Skip to content

The Letrozole Administration During Luteal Phase

The Randomized Clinical Trials of Letrozole Administration During Luteal Phase in Patients Who Have the Risk of Ovarian Hyperstimulation Syndrome

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02686151
Enrollment
50
Registered
2016-02-19
Start date
2023-12-31
Completion date
2024-12-31
Last updated
2023-07-20

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

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

Letrozole, OHSS

Brief summary

To investigate the effect of letrozole in patients who have high risk of ovarian hyperstimulation syndrome (OHSS) after oocyte retrieval, the incidence of OHSS were calculated between letrozole group and supporting treatment group.

Detailed description

1. Object: Infertility patients who frozen all embryos due to the risk of OHSS were randomized allocated to letrozole or polygeline injection group. Inclusion criteria meet one of the following conditions: (1) oocyte is more than or equal to 20; (2) human chorionic gonadotropin (hCG) injection on serum estradiol levels greater than or equal to 5000 pmol/L; (3) on the day of oocyte unilateral or bilateral ovarian diameter greater than or equal to 10 cm (4) follicle puncture is larger than or equal to number 20. After the informed consent was signed, letrozole or polygeline injection was randomized allocated after oocyte retrieval. OHSS was determined according to Golan diagnosis standards. 2. Clinical data: Including age, infertility duration, body mass index (BMI), basic follicle-stimulating hormone (FSH) and luteinizing hormone (LH), antral follicle number (AFC), Gn dosage, estradiol level on hCG injection day, the number of oocytes, the number of embryos, early onset OHSS incidence, and the existence of ascites. 3. Reproductive hormone levels: 1, 4, 7, days after taken letrozole, and the supernatant was collected for serum reproductive hormone test.

Interventions

DRUGLetrozole

used after oocyte retrieval

DRUGPolygeline

used after oocyte retrieval

DRUGSodium Chloride

used after oocyte retrieval

DRUGdexamethasone

used after oocyte retrieval

Sponsors

The Affiliated Hospital of Inner Mongolia Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

1. oocyte is more than or equal to 20; 2. hCG injection on serum estradiol levels greater than or equal to 5000 pmol/L; 3. on the day of oocyte unilateral or bilateral ovarian diameter greater than or equal to 10 cm; 4\. follicle puncture is larger than or equal to number 20.

Exclusion criteria

Allergic to the letrozole or polygeline.

Design outcomes

Primary

MeasureTime frame
The incidence of early OHSSone year

Countries

China

Contacts

Primary ContactYu Wang, PhD
wuai1544@163.com+86-18604718958

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026