Relaxin Measurement in Different Endometrial Preparation Approaches for Frozen Embryo Transfer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- ART Fertility Clinics LLC
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Relaxin measurement
Study Overview
Brief Summary
To investigate the levels of Relaxin in different types of endometrial preparation for a frozen embryo transfer cycle. Up to now it is unclear, whether ovulation with a functional corpus luteum (CL) will be present in a natural proliferative phase (NPP) endometrial preparation approach.
Detailed Description
The last years have seen a distinct shift from fresh (fresh ET) to frozen embryo transfer (FET) cycles. Furthermore it became obvious, that the endometrial preparation approach has a significant impact on the course of the pregnancy and that a HRT endometrial preparation approach is associated with a higher risk for bleeding and miscarriages in early pregnancy and for the development of pregnancy induced hypertension and pre-eclampsia later in pregnancy.
These conditions are attributed to the absence of a CL in the HRT approach. Lately a new endometrial preparation approach is discussed and performed, the so called natural proliferative phase protocol, in which the follicle growth is monitored and when the lining is deemed to have a sufficient thickness and the triple lining pattern, exogeneous progesterone is started to induce secretory transformation before spontaneous ovulation. Despite some studies showing, that exogeneous progesterone administration might induce ovulation, it is not clear whether there will be a CL, producing Relaxin, in the NPP approach.
Study Design
- Study Type
- Observational
- Observational Model
- Case Crossover
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •regular menstrual cycles
Exclusion Criteria
- •abnormal findings of the ovaries (e.g endometriosis)
- •Intake of any hormones within 3 months of study start
- •desire to become pregnant
Arms & Interventions
natural proliferative phase cycle
Monitoring of a natural proliferative phase cycle
Intervention: Exposure to progesterone or HRT medication (Drug)
Hormonal replacement cycle
Monitoring of a hormonal replacement cycle
Intervention: Exposure to progesterone or HRT medication (Drug)
Outcomes
Primary Outcomes
Relaxin measurement
Time Frame: 4 to 6 months
Measurement of Relaxin in the different types of frozen embryo transfer
Secondary Outcomes
No secondary outcomes reported
