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Comparison of live birth rates with letrozole plus gonadotropin versus gonadotropin plus intrauterine insemination (IUI) in patients with unexplained infertility: a multicenter, prospective, randomized controlled clinical study

Comparison of live birth rates with letrozole plus gonadotropin versus gonadotropin plus intrauterine insemination (IUI) in patients with unexplained infertility: a multicenter, prospective, randomized controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050450
Enrollment
Unknown
Registered
2021-08-27
Start date
2021-08-31
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Unexplained Infertility

Interventions

Group A: Letrozole + gonadotropin
Group B:Gonadotropin

Sponsors

The First Affiliated Hospital of Nanjing Medical University / Jiangsu Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 37 Years

Inclusion criteria

Inclusion criteria: 1. Aged 20-37 years; 2. Normal ovulation (including BBT biphasic or B-ultrasound) or regular menstrual cycle (21-35 days); 3. Bilateral fallopian tubes are unobstructed (confirmed by lipiodol imaging or ultrasound salpingography or laparoscopy, only one side is unobstructed but not unobstructed); 4. The man's semen is routinely normal; 5. Both husband and wife agree to conduct outpatient ovulation induction + artificial insemination; 6. No artificial insemination before; 1 year without contraception and no pregnancy, over 35 years old without contraception but not pregnant for 6 months.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with abnormal uterine cavity morphology (confirmed by three-dimensional B-ultrasound or hysteroscopy), including uterine malformations (mediastinal uterus, unicornuate uterus, double uterus), submucosal uterine fibroids or intrauterine adhesions; 2. Other diseases that may cause infertility, such as hyperprolactinemia, uncontrolled thyroid dysfunction, polycystic ovary syndrome, ovarian insufficiency (AMH30kg/m^2; 10. IUI contraindications to TCT or HPV results (report within 1 year).

Design outcomes

Primary

MeasureTime frame
Live birth rate;The incidence of ovarian hyperstimulation syndrome;

Secondary

MeasureTime frame
Clinical pregnancy rate;Multiple follicular rate;Incidence of twins and multiple births;Pregnancy loss rate;Ectopic pregnancy rate;Pregnancy and perinatal complications;

Countries

China

Contacts

Public ContactLiu Jinyong, Wang Jing

The First Affiliated Hospital of Nanjing Medical University / Jiangsu Provincial Hospital

ljyfree1978@163.com+86 13913919115

Outcome results

None listed

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