IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome

NCT ID: NCT05756023

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-12-15

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

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

PCOs Patients

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

Group Type: ACTIVE_COMPARATOR

the pregnancy rate at IVF / ICSI cycles

Intervention Type: PROCEDURE

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

Non PCOs Patients

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

Group Type: ACTIVE_COMPARATOR

the pregnancy rate at IVF / ICSI cycles

Intervention Type: PROCEDURE

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

Interventions

the pregnancy rate at IVF / ICSI cycles

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Momen Kamel, Professor

Role: STUDY_CHAIR

Assiut University, Faculty of medicine, Assuit.

Locations

Assuit University hospitals

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Islam Mahfouz, MSC

Role: CONTACT

islam.ibrahim@med.aun.edu.eg

01118434861

Facility Contacts

Ahmed Alaa-Eldien, Professor

Role: primary

ahmedalaa11282@aun.edu.eg

01006184921

Reda Salah, M.D

Role: backup

rsalah313@aun.edu.eg

01094877320

Other Identifiers

Islam Mahfouz

Identifier Type: -

Identifier Source: org_study_id