Efficacy and safety of letrozole combined with gonadotropin in ovulation induction in elderly patients with poor ovarian reserve: a multicenter, prospective, non-blind, randomized controlled clinical trial

Effectiveness and security of a novel ovarian stimulation protocol overlapping gonadotropin with letrozole in aged or women with diminshed ovarian reserve: a multi-center, prospective, non-blinded and randomized controlled clinical trial study

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000041408

Enrollment

Unknown

Registered

2020-12-25

Start date

2020-01-01

Completion date

Unknown

Last updated

2021-03-15

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

Conditions

Infertility

Interventions

Experiental group:letrozole combined with conventional dose of gonadotropin

Control group :GnRH antagonist protocol

Eligibility

Sex/Gender

Female

Age

22 Years to 44 Years

Inclusion criteria

Inclusion criteria: 1. Elderly people or people with low ovarian function reserve, including: (1) Very elderly patients: 40 years old <= 45 years old or (2) Patients with decreased ovarian reserve function: age < 40 years old, combined with AFC (2-9mm diameter follicles) < 5, or 0.1ng/ml <= AMH < 1.2ng/ml. 2. The subjects who plan to perform IVF or ICSI in the first four cycles; 3. The patients and their families who understand this clinical trial, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. The subjects of ovulation induction program in the experimental group who had conducted this study in the past. 2. Subjects with unilateral or bilateral fallopian tube effusion; 3. Patients with uterine diseases: uterine malformation (single horn uterus, double horn uterus, double uterus, mediastinal uterus); combined with adenomyosis, intrauterine adhesions, untreated endometrial polyps, submucous myoma; 4. Chromosome abnormality of one or both husband and wife; 5. Men with low spermatogenesis, non obstructive azoospermia or AZF gene microdeletion; 6. Subjects allergic to letrozole or GN; 7. Subjects with contraindications to assisted reproductive technology or pregnancy; 8. Subjects who can not be followed up for a long time or have poor compliance, or the researchers believe that there are any factors affecting the subjects' participation in the trial or evaluation of the results.

Design outcomes

Primary

Measure	Time frame
cumulative clinical pregnancy rate/COS;	—

Secondary

Measure	Time frame
Clinical pregnancy rate of fresh transplantation;clinical pregnancy rate of frozen transplantation;number of oocytes retrieved;rate of available embryo;Early abortion rate;live birth rate;cumulative liverate rate;	—

Countries

China

Contacts

Public ContactZhao Xiaomiao

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

zhaoxmiao@163.com+86 13922209605

Outcome results

None listed

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