The Letrozole Administration During Luteal Phase

July 18, 2023 updated by: The Affiliated Hospital of Inner Mongolia Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Inner Mongolia, China
        • The Affiliated Hospital of Inner Mongolia Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of early OHSS
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Inner Mongolia Medical University

Investigators

  • Principal Investigator: Yu Wang, PhD, Inner Mongolia Medical University Affiliated Hospital
  • Principal Investigator: Xiujuan Chen, MD, Inner Mongolia Medical University Affiliated Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

February 15, 2016

First Posted (Estimated)

February 19, 2016

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHSU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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