The Letrozole Administration During Luteal Phase

I

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

Trial contacts and locations

1

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Central trial contact

Yu Wang, PhD

Data sourced from clinicaltrials.gov

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