NCT02686151

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The Affiliated Hospital of Inner Mongolia Medical University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Hyperstimulation Syndrome

Interventions

Type	Name	Description
DRUG	Letrozole	used after oocyte retrieval
DRUG	Polygeline	used after oocyte retrieval
DRUG	Sodium Chloride	used after oocyte retrieval
DRUG	dexamethasone	used after oocyte retrieval

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-03-01
• Completion: 2024-12-01
• First posted: 2016-02-19
• Last updated: 2023-07-20

Locations

1 site across 1 country: China