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Evaluation of the effectiveness of letrozole pretreatment combined with conventional gonadotropin ovulation induction therapy in assisted reproductive technology for women with advanced age or diminished ovarian reserve: a multicenter, prospective, randomized, open label, controlled trial

Evaluation of the effectiveness of letrozole pretreatment combined with conventional gonadotropin ovulation induction therapy in assisted reproductive technology for women with advanced age or diminished ovarian reserve: a multicenter, prospective, randomized, open label, controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029272
Enrollment
Unknown
Registered
2020-01-19
Start date
2020-03-01
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

Diminished ovarian reserve

Interventions

Experimental group:take letrozole 5mg orally for 5 consecutive days on the 2nd day of the menstrual cycle, subcutaneous gonadotropin 300U injection for 2 consecutive days on the 5th day of the menstru
Control group:subcutaneous gonadotropin 300U injection for 5 consecutive days on the 2nd day of the menstrual cycle

Sponsors

Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
No minimum to 45 Years

Inclusion criteria

Inclusion criteria: 1. People with advanced age or diminished ovarian reserve: (1) aged from 40 to 45 years; (2) patients with ovarian reserve dysfunction: aged <40 years, combined with AFC <5 or AMH <1.2 ng/mL. 2. Proposed 1-3 cycle IVF or ICSI; 3. The patient agrees to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) AMH < 0.1 ng/mL; (2) unilateral or bilateral hydrosalpinx; (3) combined uterine diseases, such as uterine malformation (uterus unicornis, uterus bicornis, uterus duplex, uterus septus), adenomyosis, intrauterine adhesions, untreated endometrial polyps and/or submucosal fibroids; (4) Both spouses or one spouse have chromosomal abnormalities; (5) Male dysfunction, non-obstructive azoospermia or AZF gene microdeletion; (6) allergic to letrozole or Gn; (7) Patients with contraindications to assisted reproductive technology or pregnancy,such as uncontrolled diabetes, undiagnosed liver and kidney dysfunction, history of deep vein thrombosis, history of pulmonary embolism, history of cerebrovascular accident, uncontrolled hypertension , heart disease, suspected cervical cancer, endometrial cancer, breast cancer or previous medical history, undiagnosed vaginal bleeding; (8) Unable to follow up or poor compliance, or the investigator believes that there exist factors affecting the subject's participation in the trial or outcome evaluation.

Design outcomes

Primary

MeasureTime frame
Cumulative clinical pregnancy rate of one ovulation induction;

Secondary

MeasureTime frame
number of retrieved oocytes;rate of pregnancy loss;live birth rate;

Countries

China

Contacts

Public ContactXiaomiao Zhao

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

zhaoxmiao@163.com+86 13922209605

Outcome results

None listed

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