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AzTrials

InfertilityNCT06475690

the Psychological Interventions for Alleviating Anxiety and Depressive Emotion Among Oocyte Retrieval Patients

A study testing Psychological interventions in people with Infertility and in Vitro Fertilization, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to learn if psychological interventions alleviate the anxious emotion of women undergoing oocyte retrieval operation with general anesthesia. The main questions it aims to answer are: If psychological interventions reduced participants' anxiety scores before the oocyte retrieval… Read more about this study

Who is it for?
Ages 20 to 50 years, women only
Conditions the study is for
Infertility, in Vitro Fertilization, Mental Health
What is being tested?
Psychological interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
8 Sep 2024to 10 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • underwent oocyte retrieval operation with general anesthesia
  • able to use smartphone to complete questionnaire

Who cannot join

  • had major psychological trauma, schizophrenia
  • morbid obesity (BMI greater than 40.0 kg/m2.)
  • serious disease of cardiovascular system including uncontrolled hypertension
  • serious endocrine system disease including uncontrolled hypothyroidism
  • history of severe adverse events related to anesthesia
  • history of substance abuse or severe allergy
  • refusal to provide written consent

Trial locations and contacts

1 site in 1 country.

China1 site
  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

Other trials in China

About this study

The goal of this clinical trial is to learn if psychological interventions alleviate the anxious emotion of women undergoing oocyte retrieval operation with general anesthesia.

The main questions it aims to answer are:

If psychological interventions reduced participants' anxiety scores before the oocyte retrieval operation. Researchers will compare psychological interventions to no interventions to see if psychological interventions work to alleviate anxious emotion. Questionnaires related anxiety were completed online before surgery by participants.

Being tested
Psychological interventions
Keywords
oocyte retrieval, Anxiety symptoms, depression symptoms, psychological intervention, intravenous anesthesia
Medical subject headings
Infertility, Psychological Well-Being, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychological interventionsOther

    Psychological interventions is used for intervention group

Study groups in NCT06475690
Study groupRoleWhat they receive
AC groupExperimentalAC group (active communication group): Prior to oocyte retrieval 24h, anesthesiologist and patient sign an informed consent form for anesthesia, then anxiety and depressive symptoms are assessed by scales including APAIS, GAD-7, PHQ-9 and HAD. This is the first score for all questionnaire. Subsequently, active communication will be performed, including addressing surgical procedures, anesthesia processes, and potential complications. No matter whether the patient asks the anesthesiologist about surgery and anesthesia or not, the active communication will be provided. One hour before surgery, patients' anxiety will be reassessed using APAIS. This is the second score for APAIS. Anxiety and depressive symptoms will be evaluated by GAD-7, PHQ-9 and HAD between 24 to 48 hours after oocyte retrieval operation. This is the second score for GAD-7, PHQ-9 and HAD.
Receives: Other: Psychological interventions
CON groupNo interventionCON group (control group): Prior to oocyte retrieval 24h, anesthesiologist and patient sign an informed consent form for anesthesia, then anxiety and depressive symptoms are assessed by scales including APAIS, GAD-7, PHQ-9 and HAD. This is the first score for all questionnaire. If a patient doesn't ask any question about surgery or anesthesia, no interpretation will be provided. That is to say, the anesthesiologist will not actively communicate with the patient about surgical and anesthesia issues. One hour before surgery, patients' anxiety will be reassessed using APAIS. This is the second score for APAIS. Anxiety and depressive symptoms will be evaluated by GAD-7, PHQ-9 and HAD between 24 to 48 hours after oocyte retrieval operation. This is the second score for GAD-7, PHQ-9 and HAD.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The difference in incidence of anxiety 1 hour before operation between the two groups

    The degree of anxiety was measured by the Amsterdam Preoperative Anxiety and Information Scale and it is abbreviated as APAIS in the Primary Outcome. This is a six-item questionnaire. Every item is graded on a five-point scale from 1(meaning not at all) to 5 (meaning extremely). The scoring range of this scale is from 6 to 30 points, with a cutoff point of 11. Specifically, a score of ≤10 indicates no anxiety, while a score of ≥11 indicates anxiety. Each patient received two APAIS assessments, 24 hours before and 1 hour before surgery respectively. After the second assessment, the number of anxious patients in each group was calculated based on the APAIS scores. Then, the number of anxious patients divided by the total number of patients in the group is the incidence of anxiety. Finally, a statistical comparison was made to determine if there is a significant difference in incidence of anxiety between the two groups of patients.

    Measured: Each patient is assessed by APAIS for two times. The first time is 24 hours before surgery, and the second time is 1 hour before surgery.

Secondary outcomes (6)
  1. the comparison of APAIS score in two group 1h before operation

    The degree of anxiety is measured by the Amsterdam Preoperative Anxiety and Information Scale and it is abbreviated as APAIS in the outcome. This is a six-item questionnaire. Every item is graded on a five-point scale from 1( not at all) to 5 (extremely). The score range of this scale is from 6 to 30 points, with a cutoff point of 11. Specifically, a score of ≤10 indicates no anxiety, while a score of ≥11 indicates anxiety. Each patient received two APAIS assessments, 24 hours before and 1 hour before surgery respectively. After the second evaluation about APAIS, the comparison of APAIS scores is fulfilled to determine if there is a significant difference among the two groups.

    Measured: Each patient is assessed by APAIS for two times. The first time is 24 hours before surgery, and the second time is 1 hour before surgery.

  2. the comparison of incidence of postoperative anxiety between two groups

    The anxiety is measured by the Generalized anxiety disorder 7- item scale, a seven-item questionnaire, which is abbreviated as GAD-7. Every item is graded on a 4-point scale from 0 to 3. 0,1,2 and 3 stand for not at all, several days, more than half the days and nearly every day respectively. The total score ranges from 0 to 21 and 0-4, 5-9, 10-14, and 15-21 represent minimal, mild, moderate, and severe levels of anxiety respectively. A score of ≤4 represents no anxiety, while a score of ≥5 indicates the presence of anxiety. Each patient is assessed by GAD-7 twice, 24 hours before and 24~48 hours after surgery respectively. After the second GAD-7 rating, the number of anxious people and incidence of postoperative anxiety are calculated in each group and according to the GAD-7 score. Finally, a statistical comparison is made to determine whether there is a significant difference in incidence of postoperative anxiety between the two groups of patients.

    Measured: Each patient is assessed by GAD-7 twice.The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.

  3. the comparison of postoperative GAD-7 scores between two groups

    The degree of anxiety was measured by the Generalized anxiety disorder 7- item scale and it is abbreviated as GAD-7 in this outcome. This is a seven-item questionnaire. Every item is graded on a 4-point scale from 0 to 3. 0,1,2 and 3 stand for not at all, several days, more than half the days and nearly every day respectively. The total score of this scale ranges from 0 to 21, where 0-4, 5-9, 10-14, and 15-21 represent minimal, mild, moderate, and severe levels of anxiety respectively. That means a score of ≤4 represents no anxiety, while a score of ≥5 indicates the presence of mild anxiety or higher-level anxiety. After the second GAD-7 rating, GAD-7 scores between the two groups of patients are compared to determine whether there is a statistical difference.

    Measured: Each patient is assessed by GAD-7 twice. The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.

  4. the comparison of incidence of postoperative depression in two groups

    The depression is measured by the Patient Health Questionnaire 9-item scale, a nine-item questionnaire, which is abbreviated as PHQ-9. Every item is graded on a 4-point scale from 0 to 3. 0,1,2 and 3 stand for not at all, several days, more than half the days and nearly every day respectively. The total score of this scale ranges from 0 to 27, where 0-4, 5-9, 10-14, 15-20 and 21-27 represent minimal, mild, moderate, moderately severe and severe levels of depression respectively. That means a score of ≤4 represents no depression, and a score of ≥5 indicates the presence of depression. Each patient is assessed by PHQ-9 twice, 24 hours before and 24~48 hours after surgery respectively. After the second PHQ-9 rating, the incidence of depression is calculated in each group according to the PHQ-9 score. Finally, a statistical comparison is made to determine whether there is a significant difference in the incidence of postoperative depression between the two groups of patients.

    Measured: Each patient is assessed by PHQ-9 twice. The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.

  5. the comparison of postoperative PHQ-9 scores between two groups

    The degree of depression is measured by the Patient Health Questionnaire 9-item scale and it is abbreviated as PHQ-9 in this outcome. This is a nine-item questionnaire. Every item is graded on a 4-point scale from 0 to 3. 0,1,2 and 3 stand for not at all, several days, more than half the days and nearly every day respectively. The total score of this scale ranges from 0 to 27, where 0-4, 5-9, 10-14, 15-20 and 21-27 represent minimal, mild, moderate, moderately severe and severe levels of depression respectively. That means a score of ≤4 represents no anxiety, while a score of ≥5 indicates the presence of mild depression or higher-level depression. Each patient is assessed by PHQ-9 two times, 24 hours before surgery and 24~48 hours after surgery respectively. After the second PHQ-9 rating, PHQ-9 scores between the two groups of patients are compared to determine whether there was a statistical difference.

    Measured: Each patient is assessed by PHQ-9 twice. The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.

  6. the comparison of postoperative HADS scores between two groups

    The Hospital Anxiety and Depression Scale can be used to measure anxiety and depression and it is abbreviated as HADS in this outcome. This is a 14-item questionnaire. Assessment of the overall severity of anxiety and depression are both rated on four-point (0-3) scales by the researchers. HADS includes two subscales the depression subscale and the anxiety subscale. The total score of this scale ranges from 0 to 21 for each subscale. For the depression subscale it is found that a score of 7 or less for no depressive cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases combined with depression. The scoring range of anxiety subscale is the same as that of depression subscale. Each patient is assessed by HADS two times, 24 hours before surgery and 24~48 hours after surgery respectively. After the second HADS rating, HADS scores between the two groups of patients are compared to determine whether there was a statistical difference.

    Measured: Each patient is assessed by HADS twice. The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start8 Sep 2024
  3. Primary completion24 Jun 2025
  4. Study completion10 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06475690
Sponsor's protocol ID
CQB2
Status last verified
Mar 2026
First submitted
1 Jun 2024
Last updated
25 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu YF, Fu Z, Chen SW, He XP, Fan LY. The Analysis of Anxiety and Depression in Different Stages of in vitro Fertilization-Embryo Transfer in Couples in China. Neuropsychiatr Dis Treat. 2021 Feb 25;17:649-657. doi: 10.2147/NDT.S287198. eCollection 2021.

    PubMed 33658786
  • Li G, Jiang Z, Kang X, Ma L, Han X, Fang M. Trajectories and predictors of anxiety and depression amongst infertile women during their first IVF/ICSI treatment cycle. J Psychosom Res. 2021 Mar;142:110357. doi: 10.1016/j.jpsychores.2021.110357. Epub 2021 Jan 16.

    PubMed 33508704
  • Braverman AM, Davoudian T, Levin IK, Bocage A, Wodoslawsky S. Depression, anxiety, quality of life, and infertility: a global lens on the last decade of research. Fertil Steril. 2024 Mar;121(3):379-383. doi: 10.1016/j.fertnstert.2024.01.013. Epub 2024 Jan 13.

    PubMed 38224730
  • Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.

    PubMed 8623940
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171
  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941
  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

Questions about this trial

What is this clinical trial studying?

A study testing Psychological interventions in people with Infertility and in Vitro Fertilization, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference in incidence of anxiety 1 hour before operation between the two groups (time frame: Each patient is assessed by APAIS for two times. The first time is 24 hours before surgery, and the second time is 1 hour before surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06475690, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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