IVI Valencia
Valencia, 46015, Spain
NCT Number: NCT03300960
The purpose of this study is to determine whether Medroxyprogesterone Acetate (MPA) administration in follicular phase prevents premature luteinization with equal efficiency as GnRH antagonists and otains similar clinical results in oocyte donation.
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Notify Me18 year–35 year
Female
Interventional
Phase 3
Valencia, 46015, Spain
Within the new guidelines for stimulation, the use of oral progesterone in follicular phase allows GnRH analogue administration, resulting in greater comfort for patients as well as a reduction in cost. Obtained results are similar to those from conventional protocols in terms of: early luteinization, number of oocytes, embryos number and rate of implantation and gestation or appearance of congenital malformations. Another advantage is the lower incidence of OHSS (Ovarian Hyperstimulation Syndrome).
From a scientific point of view, it would allow a better understanding of folliculogenesis, of progesterone mechanism of action on blocking LH secretion and its effect on ovarian and later embryonic level.
From a clinical point of view, it would simplify COS (Controlled Ovarian Stimulation) by reducing the number of medication administered subcutaneously and their possible side effects on both systemic and local levels. It would be of special interest in 2 groups of patients, for example, oocyte donors and patients undergoing preservation of fertility. To date, there is a lack of studies along these lines.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
i. With no relevant personal or family medical history ii. Signing of Informed Consent iii. From a medical point of view:
Exclusion criteria
One 10 mg tablet of MPA (Medroxyprogesterone acetate) is administered every 24 hours from the onset of Controlled Ovarian Stimulation (COS), until the day of triggering.
One ampoule of Ganirelix (GnRH antagonist) a day once diameter of follicles are 14 mm diameter on average until triggering.
Time frame: 36 hours: from triggering until Oocyte retrieval
Compare oocytes in COS cycles between two groups: using GnRH antagonist versus PMA for avoiding premature luteinization.
Instituto Valenciano de Infertilidad, IVI VALENCIA
Other
Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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