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Trial Title:
Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patient
NCT ID:
NCT05847660
Condition:
Polycystic Ovary Syndrome
Infertility
IVF
Conditions: Official terms:
Polycystic Ovary Syndrome
Infertility
Cetrorelix
Progesterone
Dydrogesterone
Conditions: Keywords:
Polycystic ovary disease
ICSI
progesterone
antagonist protocol
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
this is a randomized controlled non-blinded study. it will include 210 pt all of them PCO
pt with infertility
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Progesterone antagonist
Description:
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.
Arm group label:
Progesterone primed ovarian stimulation protocol.
Other name:
duphaston
Intervention type:
Drug
Intervention name:
conventional antagonist protocol
Description:
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.
Arm group label:
conventional antagonist protocol.
Other name:
0.25 mg of cetrotide
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Gender based:
Yes
Minimum age:
20 Years
Maximum age:
40 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
June 1, 2023
Completion date:
July 1, 2024
Lead sponsor:
Agency:
Fayoum University
Agency class:
Other
Source:
Fayoum University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05847660
