Clinical trial NCT02686151: The Letrozole Administration During Luteal Phase
Official title: The Randomized Clinical Trials of Letrozole Administration During Luteal Phase in Patients Who Have the Risk of Ovarian Hyperstimulation Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: Letrozole
OHSS
Lead sponsor: The Affiliated Hospital of Inner Mongolia Medical University
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of early OHSS
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Inner Mongolia
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
Study officials:
affiliation: Inner Mongolia Medical University affiliated Hospital
name: Yu Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inner Mongolia Medical University affiliated Hospital
name: Xiujuan Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: He Q, Xu J, Cui S, Li H, Zhang C. [Relationship between letrozole administration during the luteal phase after oocyte retrieval and the early-stage ovarian hyperstimulation syndrome oocurrence]. Zhonghua Fu Chan Ke Za Zhi. 2014 Dec;49(12):909-13. Chinese.
citation: Wang YQ, Yang J, Xu WM, Xie QZ, Yan WJ, Yin TL, Cheng D, Xiao ZN, Li J. [Luteal letrozole administration decreases serum estrogen level but not the risk of ovarian hyperstimulation syndrome]. Beijing Da Xue Xue Bao Yi Xue Ban. 2013 Dec 18;45(6):869-72. Chinese.
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