Healthy Conceptions for Couples Intervention Pilot Study

Overview

Status: Recruiting
Keywords: Infertility , Obesity , polycystic ovarian syndrome , emotionally focused therapy , weight loss
IRB Number: 00062463
Specialty: Reproductive Endocrinology and Infertility
Sub Specialties:

Brief Summary

Hypothesis: The addition of Emotionally Focused couples Therapy (EFT) to lifestyle change in women with obesity and anovulation will improve weight loss, address psychological needs (depression, attachment injury and health trauma) and improve fertility in obesity-related infertility.  We posit that the novel features in this proposal will increase behavioral self-efficacy through enhancing mood and the family support system compared to lifestyle interventions alone, and synergistically improve fertility by simultaneously addressing male and female physical and psychological challenges: depression, attachment injury, and health trauma.

The primary outcome will be assessed upon completion of six months of weight loss for the female partner.  Additional outcome measures will include changes in weight in both partners, and change in quality of life, mood, and couples attachment over the course of the study.  If effectiveness trends are observed, results from this pilot study will be used to design a larger randomized trial comparing medically supervised weight loss with and without EFT to standard clinical weight loss counseling.  While this pilot study is designed to detect weight loss and assess enrollment feasibility, a larger study will be powered to detect improved fertility and pregnancy outcomes. 

SPECIFIC AIMS

Aim #1:  In this pilot feasibility study, demonstrate the effectiveness of a couples multidisciplinary lifestyle support program, including supervised medical weight loss and emotionally focused couples therapy (EFT), in aiding weight loss in overweight, infertile women with obesity and anovulation and their overweight or obese partners.

Aim #2: In future study, demonstrate improvements in ovulatory frequency, sperm count, sperm DNA fragmentation, spontaneous conception rate, responsiveness to ovulation induction, impaired fasting glucose, systemic inflammation, fertility-related quality of life, depression, couples bonding, multiple pregnancies, preterm delivery, gestational diabetes, hypertensive disorders of pregnancy, NICU admission rate and cost per live birth following a couples multidisciplinary lifestyle support program.

Principal Investigator: Andrew Moore
Department: Obstetrics And Gynecology (Dept)
Co Investigator: Erica Johnstone

Contact Information

Name:Andrew Moore
Phone: 801-587-3834
Email: andrew.moore@hsc.utah.edu

Inclusion Criteria

Inclusion criteria:

1.     Heterosexual couple currently desiring to conceive.

2.     Female partner with BMI ≥ 30

3.     Male Partner with BMI  ≥ 30

4.     Female partner age < 35

5.     Female partner with oligomenorrhea as defined by history of four or fewer spontaneous menstrual cycles during past 6 months.  Women who require medication to induce menses meet this criteria.

6.     One of two criteria: 6 months of infertility and oligomenorrhea, as defined above OR 3 months of amenorrhea

Exclusion Criteria

Exclusion criteria (for female partner unless otherwise indicated)

1.     Anovulation disorder due to hypothalamic dysfunction, hyperprolactinemia, hypothyroidism, or other endocrine disorder.

2.     Cardiovascular disease, including history of MI, stroke, diagnosed coronary heart disease, or arrhythmia impairing ability to be physically active.

3.     Poorly-controlled hypertension (BP >160 systolic or >100 diastolic)

4.     Poorly controlled diabetes (HgbA1c >7.0%)

5.     Any known health condition impairing ability to participate in aerobic exercise.

6.     Currently taking pregnancy category D or X medications.

7.     Infertility known to be due to azoospermia.