Sleep Length and Euploid Embryo Transfer Prospective Study

NCT06139757 | Recruiting

• 1 other identifier: STU00219133
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep is a critical component of daily life that significantly influences health and well-being. Despite the integral role sleep plays in life, its effect on women's reproductive health, and its subsequent impact on fertility, is largely understudied. The purpose of the SLEEP Study is to investigate the link between sleep and fertility. Participants will use a wireless wearable device mounted on the finger to measure sleep in the weeks preceding and following an embryo transfer during treatment with in vitro fertilization. The investigators hope that these findings will inform future therapies that improve sleep and fertility outcomes.

Conditions

Infertility, Female

Keywords

wearable; sleep

Outcome Measures

Primary Outcomes (1)

• Effect of sleep on IVF outcomes

  To elucidate a potential correlation between average total sleep time and other sleep parameters (sleep efficiency, wake after sleep onset, and sleep stages) during the pre- and post-embryo transfer windows on rates of implantation, clinical pregnancy, ongoing pregnancy, and miscarriage.

  Sleep parameters will be measured on a daily basis

Secondary Outcomes (3)

• Effect of anxiety on sleep parameters

  Anxiety will be assessed at baseline with GAD-7

• Effect of depression on sleep parameters

  Depressive symptoms will be assessed at baseline with PHQ-9

• Effect of frozen embryo transfer protocol type on sleep parameters and pregnancy outcomes

  Sleep parameters will be measured on a daily basis. Pregnancy outcomes will be measured at time of pregnancy testing, and if positive up to 8-10 weeks of gestation

Study Arms (1)

Euploid embryo transfer group

Participants will wear the Oura Ring continuously for data collection starting in the month prior to their embryo transfer date. They will wear the Oura Ring throughout the preparation, embryo transfer, and post-transfer until either a negative pregnancy test or, if positive, until 8 weeks gestation. The study time for each participant will thus extend from either 5 weeks for negative pregnancy tests, to 10 weeks for normally continuing pregnancies.

Device: Oura ring

Interventions

Oura ring DEVICE

Patient will wear Oura ring before and after embryo transfer. They will be blinded to sleep data during this period. Thus the intervention of wearing the ring to track sleep will not affect outcomes, but rather track the outcome of sleep.

Euploid embryo transfer group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients anticipating frozen embryo transfer of a genetically tested, euploid embryo at Northwestern's Center for Fertility and Reproductive Medicine.

You may qualify if:

• Undergoing a single euploid frozen embryo transfer
• Patient's 1st, 2nd, or 3rd embryo transfer (prior fresh or frozen transfers included)

You may not qualify if:

• Primary infertility diagnosis of polycystic ovary syndrome
• BMI \> 40
• Diagnosis of primary ovarian insufficiency (FSH \> 40)
• Night work
• High risk of poor outcomes of fertility treatment \[\> 2 prior miscarriages (women with recurrent pregnancy loss), significant uterine factor infertility \[\>/= 2 myomectomies (open abdominal or laparoscopic) or any non-hystoeroscopic myomectomy entering the endometrial cavity\]
• Undergoing medical fertility preservation for a significant medical co-morbidity
• Current cancer diagnosis
• \> 3 prior failed embryo transfers in attempt for current live birth

Sponsors & Collaborators

• Northwestern University: lead
• Friends of Prentice: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (35)

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Related Links

• World Health Organization. Current Practices and Controversies in Assisted Production. Geneva, Switzerland, 2002.
• Sleep disturbances high in patients seeking fertility preservation

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Jessica Walter, MD, MSCE

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah C Cromack, MD

CONTACT

312-926-8244; sarah.capelouto@nm.org

Jessica Walter, MD

CONTACT

312-926-8244; jessica.walter@nm.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2023
• First Posted: November 18, 2023
• Study Start: January 17, 2024
• Primary Completion: January 15, 2025
• Study Completion: July 31, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)