Phase 3
N=90
Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders
Infertility, Female
Bottom Line
View on ClinicalTrials.gov: NCT04537078 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: the Number of M2 Oocytes Retrieved — 6; 4.5 oocytes — p=0.254
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Duphaston (Drug); Gonadotropin (Drug); Cetrotide Injectable Product (Drug); Decapeptyl (Drug); Chorionic Gonadotropin (Drug); Combined Oral Contraceptive (Drug); Cyclo-Progynova (Drug); progesterone (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- El Shatby University Hospital for Obstetrics and Gynecology
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Number of M2 Oocytes Retrieved |
6; 4.5 | 0.254 |
| PRIMARY the Fertilization Rate |
71.43; 80.91 | 0.219 |
| PRIMARY the Resultant Embryos Number |
4; 3 | 0.269 |
| PRIMARY the Implantation Rate |
50; 50 | 0.072 |
| PRIMARY the Clinical Pregnancy Rate. |
7; 8 | 1 |
| SECONDARY the Difference in the Ongoing Pregnancy Rate in Both Protocols. |
6; 5 | 0.720 |
| SECONDARY the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Total Days of Controlled Ovarian Hyperstimulation |
10; 12 | 0.002 sig |
| SECONDARY the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Total Dosage of Gonadotropins Used in the Controlled Ovarian Hyperstimulation |
3000; 3600 | 0.007 sig |
| SECONDARY the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Number of M2 Oocytes Retrieved |
2; 4 | 0.001 sig |
| SECONDARY the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Fertilization Rate. |
66.67; 100 | 0.04 sig |
| SECONDARY the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Resultant Embryos Number |
1; 3 | <0.001 sig |
| SECONDARY Assessing the Difference Between the Follicular Phase of the Progestin Primed Double Stimulation Protocol and the First Round of the Conventional GnRH Antagonist Protocol Regarding the Number of M2 Oocytes Retrieved . |
2; 2 | 0.851 |
| SECONDARY Assessing the Difference Between the Follicular Phase of the Progestin Primed Double Stimulation Protocol and the First Round of the Conventional GnRH Antagonist Protocol Regarding the Fertilization Rate. |
66.67; 91.67 | 0.304 |
| SECONDARY Assessing the Difference Between the Follicular Phase of the Progestin Primed Double Stimulation Protocol and the First Round of the Conventional GnRH Antagonist Protocol Regarding the Resultant Embryos Number. |
1.66; 1.69 | 0.486 |
Summary
The worldwide prevalence of primary and secondary infertility is estimated at ~2% and 10.5%, respectively, among women aged 20-44 years and attempting to conceive. Poor ovarian responders (PORs) involve 9-24% of patients undergoing in-vitro fertilization (IVF). proper tailoring of the ovarian stimulation protocol in order to maximize the number of oocytes collected represents a crucial step for them to eventually conceive.
Recent evidence indicates that in the same menstrual cycle, there are multiple follicular recruitment waves. This coincides with the theory that folliculogenesis occurs in a wave-like fashion. Thus, within a single menstrual cycle, there can theoretically be multiple opportunities for a clinician to collect oocytes, as opposed to the conventional single cohort of antral follicles during the follicular phase.
Utilizing this concept, clinicians have been attempting to retrieve oocytes from poor responders using both the follicular-phase stimulation (FPS) and the luteal-phase stimulation (LPS) protocols to increase the number of oocytes collected shorter within shorter period of time. By increasing the number of the retrieved oocytes collected, a better clinical can be assured since there is a clear relationship between the number of oocytes collected and live birth rates across all female age groups.
which protocol is the most effective remains controversial and the efficacy of PPOS in POR compared with that of conventional protocols is unclear.
Eligibility Criteria
Inclusion Criteria
poor ovarian responders patients defined by Bologna criteria
Exclusion Criteria
- Male factor infertility due to azoospermia.
- Patients with uncorrected uterine pathology.
- Patients with the diagnosis of severe endometriosis.
- Patients with BMI over 35.
Data sourced from ClinicalTrials.gov (NCT04537078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.