Relaxin Measurement in Different Endometrial Preparation Approaches for Frozen Embryo Transfer
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Barbara Lawrenz, M.D. PhD
- Phone Number: 800 337845489
- Email: barbara.lawrenz@artfertilityclinics.com
Study Contact Backup
- Name: Jonalyn Edades, MBA
- Phone Number: 800 337845489
- Email: jonalyn.edades@artfertilityclinics.com
Study Locations
-
-
Abu Dhabi Emirate
-
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 60202
- Recruiting
- ART Fertiltiy Clinic
-
Principal Investigator:
- Barbara Lawrenz, PhD
-
Contact:
- Barbara Lawrenz
- Phone Number: 00971526500757
- Email: barbara.lawrenz@artfertilityclinics.com
-
Contact:
- Jonalyn Edades, MBA
- Email: barbara.lawrenz@web.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Natural cycle
Monitoring of a natural cycle
|
|
|
natural proliferative phase cycle
Monitoring of a natural proliferative phase cycle
|
to add either progesterone only in the NPP protocol or E2 and progesterone in a HRT protocol
|
|
Hormonal replacement cycle
Monitoring of a hormonal replacement cycle
|
to add either progesterone only in the NPP protocol or E2 and progesterone in a HRT protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relaxin measurement
Time Frame: 4 to 6 months
|
Measurement of Relaxin in the different types of frozen embryo transfer
|
4 to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barbara Lawrenz, PhD, ART Fertility Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2406-ABU-007-BL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.