The Letrozole Administration During Luteal Phase

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovarian Hyperstimulation Syndrome

Intervention / Treatment
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* Drug: Letrozole
* Drug: Polygeline
* Drug: Sodium Chloride
* Drug: dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: oocyte is more than or equal to 20; 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: letrozole<br>2.5mg/tablet(Jiangsu Hengrui Medicine Co., Ltd. products), orally taken 5mg once a day for 5 days | Drug: Letrozole<br>* used after oocyte retrieval<br>* Other names: Femara;|
| Other: Polygeline Injection<br>500ml and 0.9% Sodium Chloride Injection (250ml) with dexamethasone 1mg intravenous injection，once a day for 2 days | Drug: Polygeline<br>* used after oocyte retrieval<br>* Other names: polyegline;Drug: Sodium Chloride<br>* used after oocyte retrieval<br>* Other names: Natrum muriaticum;Drug: dexamethasone<br>* used after oocyte retrieval<br>* Other names: dexametona;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of early OHSS |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Letrozole, OHSS