The Letrozole Administration During Luteal Phase

Inner Mongolia Medical University

Status and phase: Not yet enrolling; Phase 3

Conditions: Ovarian Hyperstimulation Syndrome

Treatments: Drug: Sodium Chloride; Drug: Letrozole; Drug: Polygeline; Drug: dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02686151

Bhsu

Details and patient eligibility

About

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.

Full description

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.

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.

Reproductive hormone levels:

1, 4, 7, days after taken letrozole, and the supernatant was collected for serum reproductive hormone test.

Enrollment: 50 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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;

3. follicle puncture is larger than or equal to number 20.

Exclusion criteria

Allergic to the letrozole or polygeline.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

letrozole

Active Comparator group

Description:

2.5mg/tablet(Jiangsu Hengrui Medicine Co., Ltd. products), orally taken 5mg once a day for 5 days

Treatment:

Drug: Letrozole

Polygeline Injection

Other group

Description:

500ml and 0.9% Sodium Chloride Injection (250ml) with dexamethasone 1mg intravenous injection，once a day for 2 days

Treatment:

Drug: dexamethasone

Drug: Polygeline

Drug: Sodium Chloride