Progesterone Supplementation Clinical Trial
Official title:
Optimal Length of Progesterone Supplementation Before the Transfer of Cryopreserved (Frozen)-Thawed Day 3 Embryos in an Artificial Cycle With Exogenous Estrogen and Progesterone
Cryopreserved-thawed embryos are often replaced in an artificial cycle, in which the
endometrium is prepared by exogenous estrogen and progesterone with or without the use of
GnRH agonist downregulation. The correct duration for exposure to progesterone is still not
well established. To date, there are no prospective randomized trials available, comparing
different durations of progesterone supplementation before the date of transfer, with regard
to treatment outcome (Nawroth).
In this trial, the investigators want to determine the optimal duration of progesterone
supplementation: 3 or 5 days before embryo transfer.
The purpose is to transfer the embryo during the 'window of implantation', what is defined as
the period during which the uterus is receptive for implantation of the free-lying
blastocyst. This has been a subject of debate since many years (Bourgain et al, 2007).
Succesful implantation requires a co-ordinated series of events allowing a timely dialogue
between a receptive endometrium and the intrusive blastocyst (Tabibzadeh, 1998). The period
of receptivity is thought to be 3 days in human (Rogers et al, 1989; Yoshinaga, 1988;
Psychoyos, 1993; Harper, 1992). It is suggested that blastocyst apposition begins about day
LH+6 and is completed by day LH+10 (Lessey, 2000).
A number of structural and functional endometrial changes have been suggested to play a role
in the implantation process: the formation of luminal epithelial pinopodes (Enders et al,
1973), expression of adhesion molecules and growth factors and cytokines (Lessey, 2000). Most
of them are related directly or indirectly to progesterone secretion and influence on the
endometrium.
In the Centre of Reproductive Medicine of the Brussels University Hospital, the investigators
start progesterone supplementation 5 days before the transfer of a day 3 embryo. In order to
mimic the natural cycle, since progesterone starts to rise 2 to 3 days before ovulation, due
to the LH-stimulated production by the peripheral granulosa cells (Speroff). In fresh
IVF-cycles, progesterone is started from the day of oocyte retrieval. HCG administration in
fresh cycles will lead to an increase in progesterone levels and therefore, endometrium will
progress quickly, compared with frozen-thawed cycles which are hormone supplemented
(Nawroth).
In other centres, progesterone supplementation is generally started 3 days before the embryo
transfer.
In this trial, the investigators want to determine the optimal duration of progesterone
supplementation: 3 or 5 days before embryo transfer.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04837768 -
Effect of Intramuscular Progesterone Supplementation on Clinical and Ongoing Pregnancy Rates in Patients With Low Serum Progesterone Levels on the Day of Embryo Transfer in Artificial Frozen Cycles
|
N/A |