IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome

Not Applicable

Recruiting

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

• Registration Number: NCT05756023
• Lead Sponsor: Egymedicalpedia

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

Study Timeline

• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-03-06
• Study Start: 2023-06-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCOs Patients	the pregnancy rate at IVF / ICSI cycles	To compare the pregnancy rate at IVF / ICSI cycles in patients with PCOs
Non PCOs Patients	the pregnancy rate at IVF / ICSI cycles	To compare the pregnancy rate at IVF / ICSI cycles in patients with without PCOs

Primary Outcome Measures

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

Trial Locations

Locations (1)

Assuit University hospitals; 🇪🇬 Assiut, Egypt