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NCT05758064
How to Rescue Hormonal Replacement Frozen Embryo Transfer Cycle With Low Serum Progesterone? A Randomized Control Trial.
Phase 2/Phase 3 trial testing Duphaston in Hormonal Replacement Frozen Embryo Transfer Cycle in 120 participants. Status unknown.
1 December 2023
Quick facts
| Lead sponsor | El Shatby University Hospital for Obstetrics and Gynecology |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 January 2023 |
| Primary completion | 1 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 2 locations across Egypt |
Drugs / interventions tested
Conditions studied
- Hormonal Replacement Frozen Embryo Transfer Cycle — all drugs for Hormonal Replacement Frozen Embryo Transfer Cycle →
Sponsor
El Shatby University Hospital for Obstetrics and Gynecology
Who can join
Adults 18 to 40, female only, with Hormonal Replacement Frozen Embryo Transfer Cycle. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Clinical pregnancy rate
Time frame: at the 6 th weeks of pregnancy
percentage of cases in which observation of a gestational sac with fetal heart beat by transvaginal ultrasound at 6 weeks of pregnancy
Sponsor's own description
Frozen embryo transfer (FET) is increasingly adopted strategy in modern IVF. Among the many factors that have contributed to such change, the pursuit of an ovarian hyperstimulation syndrome free clinic has been strongly required. Improvements in the vitrification and warming processes and the excellent cryo-survival rates have turned FET in our main tool for preventing this complication. Moreover, a freeze all strategy has proven to provide excellent or even better pregnancy rates (PRs), not only in high but also in normal responders. While ART have rapidly evolved in the areas of embryo culture, vitrification and understanding of the embryo development, little progress has been achieved regarding endometrial preparation for FET. Undoubtedly, correct implantation requires a good quality embryo and a suitable decidualized endometrium. Artificial cycles require hormone replacement treatment (HRT) with estradiol and progesterone (P4). However, there is not a single standardized treatment described for optimal endometrial preparation and no protocol has proven superiority in terms of reproductive outcomes.(5, 6) Although artificial preparation is the most convenient method to schedule FET cycles, recent reports have highlighted a potentially detrimental effect of low P4 levels prior to FET on miscarriage and live birth rates (LBRs). These results have been observed both in homologous and oocyte recipient FET cycles(7, 8), but also in FET cycles of embryos that had undergone PGT for aneuploidies (PGT-A).(9) Additional P4 supplementation may be a way to improve reproductive outcomes in these patients. Our open labelled randomized control study aims to investigate whether patients with low serum P4 levels the day before FET under standard HRT can benefit in terms of clinical and ongoing pregnancy and implantation rates from an individualized luteal phase support consisting in the addition of oral dydrogesterone supplementation or daily subcutaneous P4 injection.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other trials of Duphaston
Trials testing the same drug.
- NCT05521828 — Luteal Phase Ovarian Stimulation With Follitropin Delta and Dydrogesterone · NA · unknown
- NCT04537078 — Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders · Phase 3 · completed
- NCT03680053 — Comparison of the Live Birth Rate Between the PPOS and the GnRH Antagonist Protocol in Patients Undergoing IVF · NA · terminated
- NCT03858049 — Efficacy and Safety of Crinone Versus Combination Medication (ACCESS) · Phase 4 · terminated
Other El Shatby University Hospital for Obstetrics and Gynecology trials
Trials by the same sponsor.
- NCT06812559 — Progesterone Primed Ovarian Stimulation Versus GnRH Antagonist Protocols in Women With Polycystic Ovarian Syndrome · completed
- NCT06616441 — The Effect of Intraperitoneal Instillation of Bupivacaine on Postoperative Pain After Surgical Laparoscopy · Phase 3 · completed
- NCT04537078 — Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05758064 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by El Shatby University Hospital for Obstetrics and Gynecology
- Last refreshed: 4 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05758064.
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