N/A
N=79
Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss
Weight Loss · Anovulation · Amenorrhea · Infertility
Bottom Line
View on ClinicalTrials.gov: NCT01785719 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Change From Baseline Ovulatory/Menstrual Function — 12; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Commercial Weight Loss Program (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Cornell University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Ovulatory/Menstrual Function |
12; 18 | — |
| SECONDARY Change From Baseline Follicle Number Per Ovary |
-5; -9 | — |
| SECONDARY Change From Baseline Reproductive Hormones |
20; -5; 0.32; -0.38 | — |
| SECONDARY Change From Baseline Metabolic Status (HOMA-IR) |
-1.3; -0.9 | — |
| SECONDARY Change From Baseline Total Percent Body Fat |
-1.8; -1.6 | — |
| SECONDARY Change From Baseline Ovarian Volume |
-1.9; 0.9 | — |
| SECONDARY Change From Baseline Free Androgen Index (FAI) |
2; -1 | — |
| SECONDARY Change From Baseline BMI |
-2.8; -3.8 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01785719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.