ISRCTN ISRCTN84083580
DOI https://doi.org/10.1186/ISRCTN84083580
Submission date
12/04/2024
Registration date
17/04/2024
Last edited
24/03/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
The number of women who desire fertility at an advanced age is increasing; however, the fertility rate among women has declined over the last two decades. Various assisted reproductive technologies have emerged globally in medical care to assist women of advanced maternal age seeking pregnancy. Oocyte cryopreservation enables women to freeze their eggs at an earlier age for potential future use. This study aims to collect the perspectives of women living in Riyadh, Saudi Arabia regarding egg freezing.

Who can participate?
Women aged 18–47 years who had their eggs frozen at the center between 01/01/2019 and 01/08/2022 for social and medical reasons

What does the study involve?
A self-administered questionnaire was distributed to 100 women attending a private clinic at the Thuriah Medical Centre in Riyadh, Saudi Arabia, who underwent oocyte cryopreservation for various reasons. Semi-structured interviews were conducted face-to-face or via teleconference among 15 women who expressed interest in participating in the recorded interviews, which lasted between 11 and 25 minutes.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Thuraih (Saudi Arabia)

When is the study starting and how long is it expected to run for?
January 2019 to June 2023

Who is funding the study?
King Fahad Medical City (Saudi Arabia)

Who is the main contact?
Dr Fatimah Alzahrani, Dr.fatimah2013@gmail.com

Contact information

Dr Fatimah Alzahrani
Principal Investigator

Riyadh, KSA
Riyadh
-
Saudi Arabia

ORCiD logoORCID ID 0009-0009-4107-9927
Phone +966 (0)531263571
Email dr.fatimah2013@gmail.com
Dr Dania Aljaroudi
Public, Scientific, Principal Investigator

Riyadh, KSA
Riyadh
-
Saudi Arabia

Phone +966 (0)504435931
Email daljaroudi@kfmc.med.sa

Study information

Study designMixed-methods study
Primary study designObservational
Secondary study designMixed methods study
Study setting(s)Community, Hospital, Internet/virtual
Study typeOther, Quality of life
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleKnowledge and attitudes of women toward oocyte freezing at a private medical center in Saudi Arabia: a mixed-methods study
Study objectivesWhat are the perspectives of women living in Riyadh, Saudi Arabia regarding egg freezing?
Ethics approval(s)

Approved 02/11/2022, King Fahad Medical City (Riyadh, SA, Riyadh, 11525, Saudi Arabia; +966 (0)112889999; hsakkijha@kfmc.med.sa), ref: FWA00018774

Health condition(s) or problem(s) studiedOocyte freezing
InterventionThis sequentially designed mixed-methods study was conducted at the Al Thuriah Medical Center in Riyadh, Saudi Arabia. The women included in this study were aged 18–47 years and had their oocytes frozen at the center between 01/01/2019 and 01/08/2022 for social and medical reasons. The participants were recruited from 01/12/2022 to 29/06/2023. Patients were contacted using their phone numbers from documents and records to obtain their permission to participate in the study. To acquire insight into the various viewpoints, deliberate sampling was performed to include participants with the greatest variance in age, location, social position, and number of cryopreserved oocytes. The primary researcher contacted the women in person, by phone, or using WhatsApp to determine their interest in the study. Women who refused to participate in the study due to time constraints, emotional issues, religious beliefs, or lack of interest or response, were excluded. Of the 15 women who participated, 10 were approached face-to-face in various locations, four were interviewed in the hospital, and one was interviewed at a coffee shop. Ethical approval for this study was obtained from the Thuriah Institutional Review Board and King Fahad Medical City before the commencement of the study (Protocol No. 22-256E). Each participant was provided information regarding the study, and informed written consent was obtained from all participants. Confidentiality of patient information was maintained.

Quantitative data processing:
The Freezing Oocyte Questionnaire was initially developed in English and later translated into Arabic. The questionnaire, comprising six questions, was constructed based on previously published research and was translated into Arabic before distribution (Lallemant et al., 2016). The first part recorded the demographic information of the participants, such as age, nationality, area of residence, occupation, and social status. The second part included six multiple-choice questions to assess their knowledge about freezing oocytes, such as indications for egg freezing, techniques used, and potential complications. Parts three, four, and five recorded the medical, social, and ethical reasons associated with egg freezing, respectively. The final section included direct questions about oocyte freezing and its future applications. A univariate analysis was performed to provide an overview of the findings. Data were analyzed using the Statistical Package for Social Sciences (SPSS) software version 21 for Windows (IBM Corp., Armonk, NY, USA).

Qualitative data processing:
Semi-structured interviews were conducted face-to-face or via teleconferencing. The interviews lasted between 11 and 25 min each. The data obtained were analyzed using thematic analysis, which was performed in phases. The first stage of data familiarization involved the transcription of data and the writing of notes on early concepts. In the second stage, the initial codes were produced by employing open codes for important traits across the dataset. The third stage involved creating themes by categorizing the codes into groups based on similarities in meaning. Overarching patterns were also observed. The co-investigators evaluated, reviewed, and refined the themes during the fourth phase.
Intervention typeOther
Primary outcome measure1. Patient satisfaction with oocyte freezing measured using the Freezing Oocyte Questionnaire at a single timepoint
2. Patient satisfaction with oocyte freezing measured using patient interviews at a single timepoint
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/01/2019
Completion date29/06/2023

Eligibility

Participant type(s)Patient
Age groupMixed
Lower age limit18 Years
Upper age limit47 Years
SexFemale
Target number of participants100
Total final enrolment100
Key inclusion criteria1. Women aged 18–47 years
2. Had their oocytes frozen at the center between 01/01/2019 and 01/08/2022 for social and medical reasons
Key exclusion criteriaWomen who refused to participate in the study due to time constraints, emotional issues, religious beliefs, or lack of interest or response
Date of first enrolment01/12/2022
Date of final enrolment29/06/2023

Locations

Countries of recruitment

  • Saudi Arabia

Study participating centre

Thuriah
Mecca Road
Riyadh
-
Saudi Arabia

Sponsor information

Thuraih
Hospital/treatment centre

Mecca Road
Riyadh
-
Saudi Arabia

Phone +966 (0)11 407 9999
Email salshehri@thuriah.com.sa
Website http://thuriah.com/

Funders

Funder type

Government

King Fahad Medical City
Government organisation / National government
Alternative name(s)
King Fahad Medical City Research Center, KFMC
Location
Saudi Arabia

Results and Publications

Intention to publish date29/06/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from Dr Fatimah Alzahrani (Dr.fatimah2013@gmail.com)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 22/03/2025 24/03/2025 Yes No

Editorial Notes

24/03/2025: Publication reference added.
17/04/2024: Study's existence confirmed by King Fahad Medical City.