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IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome

Primary Purpose

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
the pregnancy rate at IVF / ICSI cycles
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Oligo-ovulation or anovulation. Clinical and/or biochemical hyper androgenesim. Polycystic ovaries. Exclusion Criteria: Androgen-secreting tumors (ovarian or adrenal). Adult-onset congenital adrenal hyperplasia. Thyroid diseases. Cushing's syndrome. Diabetes Mellitus. recurrent ICSI failure endocrine, hematologic and autoimmune disorders Non chromosomal and genetic abnormalities Major uterine anomalies, bad surgical history, sever endometriosis, , hydrosalpinx, uterine fibroids Azospermia

Sites / Locations

  • Assuit University hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PCOs Patients

Non PCOs Patients

Arm Description

To compare the pregnancy rate at IVF / ICSI cycles in patients with PCOs

To compare the pregnancy rate at IVF / ICSI cycles in patients with without PCOs

Outcomes

Primary Outcome Measures

pregnancy rate
To compare the pregnancy rate at IVF / ICSI cycles between women with PCOS and non PCOS women

Secondary Outcome Measures

Full Information

First Posted
February 23, 2023
Last Updated
October 17, 2023
Sponsor
Egymedicalpedia
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1. Study Identification

Unique Protocol Identification Number
NCT05756023
Brief Title
IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome
Official Title
IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome Compared With Non Polycystic Ovary Syndrome Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 1, 2026 (Anticipated)
Study Completion Date
December 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCOs Patients
Arm Type
Active Comparator
Arm Description
To compare the pregnancy rate at IVF / ICSI cycles in patients with PCOs
Arm Title
Non PCOs Patients
Arm Type
Active Comparator
Arm Description
To compare the pregnancy rate at IVF / ICSI cycles in patients with without PCOs
Intervention Type
Procedure
Intervention Name(s)
the pregnancy rate at IVF / ICSI cycles
Intervention 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
Primary Outcome Measure Information:
Title
pregnancy rate
Description
To compare the pregnancy rate at IVF / ICSI cycles between women with PCOS and non PCOS women
Time Frame
From baseline to 15 days after the embryo transfere day.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Oligo-ovulation or anovulation. Clinical and/or biochemical hyper androgenesim. Polycystic ovaries. Exclusion Criteria: Androgen-secreting tumors (ovarian or adrenal). Adult-onset congenital adrenal hyperplasia. Thyroid diseases. Cushing's syndrome. Diabetes Mellitus. recurrent ICSI failure endocrine, hematologic and autoimmune disorders Non chromosomal and genetic abnormalities Major uterine anomalies, bad surgical history, sever endometriosis, , hydrosalpinx, uterine fibroids Azospermia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Islam Mahfouz, MSC
Phone
01118434861
Email
islam.ibrahim@med.aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momen Kamel, Professor
Organizational Affiliation
Assiut University, Faculty of medicine, Assuit.
Official's Role
Study Chair
Facility Information:
Facility Name
Assuit University hospitals
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Alaa-Eldien, Professor
Phone
01006184921
Email
ahmedalaa11282@aun.edu.eg
First Name & Middle Initial & Last Name & Degree
Reda Salah, M.D
Phone
01094877320
Email
rsalah313@aun.edu.eg
First Name & Middle Initial & Last Name & Degree
Momen Kamel, Professor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome

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