Infertility Clinical Trial
Official title:
The Early Luteal Progesterone Profile in IVF Patients Triggered With hCG - a Pilot Study
Verified date | April 2017 |
Source | Vietnam National University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot-study will help characterize the serum progesterone profiles in IVF patients and correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 11, 2017 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 38 Years |
Eligibility |
Inclusion Criteria: - IVF patients who meet the following criteria: - Freeze all cycle after hCG trigger - Age 18 - 38 - Body Mass Index (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 Gonadotropin Releasing Hormone 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 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Vietnam National University | M? Ð?c Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in serum concentrations of progesterone | Blood samples are collected at ten points of time. | in 6 days after human chorionic gonadotropin injection | |
Primary | change in serum concentrations of luteinizing hormone | Blood samples are collected at ten points of time. | in 6 days after hCG injection | |
Primary | change in serum concentrations of estradiol | Blood samples are collected at ten points of time. | in 6 days after hCG injection | |
Primary | change in serum concentrations of hCG | Blood samples are collected at ten points of time. | in 6 days after hCG injection | |
Secondary | number of follicles larger than 11 millimeters | Number of follicles are counted on ultrasound image. | on the day of hCG injection |
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