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NCT Number: NCT05756023

IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome

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 .

Recruiting

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. pregnancy rate

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Islam Mahfouz, MSC

CONTACT

[email protected]

01118434861

Sponsors and collaborators

Lead sponsor

Egymedicalpedia

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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