PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health

Infertility, Female Clinical Trial

— PROMISE  

Official title:

The PROMISE Study: PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358483
• Other study ID #: STU00215252
• Status: Recruiting
• Start date: September 7, 2021
• Est. completion date: December 2046

Study information

• Verified date: April 2022
• Source: Northwestern University
• Contact: Emily Jungheim, MD, MSCI
• Phone: 312-926-6643
• Email: Emily.Jungheim[@]nm.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of the PROMISE study is to determine how pre-conception lifestyle factors (e.g., sleep, nutrition, physical activity) affect short- and long-term reproductive outcomes.

Description:

The overall goal of the PROMISE study is to identify strategies to improve health outcomes for women and their children. The proposed study is important and novel as it aims to capture women before they are pregnant. Current research on maternal and child health often focuses on women who are already pregnant. This time period is likely too late to make a meaningful clinical impact on long term maternal and child health outcomes influenced by social and epidemiologic determinants of health as important epigenetic changes are or have already taken place. Examples of tools that will be used to capture social and epidemiologic data include validated surveys for nutrition, physical activity, sleep, and stress. The importance of these tools is that many of the data points captured are modifiable, and therefore if associations are noted between these data points and health outcomes, actionable interventions may be developed and implemented for women who are preconceptional.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2046
• Est. primary completion date: December 2046
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Women ages 18-44 seeking pregnancy at Northwestern Fertility and Reproductive Medicine (FRM) who agree to

1. Be followed for a period for up to 25 years

2. Share information regarding their child's health

• No prior IVF cycles

Exclusion Criteria:

• Women using donor oocytes or gestational carriers
• Inability or unwillingness to provide informed consent for any aspects of the study

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Locations

Country	Name	City	State
United States	Northwestern Medicine Fertility and Reproductive Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth after embryo transfer	Live birth after embryo transfer (y/n)	~0-24 months
Secondary	Cycle number	IVF cycle number	~0-24 months
Secondary	AMH	Most recent AMH	~0-24 months
Secondary	Antral follicle count (AFC)	Most recent AFC	~0-24 months
Secondary	Diagnosis/reason for ART	E.g., male factor, DOR, tubal factor	~0-24 months
Secondary	Stimulation type	Antagonist, microcode flare, long agonist, minimal stimulation	~0-24 months
Secondary	Total gonadotropin dose (IU/L)	Total gonadotropin dose	~0-24 months
Secondary	Maximum estradiol level (pmol/L)	Maximum estradiol level	~0-24 months
Secondary	Days of stimulation	Total number of days of stimulation	~0-24 months
Secondary	Trigger type		~0-24 months
Secondary	Sperm source		~0-24 months
Secondary	Number follicles >14 mm		~0-24 months
Secondary	Cycle cancellation	Cycle cancellation (Y/N). If Y, reason for cancellation	~0-24 months
Secondary	Number of oocytes retrieved		~0-24 months
Secondary	Number of mature oocytes		~0-24 months
Secondary	Number of blastocysts		~0-24 months
Secondary	Number of embryos transferred		~0-24 months
Secondary	Day of embryo transfer		~0-24 months
Secondary	Type of embryo transfer	Frozen or fresh embryo transfer	~0-24 months
Secondary	Frozen embryo transfer protocol		~0-24 months
Secondary	Luteal phase support		~0-24 months
Secondary	Number of embryos cryopreserved		~0-24 months
Secondary	Stage of embryo cryopreservation		~0-24 months
Secondary	Grade of embryo transferred		~0-24 months
Secondary	PGT		~0-24 months
Secondary	PGT indication		~0-24 months
Secondary	PGT methodology		~0-24 months
Secondary	Endometrial thickness		~0-24 months
Secondary	Ovarian hyperstimulation syndrome		~0-24 months
Secondary	Clinical outcome		~0-24 months
Secondary	Insemination Type	ICSI, conventional, split	~0-24 months
Secondary	Singleton pregnancy		~12-36 months
Secondary	Multiple gestation		~12-36 months
Secondary	Asthma		~12-36 months
Secondary	Gestational diabetes		~12-36 months
Secondary	Insulin		~12-36 months
Secondary	Gestational hypertension/pre-eclampsia		~12-36 months
Secondary	Abruption		~12-36 months
Secondary	Placental disorders	Placenta accreta, Placenta previa, Placenta increta, Placenta percreta	~12-36 months
Secondary	Intrauterine growth restriction		~12-36 months
Secondary	Congenital malformation	Cleft palate, genetic defect, limb defect, cardiac defect, other	~12-36 months
Secondary	Thyroid disease		~12-36 months
Secondary	Heart disease		~12-36 months
Secondary	Renal disease		~12-36 months
Secondary	Polyhydramnios		~12-36 months
Secondary	Lupus		~12-36 months
Secondary	Clinical chorioamnionitis		~12-36 months
Secondary	Prenatal genetic testing		~12-36 months
Secondary	Type of prenatal genetic testing	NIPT, CVS, amniocentesis	~12-36 months
Secondary	Maternal blood type		~12-36 months
Secondary	Preconception COVID vaccination		~12-36 months
Secondary	Pregnancy COVID vaccination		~12-36 months
Secondary	Predelivery hospitalization		~12-36 months
Secondary	Maternal weight at oocyte retrieval	Weight (lbs)	~12-36 months
Secondary	Maternal height at oocyte retrieval	Height (inches)	~12-36 months
Secondary	Number of mature oocytes inseminated		~0-24 months
Secondary	Number of mature oocytes fertilized (2PN)		~0-24 months
Secondary	Maternal weight at embryo transfer		~12-36 months
Secondary	Maternal weight at last OB visit		~12-36 months
Secondary	Maternal weight at 1 year postpartum		~12-36 months
Secondary	Date of delivery		~12-36 months
Secondary	Time of delivery		~12-36 months
Secondary	Weight at delivery		~12-36 months
Secondary	Mode of delivery		~12-36 months
Secondary	Preterm birth	Birth <37 weeks	~12-36 months
Secondary	Spontaneous preterm birth		~12-36 months
Secondary	Presentation of spontaneous preterm birth (if applicable)		~12-36 months
Secondary	Tocolytic medication during pregnancy		~12-36 months
Secondary	Gestational age at delivery		~12-36 months
Secondary	Presentation of term birth (if applicable)		~12-36 months
Secondary	Magnesium sulfate administered		~12-36 months
Secondary	Intrapartum antibiotics		~12-36 months
Secondary	Length of hospital stay		~12-36 months
Secondary	Head circumference		~12-36 months
Secondary	Maternal mortality		~12-36 months
Secondary	Infection		~12-36 months
Secondary	Anesthetic complication		~12-36 months
Secondary	Antepartum hemorrhage		~12-36 months
Secondary	Postpartum hemorrhage		~12-36 months
Secondary	Blood transfusion		~12-36 months
Secondary	Thromboembolism		~12-36 months
Secondary	Birthweight		~12-36 months
Secondary	Small-for-gestational age		~12-36 months
Secondary	Large-for-gestational age		~12-36 months
Secondary	1-min APGAR score		~12-36 months
Secondary	5-min APGAR score		~12-36 months
Secondary	Arterial umbilical cord pH		~12-36 months
Secondary	Breastfeeding compliance		~12-48 months
Secondary	Postpartum weight change		~12-48 months
Secondary	General well-being		~12-48 months
Secondary	Length of NICU stay		~12-48 months
Secondary	Neonatal death	<28 days post delivery	~12-48 months
Secondary	Breastfeeding		~12-48 months
Secondary	Supplemental formula		~12-48 months
Secondary	Breastfeeding at 1 year of life		~12-48 months
Secondary	Child weight at 1 year of life		~12-48 months
Secondary	Child height at 1 year of life		~12-48 months
Secondary	NICU admission		~12-48 months