Infertility, IVF, Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic ovary disease, ICSI, progesterone, antagonist protocol
Brief 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.
Detailed description
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
DRUGProgesterone antagonist
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.
DRUGconventional antagonist protocol
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.
Sponsors
Fayoum University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
this is a randomized controlled non-blinded study. it will include 210 pt all of them PCO pt with infertility
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of oocytes retrieved per patient | 12 months | The number of oocyte retieved by ovum pick up after controlled ovarien stimulation |
| The number of MII oocytes/per patient | 12 months | the grade of maturity of oocyte under microscope |
| The fertilization rate/per patient. | 12 months | The number of fertilized oocyte by sperm |
| Number of frozen embryos/per patient | 12 month | the number of embryo frozen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of early OHSS yes /no | 12 months | size of th overies , presence of ascitis , pain and |
| Pregnancy outcomes | 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. |
Contacts
Primary Contactrehab A aboshama, Ass Professor
Outcome results
None listed