What Amount of Stress is Enough for a Successful Conception?

NCT04160611 | Unknown Phase 3

• 1 other identifier: EP-9157/18-14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

In Vitro Fertilization; Stress; Midazolam Adverse Reaction; Stress, Emotional

Keywords

IVF; stress; midazolam; premedication

Outcome Measures

Primary Outcomes (1)

• Stress Levels in Premedicated Women

  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.

  3 hours post-surgery

Study Arms (2)

Premedication with Midazolam

EXPERIMENTAL

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

No Premedication with Midazolam

NO INTERVENTION

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.

Interventions

Midazolam 7.5mg DRUG

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

Premedication with Midazolam

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female - IVF procedure related
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead

Study Sites (1)

University Hospital Center Sestre milosrdnice

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vesna Košec, MD, PhD

  Department of Gynecology and Obstetrics, University Hospital Center Sestre milosrdnice, Zagreb, Croatia

  STUDY CHAIR

Central Study Contacts

Andro Košec, MD, PhD

CONTACT

+385989817156; andro.kosec@yahoo.com

Maja Pešić, MD

CONTACT

+385989817156; majapesic1980@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Otorhinolaryngologist and Head and Neck Surgeon

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

Study Record Dates

• First Submitted: November 9, 2019
• First Posted: November 13, 2019
• Study Start: September 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: October 1, 2020
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)