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Trial Title:
IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome
NCT ID:
NCT05756023
Condition:
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
the pregnancy rate at IVF / ICSI cycles
Description:
To study and compare other parameters between the PCOS and non PCOS group, and inside the
PCOS group itself eg ; patients with PCOS who have ovarian drilling and non drilling PCOS
Arm group label:
Non PCOs Patients
Arm group label:
PCOs Patients
Summary:
Polycystic ovarian syndrome (PCOS) occurs in 5% to 10% of all women of reproductive age
and 50% of women who present with sub-fertility due to anovulatory infertility . Clear
diagnostic criteria for this condition were identified at the consensus meeting of the
European Society of Human Reproduction and Embryology and the American Society for
Reproductive Medicine .
Detailed description:
Sub-fertile women with PCOS will usually benefit from conventional treatments, such as
lifestyle changes, ovulation induction, or laparoscopic ovarian drilling, but some will
ultimately need assisted reproductive techniques, either if they will need or if they
wish, such as controlled ovarian hyperstimulation and IVF.
In these cases, controlled ovarian hyperstimulation is closely related to high drug
costs, need for daily injections and frequent monitoring, whereas it sometimes results in
an increased rate of cycle cancellations and potential life threatening complications due
to ovarian hyperstimulation syndrome and in the retrieval of immature oocytes, leading to
poor fertilization and lower cleavage, pregnancy, and live birth rates compared to the
conventional IVF cycles ,although this has not been confirmed by other studies .
In addition, ovulation induction is associated with a high risk of multiple pregnancies
due to multiple follicular development, so that it has to be individualized and closely
monitored.
In-vitro fertilization (IVF) is a common therapeutic modality used in infertile women.
IVF has different success rates in different subgroups of patients.
It is necessary to alter the common standard protocols to overcome the potential
obstacles in some populations of patients and achieve the best results . Obesity with
PCOS status of patient may decrease the fertilization rate and clinical pregnancy chance
after IVF (probably by decreasing the oocyte count and increasing the gonadotropin
resistance); however, the results of different studies are conflicting
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Oligo-ovulation or anovulation.
- Clinical and/or biochemical hyper androgenesim.
- Polycystic ovaries.
Exclusion Criteria:
1. Androgen-secreting tumors (ovarian or adrenal).
2. Adult-onset congenital adrenal hyperplasia.
3. Thyroid diseases.
4. Cushing's syndrome.
5. Diabetes Mellitus.
6. recurrent ICSI failure
7. endocrine, hematologic and autoimmune disorders
8. Non chromosomal and genetic abnormalities
9. Major uterine anomalies, bad surgical history, sever endometriosis, , hydrosalpinx,
uterine fibroids
10. Azospermia
Gender:
Female
Minimum age:
20 Years
Maximum age:
35 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Assuit University hospitals
Address:
City:
Assiut
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Ahmed Alaa-Eldien, Professor
Phone:
01006184921
Email:
ahmedalaa11282@aun.edu.eg
Contact backup:
Last name:
Reda Salah, M.D
Phone:
01094877320
Email:
rsalah313@aun.edu.eg
Investigator:
Last name:
Momen Kamel, Professor
Email:
Principal Investigator
Start date:
June 1, 2023
Completion date:
December 15, 2026
Lead sponsor:
Agency:
Egymedicalpedia
Agency class:
Industry
Source:
Egymedicalpedia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05756023
