Infertility Clinical Trial
Official title:
Subcutaneous Progesterone (Prolutex) Versus Vaginal Progesterone Capsules (Progeffik) for Endometrial Preparation in Fresh Donated Oocytes Recipients: a Randomised, Prospective, Single-blind, Pilot Study
Randomised, prospective, investigator-blinded, controlled, single-centre study to assess the impact on the ongoing pregnancy rate with the use of two progesterones with different administration routes, in recipients of fresh embryos from donor oocytes, undergoing endometrial preparation for fresh embryo transfer.
Exploratory study with a control group treated according to our Service's usual therapeutic
regimen for the transfer of embryos with donor oocytes.
The controlled ovarian stimulation protocol in oocyte donors is always calculated according
to the standard protocol at the Bernabeu Institute. Endometrial preparation will be carried
out following the standard protocol of the Bernabeu Institute as follows: the oestrogen will
be administered transdermally and patients with maintained ovarian function undergo medical
hypophysectomy with depot GnRH agonists administered in the mid-luteal phase of the previous
cycle.
On the day of oocyte retrieval, the patient will be randomised: Group A will be administered
subcutaneous progesterone 25 mg/day (Prolutex), and Group B will be administered vaginal
progesterone in capsules 200 mg/3 times a day (Progeffik).
The embryo transfer will be performed on day 5 of the embryo culture (Day +5). A biochemical
pregnancy test beta- hCG and the P4 analysis will be performed 14 days after oocyte
retrieval.
All the cycles will be monitored according to the Department's standard criteria, using
transvaginal ultrasound to assess embryonic development and endometrial thickness, as well
as analytical controls.
The study will be blinded to the investigator. The evaluating professionals will not know if
the subject has been administered vaginal progesterone or subcutaneous progesterone. The
medication will be delivered by a person who does not participate in the evaluations and who
is dedicated to group assignment, to data centralisation, and to delivering the medication.
The aim of this study is to determine if the ongoing pregnancy rate in patients undergoing a
fresh embryo transfer cycle with donor oocytes is affected by the progesterone
administration route.
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