Ciro University Kasr Alainy OBGYN Hospital
Cairo, Alquahira, 11835, Egypt
NCT Number: NCT06868576
The aim of this study is to compare the efficacy and safety of Progestin-Primed Ovarian Stimulation (PPOS) protocol versus the fixed GnRH antagonist protocol in expected normal responder patients undergoing intracytoplasmic sperm injection (ICSI) with frozen-thawed embryo transfer (FET). By evaluating key clinical outcomes, including ovarian response, embryological parameters, and pregnancy rates, this study seeks to determine the relative advantages and limitations of each protocol.
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Notify Me18 year–39 year
Female
Interventional
Phase 3
Cairo, Alquahira, 11835, Egypt
In this prospective, non-inferiority trial, we will compare the efficacy and safety of the GnRH antagonist and PPOS protocols in 328 infertile women undergoing ICSI in Kasr Al-Ainy IVF department, Cairo University, Egypt. Before the trial, investigators were required to provide all information related to the clinical trial, including the possible benefits and risks, other therapeutic choices and the right to withdraw, via a written consent. After being provided with sufficient time to decide whether to participate and the opportunity to ask questions, all participants were required to provide written informed consent before study inclusion.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dydrogesterone 20mg tablets daily in PPOS protocol in ovarian stimulation starting from day 2 or 3 of the menstrual cycle until the triggering day
This will be the conventional antagonist in ovarian stimulation given from day 6 of the menstrual cycle until the triggering day
Time frame: 7 weeks of gestational age
The presence of fetal pulsations by ultrasound at 7 weeks of gestational age
Time frame: before triggering injection and within 9 days after triggering injection
Time frame: within 1 day of ovum pick up
Time frame: within 1 day of ovum pick up
Time frame: 2-3 weeks after embryo transfer
Quantitative Beta chorinioic gonadotrophin (B-HCG) hormone levels in blood 2 to 3 weeks after embryo transfer.
Kasr El Aini Hospital
Other
Progestin-Primed Ovarian Stimulation Versus Gonadotrophin-Releasing Hormone Antagonist for Patients Undergoing Assisted Reproductive Technology: a Randomized Clinical Trial
Acronym: PPOS vs GnRH
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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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