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Relaxin Measurement in Different Endometrial Preparation Approaches for Frozen Embryo Transfer

A

ART Fertility Clinics LLC

Status

Enrolling

Conditions

Frozen Embryo Transfer

Treatments

Drug: Exposure to progesterone or HRT medication

Study type

Observational

Funder types

Other

Identifiers

NCT06526520
2406-ABU-007-BL

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 estimated patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

5 participants in 3 patient groups

Natural cycle
Description:
Monitoring of a natural cycle
natural proliferative phase cycle
Description:
Monitoring of a natural proliferative phase cycle
Treatment:
Drug: Exposure to progesterone or HRT medication
Hormonal replacement cycle
Description:
Monitoring of a hormonal replacement cycle
Treatment:
Drug: Exposure to progesterone or HRT medication

Trial contacts and locations

1

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Central trial contact

Barbara Lawrenz, M.D. PhD; Jonalyn Edades, MBA

Data sourced from clinicaltrials.gov

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