Mood DisordersIVFNCT01032421
Gonadal Steroid Manipulation and Personality Characteristics: Association With Mood Fluctuations and in Vitro Fertilization (IVF) Outcomes
An observational study of Mood Disorders, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The current study's primary aim is to investigate the association between neuroendocrine fluctuations and mood disorders by monitoring mood states over distinct hormonal phases during in-vitro-fertilization (IVF) treatment. Read more about this study
- Who is it for?
- Ages Up to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mood Disorders
- What is being tested?
- IVF procedure
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Dec 2007
- Phase
- Observational
- 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 Up to 42 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women admitted for their first or second IVF cycle, under the age of 42. Please see the detailed inclusion and exclusion criteria.
Who may be able to join
- Admitted for their first or second IVF cycle;
- Demonstrated sufficient communication skills and level of understanding in the Hebrew language;
- signed an informed consent;
- Were under the age of 42;
- Were not suffering from endometriosis or male factor in patients who underwent testicular sperm extraction (TESE);
- Were not under psychotherapeutic or psychopharmacological treatment. The accepted indications for the IVF included a female factor, male factor or unexplained infertility.
Who cannot join
- 1. All others.
About this study
Official title: Gonadal Steroid Manipulation and Personality Characteristics: Association With Mood Fluctuations & IVF Outcomes
The current study's primary aim is to investigate the association between neuroendocrine fluctuations and mood disorders by monitoring mood states over distinct hormonal phases during in-vitro-fertilization (IVF) treatment. The secondary goal of this study is to explore psychological profiles and coping mechanisms of women undergoing IVF, and to identify the ones that are associated with successful psychological adaptation to the process and a successful biological outcome.
- Conditions
- Mood Disorders
- Being tested
- IVF procedure
- Keywords
- women admitted to the In Vitro Fertilization unit
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVF procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| GNRH | Observational (IVF is not done as part of the study) Receives: Procedure: IVF procedure |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032421
- Sponsor's protocol ID
- 04-284
- Acronym
- IVF
- Status last verified
- Dec 2009
- First submitted
- 25 Nov 2009
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Zaig I, Azem F, Schreiber S, Amit A, Litvin YG, Bloch M. Psychological response and cortisol reactivity to in vitro fertilization treatment in women with a lifetime anxiety or unipolar mood disorder diagnosis. J Clin Psychiatry. 2013 Apr;74(4):386-92. doi: 10.4088/JCP.12m07805.
PubMed 23656846Bloch M, Azem F, Aharonov I, Ben Avi I, Yagil Y, Schreiber S, Amit A, Weizman A. GnRH-agonist induced depressive and anxiety symptoms during in vitro fertilization-embryo transfer cycles. Fertil Steril. 2011 Jan;95(1):307-9. doi: 10.1016/j.fertnstert.2010.07.1073.
PubMed 20801439
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gonadal Steroid Manipulation and Personality Characteristics: Association With Mood Fluctuations & IVF Outcomes
- ClinicalTrials.gov ID
- NCT01032421
- Acronym / sponsor ID
- IVF / 04-284
- Conditions
- Mood Disorders
- Keywords
- women admitted to the In Vitro Fertilization unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study's primary aim is to investigate the association between neuroendocrine fluctuations and mood disorders by monitoring mood states over distinct hormonal phases during in-vitro-fertilization (IVF) treatment. The secondary goal of this study is to explore psychological profiles and coping mechanisms of women undergoing IVF, and to identify the ones that are associated with successful psychological adaptation to the process and a successful biological outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GNRH | – | Procedure: IVF procedureObservational (IVF is not done as part of the study) |
Who may qualify
- Ages
- Up to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women admitted for their first or second IVF cycle, under the age of 42. Please see the detailed inclusion and exclusion criteria.
Key inclusion criteria (6 listed)
- Admitted for their first or second IVF cycle;
- Demonstrated sufficient communication skills and level of understanding in the Hebrew language;
- signed an informed consent;
- Were under the age of 42;
- Were not suffering from endometriosis or male factor in patients who underwent testicular sperm extraction (TESE);
Key exclusion criteria (1 listed)
- 1. All others.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVF procedure | Procedure or surgery | GNRH |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
- Derived from this study: PubMed 23656846Zaig I, Azem F, Schreiber S, Amit A, Litvin YG, Bloch M. Psychological response and cortisol reactivity to in vitro fertilization treatment in women with a lifetime anxiety or unipolar mood disorder diagnosis. J Clin Psychiatry. 2013 Apr;74(4):386-92. doi: 10.4088/JCP.12m07805.
- Derived from this study: PubMed 20801439Bloch M, Azem F, Aharonov I, Ben Avi I, Yagil Y, Schreiber S, Amit A, Weizman A. GnRH-agonist induced depressive and anxiety symptoms during in vitro fertilization-embryo transfer cycles. Fertil Steril. 2011 Jan;95(1):307-9. doi: 10.1016/j.fertnstert.2010.07.1073.
Related trials for Mood Disorders
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorders, run by Tel-Aviv Sourasky Medical Center.
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 6 inclusion and 1 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 15 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032421, which also lists 2 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 15 Dec 2009.