Trial · NCT04537078
Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders
NCT04537078, Phase 3, Completed, El Shatby University Hospital for Obstetrics and Gynecology; results first posted 2022-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders. Trials, record NCT04537078. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04537078
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders
- NCT number
- NCT04537078
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 90 participants, actual
- Lead sponsor
- El Shatby University Hospital for Obstetrics and Gynecology
- Conditions
- Infertility, Female
- Interventions
- Duphaston, Gonadotropin, Cetrotide Injectable Product, Decapeptyl, Chorionic Gonadotropin, Combined Oral Contraceptive, Cyclo-Progynova, progesterone
- First posted
- 2020-09-03
- Last updated
- 2022-02-17
- Results first posted
- 2022-02-17
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | the Number of M2 Oocytes Retrieved | 1-2 hours after oocyte retrieval | it is the number of M2 oocytes retrieved that were being assessed after denudation |
| Primary | the Fertilization Rate | 16 to 20 hours after microinjection of the oocytes with the sperms | percentage transformation of micro injected oocytes into two pronuclei. it is done 16 to 20 hours after microinjection of the oocytes by the sperms |
| Primary | the Resultant Embryos Number | the embryos number counted day 3 or 4or 5 after fertilization | it is the resultant embryos number counted day 3 or 4 or 5 after fertilization |
| Primary | the Implantation Rate | at the 6 th week of pregnancy | it is calculated as the number of intrauterine gestational sacs observed by transvaginal ultrasonography divided by the number of transferred embryos at the 6 th week of pregnancy and then multiplied by 100 |
| Primary | the Clinical Pregnancy Rate. | 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 |
| Secondary | the Difference in the Ongoing Pregnancy Rate in Both Protocols. | At the 20 th week of gestation | Assessing the difference in the ongoing pregnancy rate when the pregnancy had completed ≥20 weeks of gestation |
| 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 | From the first day of ovarian stimulation till the last day of ovarian stimulation in each phase ,the follicular and the luteal, of stimulation | the total number of days of the controlled ovarian hyperstimulation in both follicular and luteal phase of the progestin primed double stimulation protocol are studied so as to asses the difference between the two phases, the follicular phase and the luteal phase of the progestin primed double stimulation protocol |
| 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 | From the first day of ovarian stimulation till the last day of ovarian stimulation in each phase ,the follicular and the luteal, of stimulation | Assessing 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 so as to the difference between the two phases |
| 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 | 1-2 hours after oocyte retrieval | it is the number of M2 oocytes retrieved that were being assessed after denudation so as to the difference between the results between the two phases, the follicular phase and the luteal phase of the progestin primed double stimulation protocol |
| Secondary | the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Fertilization Rate. | 16 to 20 hours after microinjection of the oocytes with the sperms | percentage of transformation of micro injected oocytes into two pronuclei at 16 -20 hours after microinjection of the oocytes by the sperms so as to the difference between the results between the two phases, the follicular phase and the luteal phase of the progestin primed double stimulation protocol |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | the Number of M2 Oocytes Retrieved | 1-2 hours after oocyte retrieval | oocytes | MEDIAN | |
| PRIMARY | the Fertilization Rate | 16 to 20 hours after microinjection of the oocytes with the sperms | percentage of transformation | MEDIAN | |
| PRIMARY | the Resultant Embryos Number | the embryos number counted day 3 or 4or 5 after fertilization | number of embryos | MEDIAN | |
| PRIMARY | the Implantation Rate | at the 6 th week of pregnancy | percentage | MEDIAN | |
| PRIMARY | the Clinical Pregnancy Rate. | at the 6 th weeks of pregnancy | percentage of participants | NUMBER | |
| SECONDARY | the Difference in the Ongoing Pregnancy Rate in Both Protocols. | At the 20 th week of gestation | percentage of participants | NUMBER | |
| 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 | From the first day of ovarian stimulation till the last day of ovarian stimulation in each phase ,the follicular and the luteal, of stimulation | the progestin primed dual stimulation group are subdivided into the follicular phase stimulation and the luteal phase stimulation so as to study the difference between both phases | number of days | MEDIAN |
| 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 | From the first day of ovarian stimulation till the last day of ovarian stimulation in each phase ,the follicular and the luteal, of stimulation | the progestin primed dual stimulation group are subdivided into the follicular phase stimulation and the luteal phase stimulation so as to study the difference between both phases | IU | MEDIAN |
| 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 | 1-2 hours after oocyte retrieval | the progestin primed dual stimulation group are subdivided into the follicular phase stimulation and the luteal phase stimulation so as to study the difference between both phases | number of oocytes | MEDIAN |
| SECONDARY | the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Fertilization Rate. | 16 to 20 hours after microinjection of the oocytes with the sperms | the progestin primed dual stimulation group are subdivided into the follicular phase stimulation and the luteal phase stimulation so as to study the difference between both phases | percentage | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| the Number of M2 Oocytes Retrieved | the Progestin Primed Double Stimulation Group | 6 | Inter-Quartile Range 3 to 7 | oocytes | |
| the Number of M2 Oocytes Retrieved | the Flexible GnRh Antagonist Group | 4.5 | Inter-Quartile Range 3 to 8 | oocytes | |
| the Fertilization Rate | the Progestin Primed Double Stimulation Group | 71.43 | Inter-Quartile Range 66.67 to 100 | percentage of transformation | |
| the Fertilization Rate | the Flexible GnRh Antagonist Group | 80.91 | Inter-Quartile Range 66.67 to 100 | percentage of transformation | |
| the Resultant Embryos Number | the Progestin Primed Double Stimulation Group | 4 | Inter-Quartile Range 3 to 5 | number of embryos | |
| the Resultant Embryos Number | the Flexible GnRh Antagonist Group | 3 | Inter-Quartile Range 2 to 6 | number of embryos | |
| the Implantation Rate | the Progestin Primed Double Stimulation Group | 50 | Inter-Quartile Range 50 to 100 | percentage | |
| the Implantation Rate | the Flexible GnRh Antagonist Group | 50 | Inter-Quartile Range 33.33 to 50 | percentage | |
| the Clinical Pregnancy Rate. | the Progestin Primed Double Stimulation Group | 7 | percentage of participants | ||
| the Clinical Pregnancy Rate. | the Flexible GnRh Antagonist Group | 8 | percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | the Progestin Primed Double Stimulation Group | 45 | |
| Overall Study | STARTED | the Flexible GnRh Antagonist | 45 | |
| Overall Study | COMPLETED | the Progestin Primed Double Stimulation Group | 41 | |
| Overall Study | COMPLETED | the Flexible GnRh Antagonist | 42 | |
| Overall Study | NOT COMPLETED | the Progestin Primed Double Stimulation Group | 4 | |
| Overall Study | NOT COMPLETED | the Flexible GnRh Antagonist | 3 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nausea and abdominal distention | Gastrointestinal disorders | the Progestin Primed Double Stimulation Group | 5 | 41 | 15 |
| other | nausea and abdominal distention | Gastrointestinal disorders | the Flexible GnRh Antagonist | 5 | 42 | 12 |
| other | pelvic pain | Reproductive system and breast disorders | the Progestin Primed Double Stimulation Group | 3 | 41 | 10 |
| other | pelvic pain | Reproductive system and breast disorders | the Flexible GnRh Antagonist | 3 | 42 | 8 |
| other | headache | Nervous system disorders | the Progestin Primed Double Stimulation Group | 4 | 41 | 10 |
| other | headache | Nervous system disorders | the Flexible GnRh Antagonist | 2 | 42 | 5 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | the Progestin Primed Double Stimulation Group | 0 | 41 |
| Total, all-cause mortality | the Flexible GnRh Antagonist | 0 | 42 |
| Total, other adverse events | the Progestin Primed Double Stimulation Group | 12 | 41 |
| Total, other adverse events | the Flexible GnRh Antagonist | 10 | 42 |
| Total, serious adverse events | the Progestin Primed Double Stimulation Group | 0 | 41 |
| Total, serious adverse events | the Flexible GnRh Antagonist | 0 | 42 |
Source ClinicalTrials.gov
Papers15
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| the Progestin Primed Double Stimulation Group vs the Flexible GnRh Antagonist: deaths from any cause | Trial comparisons |
| the Progestin Primed Double Stimulation Group vs the Flexible GnRh Antagonist: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04537078
GET https://conductscience.org/api/trials/v1/NCT04537078/results?page=2