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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04693624
Other study ID # 18/20/DD-BV
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 12, 2021
Est. completion date January 31, 2023

Study information

Verified date June 2023
Source M? Ð?c Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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?


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hormonal levels
A total of ten (10) blood samples (2ml/each) will be collected during the study for subsequent analysis of progesterone, hCG, inhibin-A, and 17-OH-progesterone: Day of triggering (before the injection of hCG, appx. 6 pm) Twelve (12 hours) after hCG injection (appx. at 6 am) Twenty-four (24) hours after hCG injection (appx. at 6 pm) Thirty-six (36) hours after hCG injection (appx. at 8 am, 2 hours after OPU) One (1) day after OPU (60h after hCG) (appx. at 6 am) Two (2) days after OPU (84h after hCG) (appx. at 6 am) Three (3) days after OPU 108h after hCG) (appx. at 6 am) Four (4) days after OPU (132h after hCG) (appx. at 6 am) Five (5) days after OPU (156h after hCG) (appx. at 6 am) Six (6) days after OPU (180h after hCG) (appx. at 6 am)

Locations

Country Name City State
Vietnam M? Ð?c Hospital Ho Chi Minh City Tan Binh

Sponsors (1)

Lead Sponsor Collaborator
M? Ð?c Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

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
See also
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