IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome

NCT05756023 | Recruiting DMC

• 1 other identifier: Islam Mahfouz
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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 .

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

PCOs Patients

ACTIVE COMPARATOR

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

Procedure: the pregnancy rate at IVF / ICSI cycles

Non PCOs Patients

ACTIVE COMPARATOR

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

Procedure: the pregnancy rate at IVF / ICSI cycles

Interventions

the pregnancy rate at IVF / ICSI cycles 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; PCOs Patients

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Oligo-ovulation or anovulation.
• Clinical and/or biochemical hyper androgenesim.
• Polycystic ovaries.

You may not qualify if:

• 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

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Assuit University hospitals

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Momen Kamel, Professor

  Assiut University, Faculty of medicine, Assuit.

  STUDY CHAIR

Central Study Contacts

Islam Mahfouz, MSC

CONTACT

01118434861; islam.ibrahim@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 6, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)