradiol;The level of luteinizing hormone;The rate of OHSS;Cumulative pregnancy rate;Ongoing pregnancy rate;Biochemical pregnancy rate;Pregnancy loss rate;Early abortion rate;live birth rate;Ectopic pregnancy rate;Mutiple pregnancy rate;

Countries

China

Contacts

Public ContactMa Lin

The Seventh Affiliated Hospital Sun Yat-sen University

malin@mail.sysu.edu.cn+86 13903056356

Outcome results

None listed

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