in Vitro Fertilisation Clinical Trial
Official title:
Reproductive Outcome of IVF Treatment in Relation to the Early Luteal Phase Trajectory of Progesterone and Other Corpus Luteum Related Hormones
Verified date | June 2023 |
Source | M? Ð?c Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
It has recently been demonstrated that a bolus trigger of hCG induces various unphysiological conditions in the early luteal phase that may negatively affect an IVF treatment cycle's reproductive outcome. The bolus trigger of hCG differ from the natural cycle in mainly three different ways: 1) The timing of the initiation of hCG and progesterone rise is much faster after an hCG trigger than in the natural menstrual cycle 2) the maximal concentrations of hCG and progesterone considerably exceed those naturally observed 3) The timing of the peak progesterone concentration following an hCG trigger is advanced several days compared to the natural cycle. These characteristics may affect the reproductive outcome in treatment cycles but are not explored. The aim of this study is to monitor whether specific trajectories of important luteal phase hormones may predict the chances of conception?
Status | Completed |
Enrollment | 95 |
Est. completion date | January 31, 2023 |
Est. primary completion date | August 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 38 Years |
Eligibility | Inclusion Criteria: - Age 18 - 38 - BMI < 28kg/m2 - Normal ovarian reserve (anti-Müllerian hormone level above 8.93 pmol/L or an antral follicle count of 6 or above within two months prior to stimulation) - Having 4 to 19 follicles with a diameter of 14mm or above on the day of hCG triggering - Receiving a standard GnRH-antagonist protocol for ovarian stimulation - Having indication for fresh embryo transfer - Willingness to participate in the study, and to disclose any medical conditions to the investigator. The patient must be prepared and willing to comply with the requirements of the protocol. - The patient should after appropriate oral and written consent understand the study and be informed that she may withdraw consent at any time without prejudice to future medical care. Exclusion Criteria: - Previous poor ovarian response (= 3 follicles) after appropriate FSH stimulation - Hyper-response defined as =20 follicles =14 mm on the day of trigger - Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B, Sexually Transmitted Diseases and simultaneous participation in an interventional clinical trial. |
Country | Name | City | State |
---|---|---|---|
Vietnam | M? Ð?c Hospital | Ho Chi Minh City | Tan Binh |
Lead Sponsor | Collaborator |
---|---|
M? Ð?c Hospital |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Live birth rate in relation to the trajectory of progesterone in the early luteal phase | Live birth was defined as the birth of at least one newborn after 24 weeks' gestation that exhibited any sign of life (twins were a single count). | After 24 weeks of gestation | |
Primary | Live birth rate in relation to the trajectory of 17-OH progesterone in the early luteal phase | Live birth was defined as the birth of at least one newborn after 24 weeks' gestation that exhibited any sign of life (twins were a single count). | After 24 weeks of gestation | |
Primary | Live birth rate in relation to the trajectory of hCG in the early luteal phase | Live birth was defined as the birth of at least one newborn after 24 weeks' gestation that exhibited any sign of life (twins were a single count). | After 24 weeks of gestation | |
Secondary | The clinical pregnancy rate in relation to the trajectory of progesterone in the early luteal phase | Pregnancy with at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity | At 5 weeks after embryo placement | |
Secondary | The ongoing pregnancy rate in relation to the trajectory of progesterone in the early luteal phase | Pregnancy with detectable heart rate at 12 weeks' gestation or beyond | At 10 weeks or beyond after the embryo placement | |
Secondary | The clinical pregnancy rate in relation to the trajectory of 17-OH progesterone in the early luteal phase | Pregnancy with at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity | At 5 weeks after embryo placement | |
Secondary | The ongoing pregnancy rate in relation to the trajectory of 17-OH progesterone in the early luteal phase | Pregnancy with detectable heart rate at 12 weeks' gestation or beyond | At 10 weeks or beyond after the embryo placement | |
Secondary | The miscarriage rate in relation to the trajectory of progesterone in the early luteal phase | Pregnancy loss before 12 completed weeks of gestational age | Before 12 weeks of gestation | |
Secondary | The miscarriage rate in relation to the trajectory of 17-OH progesterone in the early luteal phase | Pregnancy loss before 12 completed weeks of gestational age | Before 12 weeks of gestation | |
Secondary | Live birth rate in relation to the trajectory of inhibin A in the early luteal phase | Will be reported in a separate paper | After 24 weeks of gestation |
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