DRUG
Dydrogesterone Oral Tablet
Dydrogesterone 20mg tablets daily in PPOS protocol in ovarian stimulation starting from day 2 or 3 of the menstrual cycle until the triggering day
PPOS Protocol Versus GnRH Anatagonist for Expected Normal Responder Patients Undergoing ART : a Randomized Clinical Trial
Status
Completed
Phase
Phase 3
Enrollment
328
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full detailed description
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.
Interventions
Treatment arms and agents.
DRUG
Cetrorelix (Cetrotide)
This will be the conventional antagonist in ovarian stimulation given from day 6 of the menstrual cycle until the triggering day
Timeline
From registration to results.
First posted
Mar 11, 2025
Study start
Jan 3, 2023
Primary completion
Oct 31, 2024
Study completion
Feb 28, 2025
Results posted
Not reported
Registry updated
Mar 11, 2025
Outcomes
What the study measures.
Primary outcomes
clinical pregnancy
Time frame · 7 weeks of gestational age
The presence of fetal pulsations by ultrasound at 7 weeks of gestational age
Secondary outcomes
Incidence of moderate/severe OHSS
Time frame · before triggering injection and within 9 days after triggering injection
Number of metaphase 2 oocytes
Time frame · within 1 day of ovum pick up
number of 2 PN embryos
Time frame · within 1 day of ovum pick up
Biochemical pregnancy
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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 39 Years
- Sex
- FEMALE
- Healthy volunteers
- No
Inclusion Criteria: * • Women who had history of infertility for ≥1 year. * Women whose age \<40 years old by the end of the study. * Anti-Mullerian hormone \> 1.2 ng/ml. * Antral follicle count ≥ 5. Exclusion Criteria: * • Age ≥ 40 years old. * Women who are diagnosed as polycystic ovarian syndrome. * Women with endometriosis stage 3 or 4. * Documented previous IVF/ICSI cycles with no oocytes retrieved. * Women with contraindications to controlled ovarian stimulation. * Patients who refuse to share in the study.
Study locations
1 registered sites.
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Ciro University Kasr Alainy OBGYN Hospital
Cairo, Alquahira, Egypt
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Cetrorelix.
NCT IDStudyPhase / statusEnrollmentUpdated
Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI
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Not yet recruiting
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2026-07
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist for Ovarian Stimulation in IVF/ICSI
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Not yet recruiting
189
2026-07
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
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Phase 3
Recruiting
266
2026-07
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Not applicable
Recruiting
150
2026-06
Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation
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Phase 2
Recruiting
120
2026-05
Progesterone Primed Protocol Versus GnRH Antagonist in With PCO Undergoing ICSI
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Phase 2 / Phase 3
Completed
200
2026-04
NATural Ovarian Stimulation
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Phase 4
Completed
129
2026-04
Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, Prior Chemotherapy for Breast Cancer
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Phase 2
Active, not recruiting
102
2026-03
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