IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome

IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome Compared With Non Polycystic Ovary Syndrome Women

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 .

Study Overview

• Status: Recruiting
• Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• Intervention / Treatment: Procedure: the pregnancy rate at IVF / ICSI cycles

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

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Islam Mahfouz, MSC; Phone Number: 01118434861; Email: islam.ibrahim@med.aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assuit University hospitals
    • Contact: Ahmed Alaa-Eldien, Professor; Phone Number: 01006184921; Email: ahmedalaa11282@aun.edu.eg
    • Contact: Reda Salah, M.D; Phone Number: 01094877320; Email: rsalah313@aun.edu.eg
    • Principal Investigator: Momen Kamel, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PCOs Patients; To compare the pregnancy rate at IVF / ICSI cycles in patients with PCOs	Procedure: 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
Active Comparator: Non PCOs Patients; To compare the pregnancy rate at IVF / ICSI cycles in patients with without PCOs	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy rate	To compare the pregnancy rate at IVF / ICSI cycles between women with PCOS and non PCOS women	From baseline to 15 days after the embryo transfere day.

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Investigators: Study Chair: Momen Kamel, Professor, Assiut University, Faculty of medicine, Assuit.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: Islam Mahfouz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No