Status
Unknown
Phase
Not applicable
Enrollment
210
Locations
0
Results
Not posted
Publications
0
Study summary
this study is designed to compare the Progesterone primed ovarian stimulation protocol versus the antagonist protocol as a method to stimulate PCO patients in ICSI cycles to decrease cost and decrease OHSS.
A Randomized controlled, non-blinded study (parallel-group study with 1:1 randomization) will be conducted at a Specialized Authorized IVF unit starting from January 2023 till completing the sample size. Randomization will be generated by a computer and held with one of the experimenters, and (n) of the black and red cards will be used for allocation concealment. Participants: All PCO patients will be given informed consent about the study aims and written consent will be taken at the first visit to the infertility clinic of the Specialized Authorized IVF unit. Patients will be categorized as (Group A) Progesterone primed ovarian stimulation protocol. (Group B) conventional antagonist protocol.
Interventions
DRUG
Group (A): Women in progesterone primed (PPOS) will prescribed 30 mg oral dose of dydrogesterone (duphaston, Abbott, Egypt) from the 2nd day of the cycle and continued until triggering day. Vaginal sonography will be done for all patients since the 6th day of the cycle.
DRUG
Group (B): Women in the antagonist group will be monitored by transvaginal ultrasonography till the size of dominant follicles reached to 12-13 mm, 0.25 mg of cetrotide (Merck-Serono ,Germany) will be injected subcutaneously daily and continued until triggering day, follow up for all patients in both groups by transvaginal ultrasound every other day.
Timeline
First posted
May 6, 2023
Study start
Jun 1, 2023
Primary completion
Jun 1, 2024
Study completion
Jul 1, 2024
Results posted
Not reported
Registry updated
May 6, 2023
Outcomes
The number of oocytes retrieved per patient
Time frame · 12 months
The number of oocyte retieved by ovum pick up after controlled ovarien stimulation
The number of MII oocytes/per patient
Time frame · 12 months
the grade of maturity of oocyte under microscope
The fertilization rate/per patient.
Time frame · 12 months
The number of fertilized oocyte by sperm
Number of frozen embryos/per patient
Time frame · 12 month
the number of embryo frozen
Incidence of early OHSS yes /no
Time frame · 12 months
size of th overies , presence of ascitis , pain and
Pregnancy outcomes
Time frame · 12 months
1. Chemical pregnancy will be determined by serum β hCG \> 50 IU/L two weeks after ET. 2. In addition, clinical pregnancy will be confirmed by detecting fetal heartbeats 2 weeks following the positive β hCG.
Eligibility
Inclusion Criteria: \- 1. PCO patients based on Rotterdam criteria (2003), including polycystic ovaries, oligo-anovulation, as well as the biochemical or clinical signs of hyperandrogenism (Rotterdam et al, 2003). 2\. Age less than 40 years old. 3. Primary infertility for 2 years and secondary infertility for 1 year. Exclusion Criteria: \- Non-PCO patients as: * Congenital adrenal hyperplasia * Hyperprolactinemia. * Recurrent implantation failure. * Hydrosalpinx. * Uterine pathology. * Uncontrolled medical disorder eg DM, HTN * Male factor infertility.
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
No PMID-linked publications were present in this registry snapshot.
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