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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03174691
Date of registration: 30/05/2017
Prospective Registration: Yes
Primary sponsor: Vietnam National University
Public title: Early Luteal Progesterone Profile in IVF Patients Triggered With hCG
Scientific title: The Early Luteal Progesterone Profile in IVF Patients Triggered With hCG
Date of first enrolment: June 7, 2017
Target sample size: 161
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03174691
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Vietnam
Contacts
Name:     Tuong M Ho, MD
Address: 
Telephone:
Email:
Affiliation:  Research Center for Genetics and Reproductive Health Ho Chi Minh, Ho Chi Minh Vietnam
Key inclusion & exclusion criteria

Inclusion Criteria:

- Freeze all cycle after hCG trigger

- Age 18 - 38

- BMI < 28kg/m2

- Normal ovarian reserve, defined by Anti-Mullerian Hormone (AMH) > 1.25 ng/ml or Antral
Follicle Count (AFC) = 6 measured within two months prior to stimulation start

- Receiving gonadotrophin releasing hormone (GnRH) antagonist co-treatment during
ovarian stimulation

- Agreement to participate in the study, and to disclose any medical events to the
investigator. The subject must be willing and able to comply with the protocol
requirements for the duration of the study.

- Have given written informed consent with the understanding that the subject may
withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

- Previous poor response (= 3 oocytes) after high dose follicle stimulating hormone
(FSH) stimulation

- Hyper-response defined as >20 follicles = 14 mm

- Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis
B and Sexually Transmitted Diseases Simultaneous participation in an interventional
clinical trial.



Age minimum: 18 Years
Age maximum: 42 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Infertility
Intervention(s)
Diagnostic Test: Blood collection
Primary Outcome(s)
Serum concentrations of progesterone,17-Hydroxyprogesterone, LH, E2, and hCG during early luteal phase [Time Frame: In 6 days after human chorionic gonadotropin injection]
Secondary Outcome(s)
Number of follicles = 11 mm luteal phase [Time Frame: On the day of hCG injection]
Secondary ID(s)
NCKH/CGRH-09-2017
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
M? Ð?c Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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