Clinical trial NCT05756023: 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
Overall status: RECRUITING
Phase: NA
Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2023-03-06
Enrollment: 156
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: pregnancy rate
timeFrame: From baseline to 15 days after the embryo transfere day.
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University hospitals
Study officials:
affiliation: Assiut University, Faculty of medicine, Assuit.
name: Momen Kamel, Professor
role: STUDY_CHAIR
References: