What Amount of Stress is Enough for a Successful Conception?

Sponsor

University Hospital "Sestre Milosrdnice" (Other)

Overall Status

Unknown status

CT.gov ID

NCT04160611

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to determine whether premedication with midazolam before oocyte aspiration in IVF procedures affects the amount of (oxidative) stress in women undergoing IVF and whether stress is also transmitted to the follicular fluid of aspirated follicles. The primary endpoint is the impact of stress during aspiration on the success of medically assisted fertilization (IVF / ICSI in the stimulated cycle).

Condition or Disease	Intervention/Treatment	Phase
In Vitro Fertilization Stress Midazolam Adverse Reaction Stress, Emotional	Drug: Midazolam 7.5mg	Phase 3

Detailed Description

The procedure of in vitro fertilisation (IVF) is used to treat the infertility problems. The procedure includes ovary aspiration, to isolate oocytes. During the aspiration the patient is sedated with short-term intravenous aesthetic. Premedication is often used in anaesthesiology, and includes drugs application 30 minutes prior to procedure to sedate and treat the anxieties of the patient. One of the most often used drugs in premedication is midazolam. As the procedure is quite stressful for the patients, our aim is to investigate the influence of midazolam premedication on the stress release during the oocyte aspiration procedure, as well as its influence on the whole IVF procedure. Therefore, patients will be divided into two groups, control and midazolam. Blood samples will be taken before and during the procedure. Stress, antioxidant parameters (with glutathione and catalase) and oxidative status will be monitored in serum and follicular fluid.

The results will be correlated with subjective stress levels in the two groups in an effort to establish ties with IVF results.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two randomized groups receiving midazolam/not receiving midazolam premedication before oocyte aspiration procedures as part of IVF proceduresTwo randomized groups receiving midazolam/not receiving midazolam premedication before oocyte aspiration procedures as part of IVF procedures

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Impact of Premedication With Midazolam in Aspiration Procedures On Stress Levels During IVF Procedures

Actual Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Premedication with Midazolam Patients will be randomly divided into two groups, control and midazolam. The midazolam group will receive midazolam premedication in such a way that 7.5mg midazolam will be taken orally 30 minutes before the aspiration procedure. Because midazolam causes sedation, the woman will be monitored by midazolam after medical premedication to avoid possible complications and will not be allowed to get out of bed on her own for 30 minutes. After 30 min, all women, both test and control group, will begin aspiration under the control of transvaginal ultrasound of one or more mature follicles (TUGOR - transvaginal ultrasound guided oocyte retrieval) under short term general anesthesia.	Drug: Midazolam 7.5mg The patient groups differ only in that respect that the intervention group will receive oral midazolam 7.5 g before oocyte aspiration.
No Intervention: No Premedication with Midazolam Women in the control group will undergo aspiration under the control of transvaginal ultrasound of one or more mature follicles (TUGOR - transvaginal ultrasound guided oocyte retrieval) under short term general anesthesia.

Arm

Intervention/Treatment

Experimental: Premedication with Midazolam

Patients will be randomly divided into two groups, control and midazolam. The midazolam group will receive midazolam premedication in such a way that 7.5mg midazolam will be taken orally 30 minutes before the aspiration procedure. Because midazolam causes sedation, the woman will be monitored by midazolam after medical premedication to avoid possible complications and will not be allowed to get out of bed on her own for 30 minutes. After 30 min, all women, both test and control group, will begin aspiration under the control of transvaginal ultrasound of one or more mature follicles (TUGOR - transvaginal ultrasound guided oocyte retrieval) under short term general anesthesia.

Drug: Midazolam 7.5mg

The patient groups differ only in that respect that the intervention group will receive oral midazolam 7.5 g before oocyte aspiration.

No Intervention: No Premedication with Midazolam

Women in the control group will undergo aspiration under the control of transvaginal ultrasound of one or more mature follicles (TUGOR - transvaginal ultrasound guided oocyte retrieval) under short term general anesthesia.

Outcome Measures

Primary Outcome Measures

Stress Levels in Premedicated Women [3 hours post-surgery]
All patients in the midazolam group will be sampled with 5 ml venepuncture prior to midazolam administration, just before the procedure, 2 hours after the procedure. A follicular fluid sample will be taken at the procedure. Samples will be stored in the freezer at -80⁰C. The total antioxidant capacity (TAC) and total oxidation capacity (TOC) of commercially available kits will be determined from plasma and follicular fluid. Whole blood will determine total glutathione and catalase activity. In addition to the total oxidation capacity, the amount of HNE-protein conjugates will be determined from the follicular fluid as an indicator of lipid peroxidation, and the Patients will be monitored after the aspiration procedure, and the success of the procedure of medically assisted fertilization, ie number of pregnancies, in the test and control group will be monitored.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Informed consent, healthy women undergoing IVF procedures for the first time

Exclusion Criteria:

Refusal to enroll, chronic endocrine and psychiatric illnesses that might affect baseline stress levels

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Center Sestre milosrdnice	Zagreb		Croatia	10000

Sponsors and Collaborators

University Hospital "Sestre Milosrdnice"

Investigators

Study Chair: Vesna Košec, MD, PhD, Department of Gynecology and Obstetrics, University Hospital Center Sestre milosrdnice, Zagreb, Croatia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andro Košec, MD, PhD, Consultant Otorhinolaryngologist and Head and Neck Surgeon, University Hospital

ClinicalTrials.gov Identifier:

NCT04160611

Other Study ID Numbers:

EP-9157/18-14

First Posted:

Nov 13, 2019

Last Update Posted:

Nov 13, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Andro Košec, MD, PhD, Consultant Otorhinolaryngologist and Head and Neck Surgeon, University Hospital

Additional relevant MeSH terms:

Midazolam

Study Results

No Results Posted as of Nov 13, 2019