Female Pelvic Blood Flow Under Simulated Microgravity

NCT06633692 | Completed

• 1 other identifier: 2024.238.IRB1.028
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Spaceflight is characterized by unique physiological adaptations. Cardiovascular system response to the microgravity includes major changes. During spaceflight, body fluids are displaced in the cephalad direction due to changes in gravity, resulting in altered vascular dynamics and the redistribution of the blood circulation. As the investigators approach crewed Moon and Mars missions and commercial spaceflights become more frequent, understanding the impact of space travel on women's health is crucial. Despite the known importance of these vascular dynamics in both clinical and research settings, there is limited information on the pelvic blood flow under microgravity. The aim of this project is to fill this gap by analyzing the impact of simulated microgravity on the perfusion of female reproductive organs using Doppler velocimetry. Head-down tilt (HDT) position is an established model in literature for simulated microgravity on Earth. This prospective study will assess pelvic organ blood flow in the supine position after a period of acclimation as a control. After completing Doppler measurements in the supine position, the participant will be placed in the HDT position. Following a period of acclimation, Doppler measurements will be repeated on the same vessels.During both supine and simulated microgravity conditions, vital signs (i.e., blood pressure, heart rate, oxygen saturation) will be collected.

Conditions

Uterine; Ovary; Microgravity; Blood Flow

Keywords

microgravity; female pelvic blood flow; doppler ultrasound

Outcome Measures

Primary Outcomes (1)

• Internal iliac artery Doppler indices before and after HDT

  Internal iliac artery Doppler flow indices will be obtained in supine and HDT positions after acclimation periods

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Ovarian artery Doppler indices before and after HDT

  through study completion, an average of 1 year

Study Arms (1)

Simulated microgravity

EXPERIMENTAL

Pre- and post-assessment of pelvic blood flow in response to simulated microgravity will be performed in the same participant.

Other: Head down tilt (HDT)

Interventions

Head down tilt (HDT) OTHER

In the head-down tilt intervention, a participant is positioned on a tilt table, initially in supine position and afterwards with their head inclined downward at a specific angle. This position causes a shift of body fluids towards the head, mimicking the fluid redistribution observed in microgravity conditions in space.

Simulated microgravity

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old healthy female individuals

You may not qualify if:

• History of hysterectomy and/or oophorectomy
• Pregnancy
• Premature ovarian insufficiency
• Women with reproductive tract pathologies
• Cardiovascular diseases

Sponsors & Collaborators

• Ceren UNAL: lead

Study Sites (1)

Koc Universoty Hospital

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (7)

• Perhonen MA, Franco F, Lane LD, Buckey JC, Blomqvist CG, Zerwekh JE, Peshock RM, Weatherall PT, Levine BD. Cardiac atrophy after bed rest and spaceflight. J Appl Physiol (1985). 2001 Aug;91(2):645-53. doi: 10.1152/jappl.2001.91.2.645.

  PMID: 11457776 BACKGROUND

• Waters WW, Ziegler MG, Meck JV. Postspaceflight orthostatic hypotension occurs mostly in women and is predicted by low vascular resistance. J Appl Physiol (1985). 2002 Feb;92(2):586-94. doi: 10.1152/japplphysiol.00544.2001.

  PMID: 11796668 BACKGROUND

• Herault S, Fomina G, Alferova I, Kotovskaya A, Poliakov V, Arbeille P. Cardiac, arterial and venous adaptation to weightlessness during 6-month MIR spaceflights with and without thigh cuffs (bracelets). Eur J Appl Physiol. 2000 Mar;81(5):384-90. doi: 10.1007/s004210050058.

  PMID: 10751099 BACKGROUND

• Shen M, Frishman WH. Effects of Spaceflight on Cardiovascular Physiology and Health. Cardiol Rev. 2019 May/Jun;27(3):122-126. doi: 10.1097/CRD.0000000000000236.

  PMID: 30365406 BACKGROUND

• Gallo C, Ridolfi L, Scarsoglio S. Cardiovascular deconditioning during long-term spaceflight through multiscale modeling. NPJ Microgravity. 2020 Oct 1;6:27. doi: 10.1038/s41526-020-00117-5. eCollection 2020.

  PMID: 33083524 BACKGROUND

• Tuday EC, Meck JV, Nyhan D, Shoukas AA, Berkowitz DE. Microgravity-induced changes in aortic stiffness and their role in orthostatic intolerance. J Appl Physiol (1985). 2007 Mar;102(3):853-8. doi: 10.1152/japplphysiol.00950.2006. Epub 2006 Nov 2.

  PMID: 17082368 BACKGROUND

• Mathyk B, Imudia A, Quaas A, Halicigil C, Karouia F, Avci P, Nelson N, Guzeloglu-Kayisli O, Denbo M, Sanders L, Scott R, Basar M, Guevara-Cerdan A, Strug M, Monseur B, Kayisli U, Szewczyk N, Mason CE, Young SL, Tasoglu S, Costes S, Beheshti A.Understanding how space travel affects the female reproductive system to the Moon and beyond. npj Womens Health 2, 20 (2024). https://doi.org/10.1038/s44294-024-00009-z

  BACKGROUND

MeSH Terms

Interventions

Head-Down Tilt

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Afak Durur Karakaya, M.D.

  Koç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Model Details: Pre- and post-assessment of the pelvic blood flow in response to simulated microgravity

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: December 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: August 1, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

TU (1)