Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss

Infertility Clinical Trial

Official title:

Ultrasound Characterization of Ovarian Follicle Dynamics During Weight Loss

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01785719
• Other study ID #: OSP 69298
• Secondary ID: R56HD089962R01HD
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to explore the effects of weight loss on body composition, metabolic status, reproductive hormones, and ovarian follicle development in obese women with regular menstrual cycles versus obese women with irregular menstrual cycles and/or polycystic ovary syndrome (PCOS).

Description:

Polycystic ovary syndrome (PCOS) is a complex endocrine condition that impacts one in ten women of reproductive age worldwide. It is characterized by a collection of signs and symptoms, including: (1) oligo- or anovulation, (2) hyperandrogenism, and (3) polycystic ovarian morphology. Because obesity worsens the reproductive and metabolic features of the condition, lifestyle intervention aimed at weight loss is recommended as the first-line therapy in overweight / obese patients. Many studies have shown that modest weight loss (5-10%) can improve symptomology in women with PCOS. Yet, the mechanism whereby weight loss might stimulate ovulation or restore menstrual cyclicity remains unclear.

Hence, the goal of this study is to explore the effects of weight loss on body composition, metabolic status, reproductive hormones, and ovarian follicle development in obese women with regular menstrual cycles versus obese women with irregular menstrual cycles and/or PCOS. The researchers believe that a hypocaloric and low-glycemic index eating pattern, based on the nutrition recommendations of the USDA Dietary Guidelines for Americans and American Diabetes Association, will reduce endocrine and metabolic disturbances and consequently improve ovulatory and menstrual cyclicity in PCOS.

To accomplish this objective, the researchers plan to recruit up to 50 obese (i.e. body mass index >30 kg/m*m) women with regular menstrual cycles and up to 50 obese women with irregular menstrual cycles and/or PCOS. Exclusion criteria will include ages <18 or >35 y and the use of hormonal contraception, fertility therapy, or insulin-sensitizing medication in the three months prior to enrollment. This study entails one month of data collection during a baseline interval (Month 1) and six months of data collection during a commercial weight loss program (Nutrisystem® D; Month 2 thru Month 7).

Participants will be evaluated every other day (in Months 1 and 7) or twice per week (in Months 2 thru 6) by transvaginal ultrasonography and venipuncture. Ultrasound images of the ovaries will be assessed for the total number and diameter of individual follicles. Serum samples will be assessed for follicle-stimulating hormone, luteinizing hormone, estradiol, and progesterone. Participants will also be evaluated at up to four time points using multiple metabolic and behavioral tests. Time points of interest will include: (1) Month 1 (i.e. pre-intervention), (2) after 5% weight loss, (3) after 10% weight loss, and (4) Month 7 (i.e. post-intervention). Assessments and endpoints of interest will include: (1) fasting blood tests (to detect serum androgens and markers of metabolic syndrome); (2) an oral glucose tolerance test (to characterize glucose and insulin dynamics at 0, 30, 60, 90, and 120-minutes post-glucose ingestion); (3) a physical examination (to measure height, weight, waist and hips circumference, blood pressure, heart rate, and hirsutism score); (4) a dual x-ray absorptiometry scan (to quantify total and regional fat and lean mass); and (5) a quality of life questionnaire (to evaluate health-related quality of life).

To evaluate further changes in ovarian morphology, reproductive hormones, metabolic status, and body composition after the intervention, participants will be invited to return to the research unit six months after the study ends. The aforementioned procedures (transvaginal ultrasound scan; fasting blood tests; oral glucose tolerance test; physical examination; dual x-ray absorptiometry scan; and quality of life questionnaire) will be repeated.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: July 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• BMI = 30.0 kg/m*m.

• Self-reported history of regular menstrual cycles, irregular menstrual cycles, or PCOS.

• Absence of hormonal contraception, fertility therapy, or insulin-sensitizing medication in the three months prior to enrollment.

Exclusion Criteria:

• Pregnant, breastfeeding, or lactating

• Lack of one or both ovaries and/or uterus

• Previous diagnosis of bleeding disorder(s) or current use of blood thinners/anticoagulants

• Vegan or gluten free

• Soy or peanut allergy

Related Conditions & MeSH terms

• Amenorrhea
• Anovulation
• Body Weight
• Infertility
• Weight Loss

Intervention

Behavioral:
• Commercial Weight Loss Program
Regardless of reproductive history, each participant will be provided with six months of the commercial weight loss program, Nutrisystem® D. Nutrisystem® D is a portion-controlled, low calorie, and low glycemic index meal delivery system that provides 1250-1500 kcal/day. It has been proven to help overweight adults achieve real and sustainable weight loss results. When meals and snacks are consumed as instructed, average weight loss is 1-2 lbs per week or 15-20% body weight by the end of six months. Nutrisystem® D offers a balanced meal plan that is consistent with the nutrition recommendations of the USDA Dietary Guidelines for Americans and American Diabetes Association. Each participant will be encouraged to take a daily multivitamin to help meet her micronutrient needs on the program.

Locations

Country	Name	City	State
United States	Cornell University - Human Metabolic Research Unit	Ithaca	New York

Sponsors (3)

Lead Sponsor	Collaborator
Cornell University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Nutrisystem, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Ovulatory Function	Ovulation will be identified by the disappearance of a dominant follicle and subsequent appearance of a corpus luteum on ultrasonography. The event will be confirmed by a corresponding increase in serum progesterone.	Up to 7 months
Secondary	Change from Baseline Menstrual Function	Menses will be confirmed by participant self-report of uterine bleeding.	through study completion, an average of 13 months
Secondary	Change from Baseline Ovarian Morphology	Information about the associated procedures and endpoints are provided elsewhere.	through study completion, an average of 13 months
Secondary	Change from Baseline Reproductive Hormones	Information about the associated procedures and endpoints are provided elsewhere.	through study completion, an average of 13 months
Secondary	Change from Baseline Metabolic Status	Information about the associated procedures and endpoints are provided elsewhere.	through study completion, an average of 13 months
Secondary	Change from Baseline Body Composition	Information about the associated procedures and endpoints are provided elsewhere.	through study completion, an average of 13 months